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Teleflex LLC FDA Recalls
140 recalls on file across devices, 129 of them Class I and 139 still open. Matched by name to TFX.
Newest first
Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.
| Product |
|---|
| Brand Name: Pilling Wecksorb Product Name: Pilling Wecksorb Neurosponges (Cotton) Pilling¿ Wecksorb Neurosponge StripsClass IIMay 7, 2026Due to out-of-specification, or potential out-of-specificati |
| Slick Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 170090Class IMay 25, 2023Reports of disconnection of the 15mm connector from the endo |
| Preformed AGT Oral Endotracheal Tube Murphy Eye, High Volume, Low Pressure Cuff, REF 111780075Class IMay 25, 2023Reports of disconnection of the 15mm connector from the endo |
| RUSCHELIT Safety Clear Tracheal Tube, oral/nasal, Magill, REF 112480035Class IMay 25, 2023Reports of disconnection of the 15mm connector from the endo |
| RUSCHELIT Safety Clear Tracheal Tube, oral/nasal, Magill, REF 112480025Class IMay 25, 2023Reports of disconnection of the 15mm connector from the endo |
| Endotracheal Tube oral/nasal Magill, High Volume, Low Pressure Cuff, REF 112080050Class IMay 25, 2023Reports of disconnection of the 15mm connector from the endo |
| Slick Set Uncuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 150020Class IMay 25, 2023Reports of disconnection of the 15mm connector from the endo |
| Preformed AGT Oral Endotracheal Tube Murphy Eye, High Volume, Low Pressure Cuff, REF 111780060Class IMay 25, 2023Reports of disconnection of the 15mm connector from the endo |
| Preformed AGT Oral Endotracheal Tube Murphy Eye, High Volume, Low Pressure Cuff, REF 111780085Class IMay 25, 2023Reports of disconnection of the 15mm connector from the endo |
| Preformed AGT Oral Endotracheal Tube uncuffed/plain - Murphy, REF 100181040Class IMay 25, 2023Reports of disconnection of the 15mm connector from the endo |
| Preformed AGT Oral Endotracheal Tube uncuffed/plain - Murphy, REF 100181055Class IMay 25, 2023Reports of disconnection of the 15mm connector from the endo |
| Slick Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 170085Class IMay 25, 2023Reports of disconnection of the 15mm connector from the endo |
| Endotracheal Tube oral/nasal Magill, High Volume, Low Pressure Cuff, REF 112080100Class IMay 25, 2023Reports of disconnection of the 15mm connector from the endo |
| Endotracheal Tube oral/nasal Murphy Eye, High Volume, Low Pressure Cuff, REF 112082065Class IMay 25, 2023Reports of disconnection of the 15mm connector from the endo |
| Endotracheal Tube oral/nasal Magill, High Volume, Low Pressure Cuff, REF 112080065Class IMay 25, 2023Reports of disconnection of the 15mm connector from the endo |
| Slick Set Uncuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 150040Class IMay 25, 2023Reports of disconnection of the 15mm connector from the endo |
| Flexi-Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 504580Class IMay 25, 2023Reports of disconnection of the 15mm connector from the endo |
| Endotracheal Tube oral/nasal Magill, High Volume, Low Pressure Cuff, REF 112080070Class IMay 25, 2023Reports of disconnection of the 15mm connector from the endo |
| Preformed AGT Oral Endotracheal Tube Murphy Eye, High Volume, Low Pressure Cuff, REF 111780070Class IMay 25, 2023Reports of disconnection of the 15mm connector from the endo |
| Slick Set Uncuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 170125Class IMay 25, 2023Reports of disconnection of the 15mm connector from the endo |
| Preformed AGT Oral Endotracheal Tube Murphy Eye, High Volume, Low Pressure Cuff, REF 111781050Class IMay 25, 2023Reports of disconnection of the 15mm connector from the endo |
| Preformed AGT Oral Endotracheal Tube uncuffed/plain - Murphy, REF 100180040Class IMay 25, 2023Reports of disconnection of the 15mm connector from the endo |
