Device product
Custom medical procedure packs labeled as: a) PELVIC EXAM TRAY, REF 89-6219
Z-2089-2023
Product summary
- Event
- Event 92445
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 3 packs
- Official record key
device-enforcement:Z-2089-2023
Official wording
Reason: The outer package seal could be open, or compromised which affects the sterility of the procedure pack inside.
Code information: a) REF 89-6219, GTIN 50749756664382 (cs), 00749756664387 (unit), Lot Numbers: 58807114
Distribution pattern: US Nationwide distribution.
Derived failure modes
-
Labeling or packaging
package seal could be open, or compromised
-
Sterility assurance
package seal could be open, or compromised which affects the sterility