Z-0793-2025 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
- 182 units
Product Description
Medline custom medical procedure kits labeled as: 1) CERVICAL PACK-LF, REF DYNJ0867145G; 2) CERVICAL SPINE PACK HUM-LF, REF DYNJ35184F; 3) ANTERIOR CERVICAL-CORPECTOMY, REF DYNJ904827.
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 DYNJ0867145G, UDI/DI 10889942625413 (EA) 40889942625414 (CS), Lot Numbers: 19BDA435, 19DDD135; 2) REF DYNJ35184F, UDI/DI 10889942567737 (EA) 40889942567738 (CS), Lot Numbers: 19CBC965, 19QBC217; 3) REF DYNJ904827, UDI/DI 10889942743742 (EA) 40889942743743 (CS), Lot Numbers: 19DBD844, 19HBO089, 19HBQ573, 19IBQ930, 19SBE329.