Device product
Non-sterile procedural trays labeled as LAPAROSCOPIC, 2 per case
Z-1030-2023
Product summary
- Event
- Event 91387
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 260 cases (520 units)
- Official record key
device-enforcement:Z-1030-2023
Official wording
Reason: Potential for sterile blades, within non-sterile SPT kits containing the blades, to puncture the outer foil layer causing a breach in the sterile packaging.
Code information: Item Number: DYNJ900415L, UDI/GTIN Case: 40195327029426, UDI/GTIN Each: 10195327029425, Lot Numbers: 22HBO658, 22JBV699
Distribution pattern: US Nationwide distribution in the states of AR, MD, WA, WI.
Derived failure modes
-
Unknown
Potential for sterile blades, within non-sterile SPT kits containing the blades, to puncture the outer foil layer causing a breach in the sterile packaging.