| Endotracheal Tube oral/nasal Magill, High Volume, Low Pressure Cuff, REF 112080090Class IMay 25, 2023Reports of disconnection of the 15mm connector from the endo |
| Preformed AGT Oral Endotracheal Tube uncuffed/plain - Murphy, REF 100180035Class IMay 25, 2023Reports of disconnection of the 15mm connector from the endo |
| Endotracheal Tube oral/nasal uncuffed/plain - Magill, REF 100380035Class IMay 25, 2023Reports of disconnection of the 15mm connector from the endo |
| Slick Set Uncuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 150030Class IMay 25, 2023Reports of disconnection of the 15mm connector from the endo |
| Preformed AGT Oral Endotracheal Tube Murphy Eye, High Volume, Low Pressure Cuff, REF 111781035Class IMay 25, 2023Reports of disconnection of the 15mm connector from the endo |
| Preformed AGT Oral Endotracheal Tube Murphy Eye, High Volume, Low Pressure Cuff, REF 111781080Class IMay 25, 2023Reports of disconnection of the 15mm connector from the endo |
| Preformed AGT Oral Endotracheal Tube Murphy Eye, High Volume, Low Pressure Cuff, REF 111780080Class IMay 25, 2023Reports of disconnection of the 15mm connector from the endo |
| Flexi-Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 504560Class IMay 25, 2023Reports of disconnection of the 15mm connector from the endo |
| RUSCHELIT Safety Clear Tracheal Tube, oral/nasal, Magill, REF 112480030Class IMay 25, 2023Reports of disconnection of the 15mm connector from the endo |
| Preformed AGT Oral Endotracheal Tube uncuffed/plain - Murphy, REF 100180060Class IMay 25, 2023Reports of disconnection of the 15mm connector from the endo |
| Endotracheal Tube oral/nasal uncuffed/plain - Magill, REF 100380060Class IMay 25, 2023Reports of disconnection of the 15mm connector from the endo |
| Preformed AGT Oral Endotracheal Tube uncuffed/plain - Murphy, REF 100181050Class IMay 25, 2023Reports of disconnection of the 15mm connector from the endo |
| Endotracheal Tube oral/nasal Murphy Eye, High Volume, Low Pressure Cuff, REF 112082060Class IMay 25, 2023Reports of disconnection of the 15mm connector from the endo |
| Endotracheal Tube oral/nasal Magill, High Volume, Low Pressure Cuff, REF 112080080Class IMay 25, 2023Reports of disconnection of the 15mm connector from the endo |
| Endotracheal Tube oral/nasal uncuffed/plain - Magill, REF 100380025Class IMay 25, 2023Reports of disconnection of the 15mm connector from the endo |
| Slick Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 170095Class IMay 25, 2023Reports of disconnection of the 15mm connector from the endo |
| Slick Set Uncuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 150025Class IMay 25, 2023Reports of disconnection of the 15mm connector from the endo |
| Endotracheal Tube oral/nasal uncuffed/plain - Murphy, REF 100382045Class IMay 25, 2023Reports of disconnection of the 15mm connector from the endo |
| Preformed AGT Oral Endotracheal Tube Murphy Eye, High Volume, Low Pressure Cuff, REF 111781065Class IMay 25, 2023Reports of disconnection of the 15mm connector from the endo |
| Slick Set Uncuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 170120Class IMay 25, 2023Reports of disconnection of the 15mm connector from the endo |
| Preformed AGT Oral Endotracheal Tube Murphy Eye, High Volume, Low Pressure Cuff, REF 111780065Class IMay 25, 2023Reports of disconnection of the 15mm connector from the endo |
| Pilling O'REILLY ESOPHAGEAL RETRACTOR, REF 381801A; ENT retractorClass IIMay 25, 2023There are incomplete pre-cleaning instructions within the In |
| Endotracheal Tube oral/nasal uncuffed/plain - Magill, REF 100380055Class IMay 25, 2023Reports of disconnection of the 15mm connector from the endo |
| Slick Set Uncuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 150055Class IMay 25, 2023Reports of disconnection of the 15mm connector from the endo |
