Device product
Sterile Co-Flex NL 4" - Product Usage: Single Use secondary wound dressing or compression wrap
Z-0180-2020
Product summary
- Event
- Event 83239
- Status
- Terminated
- Classification
- Class II
- Quantity
- 8500 Cases
- Official record key
device-enforcement:Z-0180-2020
Official wording
Reason: Incomplete packaging seal of sterile product
Code information: Manufacturer's product or Catalog # 5400S Expiration Date: 01OCT2021-14JUN2022 Lot # CI0PVV, CI0V78, CI0X0B, CI16CG, CI17BB, CI18KB, CI18Y7, CI1E36, CI1JCE
Distribution pattern: US Nationwide distribution including the states of MA, TX, RI, OH, NY, MN, SD, IL, MO, FL, VA, NE, UT, CA
Derived failure modes
-
Labeling or packaging
Incomplete packaging