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Stradis Healthcare FDA Recalls
20 recalls on file across devices, 0 of them Class I and 19 still open. This firm is not matched to a listed company.
Newest first
Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.
| Product |
|---|
| HCT 500mL BAGS, 2 Port, Sterile, Triple Packaged, 10 EVA BAGS/Pack, 7 Packs PER CASE. Distributed by Health Care TechnoClass IIDec 15, 2022Potential for the outer bag having pinhole leaks near the se |
| Henry Shein GLOVES, packaged in the following sizes and descriptions: a. Glove 6.5 Pack, 25 Pairs, 10 packs per case;Class IIDec 15, 2022Potential for the outer bag having pinhole leaks near the se |
| HCT MAX BARRIER PICC INSERTION TRAY 12 per case. Distributed by Health Care TechnologyClass IIDec 15, 2022Potential for the outer bag having pinhole leaks near the se |
| Tacy Medical, Inc Syringe Convenience Pack, IML L/L, Sterile, 60 packs per bag, 5 bags per case. Manufactured for TracyClass IIDec 15, 2022Potential for the outer bag having pinhole leaks near the se |
| Stradis Healthcare NEONATAL PICC Tray *PGBK* 20 trays per case. Manufactured by Stradis Healthcare, Distributed by MedClass IIDec 15, 2022Potential for the outer bag having pinhole leaks near the se |
| Tacy Medical, Inc Fluid Filter Transfer Kit, Sterile, 60 kits per bag, 5 bags per case. Manufactured for Tracy Medical,Class IIDec 15, 2022Potential for the outer bag having pinhole leaks near the se |
| Tacy Medical, Inc PORT ACCESS TRAY, Sterile, QTY 20. Manufactured for Tracy Medical, Inc.Class IIDec 15, 2022Potential for the outer bag having pinhole leaks near the se |
| McCormick Medical Distribution PORT TRAY, 25 trays per case. Distributed by McCormick Medical Distribution.Class IIDec 15, 2022Potential for the outer bag having pinhole leaks near the se |
| HCT 6 CC SYRINGE KIT, 25/TRAY, 4 TRAYS/BAG, 5 BAGS/CASE. Distributed by Health Care Technology.Class IIDec 15, 2022Potential for the outer bag having pinhole leaks near the se |
| HCT 12 CC SYRINGE KIT, 20/TRAY,5 TRAYS/BAG, 5 BAGS /CASE HCT. Distributed by Health Care Technology.Class IIDec 15, 2022Potential for the outer bag having pinhole leaks near the se |
| Stradis Healthcare TCTR Convenience Kit. Manufactured by Stradis Healthcare.Class IIDec 15, 2022Potential for the outer bag having pinhole leaks near the se |
| Stradis Healthcare Foley Catheter Insertion Tray with preconnected bag and catheter, SterileClass IIDec 15, 2022Potential for the outer bag having pinhole leaks near the se |
| Henry Shein CYSTO SET UP PACK, 20 per case. Distributed by Henry Schein.Class IIDec 15, 2022Potential for the outer bag having pinhole leaks near the se |
| HCT 50mL EVA BAGS, 2 Port, Sterile, Tripple Packaged, 20 EVA BAGS/Pack, 7 Packs PER CASE. Distributed by Health Care TeClass IIDec 15, 2022Potential for the outer bag having pinhole leaks near the se |
| PICC KIT, 10/CS, ACCESS MEDICAL LABELClass IIDec 15, 2022Potential for the outer bag having pinhole leaks near the se |
| Vital Care Products NEONATAL PICC TRAY, Sterile, QTY 20. Manufactured for Vital Care Products, Inc.Class IIDec 15, 2022Potential for the outer bag having pinhole leaks near the se |
| PHS Lacertaion Tray, Sterile, 20 per case, Manufactured for Professional Hosptial Supply, Inc.Class IIDec 15, 2022Potential for the outer bag having pinhole leaks near the se |
| HCT CENTRAL LINE Insertion Tray, I2 per case. Distributed by Health Care TechnologyClass IIDec 15, 2022Potential for the outer bag having pinhole leaks near the se |
| VYGON DRESSING CHANGE W/MAXISWAB kit, REF AMS-8465CSClass IIMay 10, 2022Potential for incomplete seals. |
| Surgical Suture KitClass IIApr 22, 2022There is uncertainty about the integrity of the methods used |