Z-1081-2023 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- February 15, 2023
- Initiation Date
- November 17, 2022
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 36 cases (116 units)
Product Description
Sterile Procedural Trays, labeled as the following: a. WOUND CLOSURE TRAY b. WOUND PACK
Reason for Recall
Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging.
Distribution Pattern
Worldwide distribution - US Nationwide and the countries of Canada, Japan, Mexico, Panama, Turks & Caicos, United Arab Emirates.
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