Device product
Polysorb Braided Absorbable Suture 1 36" 90 cm Undyed GS-21, Product Number CL-955
Z-2601-2018
Product summary
- Firm
- Covidien LLC
- Event
- Event 80542
- Status
- Terminated
- Classification
- Class II
- Quantity
- 972 units
- Official record key
device-enforcement:Z-2601-2018
Official wording
Reason: Potential proplylene glycol contamination
Code information: UDI - 10884521043718 /20884521043715 Lot Number - A8C0783X
Distribution pattern: CA, NY & TX
Derived failure modes
-
Unknown
Potential proplylene glycol contamination