Device product
Medline SYRINGE, PISTON,IRR TRAY,W/.9, REF DYNC2303. Sterile Piston Irrigation Syringe Tray with Saline
Z-2358-2019
Product summary
- Event
- Event 83551
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 11962 trays
- Official record key
device-enforcement:Z-2358-2019
Official wording
Reason: Samples in the identified lot were found to have incomplete or open packaging seals.
Code information: Lot Number 19CAB954
Distribution pattern: US nationwide distribution
Derived failure modes
-
Labeling or packaging
open packaging