| Endotracheal Tube oral/nasal Magill, High Volume, Low Pressure Cuff, REF 112080095Class IMay 25, 2023Reports of disconnection of the 15mm connector from the endo |
| Preformed AGT Oral Endotracheal Tube uncuffed/plain - Murphy, REF 100180065Class IMay 25, 2023Reports of disconnection of the 15mm connector from the endo |
| Endotracheal Tube oral/nasal uncuffed/plain - Murphy, REF 100382065Class IMay 25, 2023Reports of disconnection of the 15mm connector from the endo |
| Endotracheal Tube oral/nasal uncuffed/plain - Murphy, REF 100382035Class IMay 25, 2023Reports of disconnection of the 15mm connector from the endo |
| Endotracheal Tube oral/nasal uncuffed/plain - Murphy, REF 100382050Class IMay 25, 2023Reports of disconnection of the 15mm connector from the endo |
| Endotracheal Tube oral/nasal Magill, High Volume, Low Pressure Cuff, REF 112080075Class IMay 25, 2023Reports of disconnection of the 15mm connector from the endo |
| RUSCHELIT Safety Clear Tracheal Tube, oral/nasal, Magill, REF 112480045Class IMay 25, 2023Reports of disconnection of the 15mm connector from the endo |
| Endotracheal Tube oral/nasal uncuffed/plain - Murphy, REF 100382055Class IMay 25, 2023Reports of disconnection of the 15mm connector from the endo |
| Endotracheal Tube oral/nasal Murphy Eye, High Volume, Low Pressure Cuff, REF 112082075Class IMay 25, 2023Reports of disconnection of the 15mm connector from the endo |
| Flexi-Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 504555Class IMay 25, 2023Reports of disconnection of the 15mm connector from the endo |
| Preformed AGT Oral Endotracheal Tube Murphy Eye, High Volume, Low Pressure Cuff, REF 111780045Class IMay 25, 2023Reports of disconnection of the 15mm connector from the endo |
| Endotracheal Tube oral/nasal uncuffed/plain - Murphy, REF 100382060Class IMay 25, 2023Reports of disconnection of the 15mm connector from the endo |
| Flexi-Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 504590Class IMay 25, 2023Reports of disconnection of the 15mm connector from the endo |
| Endotracheal Tube oral/nasal uncuffed/plain - Murphy, REF 100382040Class IMay 25, 2023Reports of disconnection of the 15mm connector from the endo |
| Preformed AGT Oral Endotracheal Tube uncuffed/plain - Murphy, REF 100180045Class IMay 25, 2023Reports of disconnection of the 15mm connector from the endo |
| Endotracheal Tube oral/nasal Murphy Eye, High Volume, Low Pressure Cuff, REF 112082095Class IMay 25, 2023Reports of disconnection of the 15mm connector from the endo |
| Slick Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 170075Class IMay 25, 2023Reports of disconnection of the 15mm connector from the endo |
| Slick Set Uncuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 170135Class IMay 25, 2023Reports of disconnection of the 15mm connector from the endo |
| Preformed AGT Oral Endotracheal Tube Murphy Eye, High Volume, Low Pressure Cuff, REF 111781045Class IMay 25, 2023Reports of disconnection of the 15mm connector from the endo |
| Preformed AGT Oral Endotracheal Tube uncuffed/plain - Murphy, REF 100181065Class IMay 25, 2023Reports of disconnection of the 15mm connector from the endo |
| Flexi-Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 504565Class IMay 25, 2023Reports of disconnection of the 15mm connector from the endo |
| Flexi-Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 504550Class IMay 25, 2023Reports of disconnection of the 15mm connector from the endo |
| Endotracheal Tube oral/nasal Murphy Eye, High Volume, Low Pressure Cuff, REF 112082085Class IMay 25, 2023Reports of disconnection of the 15mm connector from the endo |
| Slick Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 170055Class IMay 25, 2023Reports of disconnection of the 15mm connector from the endo |
