Z-0780-2025 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- January 8, 2025
- Initiation Date
- November 21, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 74 units
Product Description
Medline custom medical procedure kits labeled as: 1) UMC DR. BAKER SUPPLEMENT, REF DYNJ69476; 2) DIEP FLAP, REF DYNJ910120
Reason for Recall
Custom convenience kits are being recall because the contain non-sterile Codman Surgical Patties & Surgical Strips, which have the potential for endotoxin contamination.
Distribution Pattern
Worldwide distribution - US Nationwide and the countries of UAE, and Canada.
Code Information
1) REF DYNJ69476, UDI/DI 10193489947786 (EA) 40193489947787 (CS), Lot Numbers: 21HDB296; 2) REF DYNJ910120, UDI/DI 10195327589202 (EA) 40195327589203 (CS), Lot Numbers: 24CMH776.