Z-1076-2023 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
- 20 cases (72 units)
Product Description
Sterile Procedural Trays, labeled as the following: a. ENDOSCOPY-LF b. SEPTO/ENDO
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. ENDOSCOPY-LF, Item Number: DYNJ22890M, Case UDI/GTIN: 40193489766487, Unit UDI/GTIN: 10193489766486, Lot Number: 22JBM081; b. SEPTO/ENDO, Item Number: DYNJ902831D, Case UDI/GTIN: 40193489231671, Unit UDI/GTIN: 10193489231670, Lot Number: 22JBP701;