Device product
Medline Tissue Recovery Instrument Set, Reorder #DYNJ64347A, packaged 3/case, Sterile, Rx. Convenience kit used to recover tissue, which can be used for medical research, education, or transplantation.
Z-1841-2021
Product summary
- Event
- Event 87910
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 36/3-kit cases (108 kits)
- Official record key
device-enforcement:Z-1841-2021
Official wording
Reason: The devices may not meet the minimum required sterility assurance level.
Code information: GTIN (01)10193489291186, lot numbers 21CDA959, 21BDB665, 21ADA390, and 20KDC285
Distribution pattern: US Distribution to state of: WI.
Derived failure modes
-
Unknown
The devices may not meet the minimum required sterility assurance level.