| Flexi-Set Uncuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 506535Class IMay 25, 2023Reports of disconnection of the 15mm connector from the endo |
| Endotracheal Tube oral/nasal uncuffed/plain - Magill, REF 100380040Class IMay 25, 2023Reports of disconnection of the 15mm connector from the endo |
| Endotracheal Tube oral/nasal Magill, High Volume, Low Pressure Cuff, REF 112080085Class IMay 25, 2023Reports of disconnection of the 15mm connector from the endo |
| Slick Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 170050Class IMay 25, 2023Reports of disconnection of the 15mm connector from the endo |
| Slick Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 170080Class IMay 25, 2023Reports of disconnection of the 15mm connector from the endo |
| Slick Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 170070Class IMay 25, 2023Reports of disconnection of the 15mm connector from the endo |
| Slick Set Uncuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 170155Class IMay 25, 2023Reports of disconnection of the 15mm connector from the endo |
| Flexi-Set Uncuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 506530Class IMay 25, 2023Reports of disconnection of the 15mm connector from the endo |
| Endotracheal Tube oral/nasal uncuffed/plain - Magill, REF 100380030Class IMay 25, 2023Reports of disconnection of the 15mm connector from the endo |
| Endotracheal Tube oral/nasal uncuffed/plain - Magill, REF 100380045Class IMay 25, 2023Reports of disconnection of the 15mm connector from the endo |
| Endotracheal Tube oral/nasal Murphy Eye, High Volume, Low Pressure Cuff, REF 112082090Class IMay 25, 2023Reports of disconnection of the 15mm connector from the endo |
| Slick Set Uncuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 150035Class IMay 25, 2023Reports of disconnection of the 15mm connector from the endo |
| Preformed AGT Oral Endotracheal Tube Murphy Eye, High Volume, Low Pressure Cuff, REF 111781055Class IMay 25, 2023Reports of disconnection of the 15mm connector from the endo |
| Flexi-Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 504575Class IMay 25, 2023Reports of disconnection of the 15mm connector from the endo |
| Endotracheal Tube oral/nasal uncuffed/plain - Murphy, REF 100382025Class IMay 25, 2023Reports of disconnection of the 15mm connector from the endo |
| Endotracheal Tube oral/nasal Magill, High Volume, Low Pressure Cuff, REF 112080055Class IMay 25, 2023Reports of disconnection of the 15mm connector from the endo |
| Slick Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 170060Class IMay 25, 2023Reports of disconnection of the 15mm connector from the endo |
| Endotracheal Tube oral/nasal uncuffed/plain - Magill, REF 100380065Class IMay 25, 2023Reports of disconnection of the 15mm connector from the endo |
| Preformed AGT Oral Endotracheal Tube uncuffed/plain - Murphy, REF 100180070Class IMay 25, 2023Reports of disconnection of the 15mm connector from the endo |
| Preformed AGT Oral Endotracheal Tube Murphy Eye, High Volume, Low Pressure Cuff, REF 111780050Class IMay 25, 2023Reports of disconnection of the 15mm connector from the endo |
| Endotracheal Tube oral/nasal uncuffed/plain - Magill, REF 100380050Class IMay 25, 2023Reports of disconnection of the 15mm connector from the endo |
| Slick Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 170065Class IMay 25, 2023Reports of disconnection of the 15mm connector from the endo |
| Slick Set Uncuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 170140Class IMay 25, 2023Reports of disconnection of the 15mm connector from the endo |
| Slick Set Uncuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 170145Class IMay 25, 2023Reports of disconnection of the 15mm connector from the endo |
| Flexi-Set Uncuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 506525Class IMay 25, 2023Reports of disconnection of the 15mm connector from the endo |
