Device product
Custom medical procedure packs labeled as: a) STURDI STRAINER TRAY STANDARD, REF '89-5014
Z-2087-2023
Product summary
- Event
- Event 92445
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 40 units
- Official record key
device-enforcement:Z-2087-2023
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 '89-5014, GTIN 50749756217908 (cs), 00749756217903 (unit), , Lot Numbers: 58770294
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