Z-1075-2023 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
- 48 cases (96 units)
Product Description
Sterile Procedural Trays, labeled as the following: GENERAL ENDOSCOPY
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
Item Number: DYNJ903826D, Case UDI/GTIN: 40195327177790, Unit UDI/GTIN: 10195327177799, Lot Number: 22IBR004;