Device product
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.
Z-0793-2025
Product summary
- Event
- Event 95852
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 182 units
- Official record key
device-enforcement:Z-0793-2025
Official wording
Reason: Custom convenience kits are being recall because the contain non-sterile Codman Surgical Patties & Surgical Strips, which have the potential for endotoxin contamination.
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.
Distribution pattern: Worldwide distribution - US Nationwide and the countries of UAE, and Canada.
Derived failure modes
-
Unknown
Custom convenience kits are being recall because the contain non-sterile Codman Surgical Patties & Surgical Strips, which have the potential for endotoxin contamination.