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Trinity Sterile, Inc. FDA Recalls
10 recalls on file across devices, 0 of them Class I and 5 still open. This firm is not matched to a listed company.
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Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.
| Product |
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| Brand Name: Wolf-Pak Product Name: Dressing Change Kit with Cloth Border Tegaderm Dressing & 3mL CHG One Step ApplicatoClass IIDec 13, 2024Potential for hole in package compromising sterility of the |
| Brand Name: IMed Products Product Name: Dressing Change Kit with ChloraPrep 3mL & HaloGUARD Model/Catalog Number: IM46Class IIDec 13, 2024Potential for hole in package compromising sterility of the |
| Brand Name: Wolf-Pak Product Name: Dressing Change Kit with Transparent Dressing & 3mL CHG One Step Applicator CS/30 MClass IIDec 13, 2024Potential for hole in package compromising sterility of the |
| Brand Name: Wolf-Pak Product Name: Premium Dressing Change Kit with GuardiVa & Statlock CS/30 Model/Catalog Number: DCClass IIDec 13, 2024Potential for hole in package compromising sterility of the |
| Brand Name: Tacy Medical, Inc. Product Name: Dressing Change Tray CS/20 Model/Catalog Number: TM6180CP Software VersiClass IIDec 13, 2024Potential for hole in package compromising sterility of the |
| Wolf-Pak Premium Dressing Kit with GuardVA Cs/30 Ref: DC5030LFClass IIJun 29, 2022Kits mislabeled as latex-free, the packaging for component 9 |
| Sklar Instruments IV Cath Dressing Tray Cs/25 Re-Order Number: 96-1708Class IIJun 29, 2022Kits mislabeled as latex-free, the packaging for component 9 |
| Wolf Pak Premium Dressing Change Kit with Statlock CS/30 Ref: DC5040LFClass IIJun 29, 2022Kits mislabeled as latex-free, the packaging for component 9 |
| Wolf Pak Premium Dressing Change Kit with GuardVA and Statlok Cs/30 Ref: DC5090LFClass IIJun 29, 2022Kits mislabeled as latex-free, the packaging for component 9 |
| Midline Catheter Dressing Change Kit with Statlock - Product Usage: Intended to provide ongoing vascular catheter mainteClass IIFeb 23, 2021Evidence of face masks or other material in the seal in seve |