Device product
Sterile Procedural Trays, labeled as the following: a. WOUND CLOSURE TRAY b. WOUND PACK
Z-1081-2023
Product summary
- Event
- Event 91386
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 36 cases (116 units)
- Official record key
device-enforcement:Z-1081-2023
Official wording
Reason: Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging.
Code information: a. WOUND CLOSURE TRAY, Item Number: DYNJ56703, Case UDI/GTIN: 40889942672418, Unit UDI/GTIN: 10889942672417, Lot Number: 22JBE355; b. WOUND PACK, Item Number: DYNJ80201A, Case UDI/GTIN: 40195327171538, Unit UDI/GTIN: 10195327171537, Lot Number: 22IBE619
Distribution pattern: Worldwide distribution - US Nationwide and the countries of Canada, Japan, Mexico, Panama, Turks & Caicos, United Arab Emirates.
Derived failure modes
-
Unknown
Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging.