Z-1061-2023 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
- 28 cases (112 units)
Product Description
TRACH PACK. Sterile Procedural Tray.
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: DYNJ46518G, Case UDI/GTIN: 40195327009169, Unit UDI/GTIN: 10195327009168, Lot Number: 22JMB321, 22JMA904, 22HMD287