| Preformed AGT Oral Endotracheal Tube uncuffed/plain - Murphy, REF 100181045Class IMay 25, 2023Reports of disconnection of the 15mm connector from the endo |
| Preformed AGT Oral Endotracheal Tube Murphy Eye, High Volume, Low Pressure Cuff, REF 111780055Class IMay 25, 2023Reports of disconnection of the 15mm connector from the endo |
| Endotracheal Tube oral/nasal Murphy Eye, High Volume, Low Pressure Cuff, REF 112082070Class IMay 25, 2023Reports of disconnection of the 15mm connector from the endo |
| Slick Set Uncuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 170130Class IMay 25, 2023Reports of disconnection of the 15mm connector from the endo |
| Preformed AGT Oral Endotracheal Tube uncuffed/plain - Murphy, REF 100180050Class IMay 25, 2023Reports of disconnection of the 15mm connector from the endo |
| Pilling LOWSLEY PROSTATIC TRACTOR CVD, REF 243200; retractorClass IIMay 25, 2023There are incomplete pre-cleaning instructions within the In |
| Preformed AGT Oral Endotracheal Tube Murphy Eye, High Volume, Low Pressure Cuff, REF 111781060Class IMay 25, 2023Reports of disconnection of the 15mm connector from the endo |
| Endotracheal Tube oral/nasal Murphy Eye, High Volume, Low Pressure Cuff, REF 112082080Class IMay 25, 2023Reports of disconnection of the 15mm connector from the endo |
| Flexi-Set Uncuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 506545Class IMay 25, 2023Reports of disconnection of the 15mm connector from the endo |
| Endotracheal Tube oral/nasal uncuffed/plain - Murphy, REF 100382030Class IMay 25, 2023Reports of disconnection of the 15mm connector from the endo |
| Preformed AGT Oral Endotracheal Tube uncuffed/plain - Murphy, REF 100181060Class IMay 25, 2023Reports of disconnection of the 15mm connector from the endo |
| Slick Set Uncuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 170150Class IMay 25, 2023Reports of disconnection of the 15mm connector from the endo |
| Flexi-Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 504570Class IMay 25, 2023Reports of disconnection of the 15mm connector from the endo |
| Flexi-Set Uncuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 506550Class IMay 25, 2023Reports of disconnection of the 15mm connector from the endo |
| Slick Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 1700100Class IMay 25, 2023Reports of disconnection of the 15mm connector from the endo |
| Endotracheal Tube oral/nasal Magill, High Volume, Low Pressure Cuff, REF 112080060Class IMay 25, 2023Reports of disconnection of the 15mm connector from the endo |
| Preformed AGT Oral Endotracheal Tube uncuffed/plain - Murphy, REF 100180055Class IMay 25, 2023Reports of disconnection of the 15mm connector from the endo |
| Preformed AGT Oral Endotracheal Tube uncuffed/plain - Murphy, REF 100180030Class IMay 25, 2023Reports of disconnection of the 15mm connector from the endo |
| Preformed AGT Oral Endotracheal Tube Murphy Eye, High Volume, Low Pressure Cuff, REF 111781040Class IMay 25, 2023Reports of disconnection of the 15mm connector from the endo |
| Preformed AGT Oral Endotracheal Tube Murphy Eye, High Volume, Low Pressure Cuff, REF 111781070Class IMay 25, 2023Reports of disconnection of the 15mm connector from the endo |
| Preformed AGT Oral Endotracheal Tube Murphy Eye, High Volume, Low Pressure Cuff, REF 111781075Class IMay 25, 2023Reports of disconnection of the 15mm connector from the endo |
| Flexi-Set Uncuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 506540Class IMay 25, 2023Reports of disconnection of the 15mm connector from the endo |
| Preformed AGT Oral Endotracheal Tube Murphy Eye, High Volume, Low Pressure Cuff, REF 111780040Class IMay 25, 2023Reports of disconnection of the 15mm connector from the endo |
