Device product
Medline Arthroscopy Kit, convenience kit, REF DYNJ904304B, containing expired component NaCl 3000mL Irrigation Bag (exp. date 08/01/2020).
Z-2234-2021
Product summary
- Event
- Event 88268
- Status
- Terminated
- Classification
- Class II
- Quantity
- 286 total kits for all products
- Official record key
device-enforcement:Z-2234-2021
Official wording
Reason: The kits may contain an expired component.
Code information: Lot 19IBR389, Exp. 2020-09-30, GTIN (01)10889942833290.
Distribution pattern: US Nationwide distribution in the states of MN, NE, and PA.
Derived failure modes
-
Unknown
The kits may contain an expired component.