| Endotracheal Tube oral/nasal Murphy Eye, High Volume, Low Pressure Cuff, REF 112082050Class IMay 25, 2023Reports of disconnection of the 15mm connector from the endo |
| Preformed AGT Oral Endotracheal Tube Murphy Eye, High Volume, Low Pressure Cuff, REF 111780090Class IMay 25, 2023Reports of disconnection of the 15mm connector from the endo |
| Preformed AGT Oral Endotracheal Tube Murphy Eye, High Volume, Low Pressure Cuff, REF 111780035Class IMay 25, 2023Reports of disconnection of the 15mm connector from the endo |
| Preformed AGT Oral Endotracheal Tube uncuffed/plain - Murphy, REF 100181030Class IMay 25, 2023Reports of disconnection of the 15mm connector from the endo |
| Endotracheal Tube oral/nasal Murphy Eye, High Volume, Low Pressure Cuff, REF 112082100Class IMay 25, 2023Reports of disconnection of the 15mm connector from the endo |
| Pilling LOWSLEY PROSTATIC TRACTOR STR, REF 243201; retractorClass IIMay 25, 2023There are incomplete pre-cleaning instructions within the In |
| RUSCHELIT Safety Clear Tracheal Tube, oral/nasal, Magill, REF 112480040Class IMay 25, 2023Reports of disconnection of the 15mm connector from the endo |
| Endotracheal Tube oral/nasal Murphy Eye, High Volume, Low Pressure Cuff, REF 112082055Class IMay 25, 2023Reports of disconnection of the 15mm connector from the endo |
| Flexi-Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 504585Class IMay 25, 2023Reports of disconnection of the 15mm connector from the endo |
| Teleflex HORIZON Microclip Titanium Ligating Clips w/tape, REF 005200; for use in general surgical procedures that requiClass IIApr 28, 2023Teleflex LLC is initiating this voluntary field corrective a |
| Teleflex (manufacturer: Vascular SOLUTIONS) D-Stat Flowable Hemostat, REF 4000; for sealing residual oozing of tissue trClass IIApr 12, 2023The product contains an expired diluent vial. If the impacte |
| Slick Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal. Intended for patients requiring endotracheal intubatClass IIDec 8, 2022Potential for pilot balloon non-inflation or cuff non-deflat |
| Endotracheal Tube labeled as the following: a. Endotracheal Tube oral/nasal Magill, High Volume, Low Pressure Cuff; Class IIDec 8, 2022Potential for pilot balloon non-inflation or cuff non-deflat |
| Endotracheal Tube labeled as the following: a. Flexi-Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal; b.Class IIDec 8, 2022Potential for pilot balloon non-inflation or cuff non-deflat |
| Pilling Wecksorb Cylindrical SpongesClass IISep 28, 2022Specific lots have not been irradiated to eliminate pyronema |
| Teleflex Medical RUSCH Pocket Pac i.c. Closed System Intermittent Catheter Kit, 14 Fr (4.7mm), REF 10096140 (IPN050116).Class IISep 20, 2022Product may not be sterile |
| Iso-Gard Filter S, with Expandi-Flex, REF: a) 19261, OUS only; b) 19272, OUS only; Microbial medical gas filter, singlClass IAug 29, 2022Incidents of device splitting or detaching during use |
| Iso-Gard Filter S, REF : a) 19211, OUS only; b) 19212; Microbial medical gas filter, single-use. Bacterial/viral filteClass IAug 29, 2022Incidents of device splitting or detaching during use |
| Iso-Gard Filter S, with Expandi-Flex, Tethered Cap, REF: a) 19261T, OUS only; b) 19262T, OUS only; c) 19272T, OUS only; Class IAug 29, 2022Incidents of device splitting or detaching during use |
| Iso-Gard Filter S, Tethered Cap, REF: a) 19211T, OUS only; b) 19212T, OUS only; Microbial medical gas filter, single-uClass IAug 29, 2022Incidents of device splitting or detaching during use |
| Iso-Gard Filter S with Expandi-Flex/Elbow: a) REF 19012, OUS only, b) REF 19012T with Tethered Cap, OUS only; MicrobialClass IAug 29, 2022Incidents of device splitting or detaching during use |
| Filter + Catheter Mount, REF 191667-000100, OUS only. Catheter mount for circuit-patient connection (Endotracheal tube aClass IAug 29, 2022Incidents of device splitting or detaching during use |