Device product
Medline custom medical procedure kits labeled as: 1) NASAL PACK, REF DYNJ67789A.
Z-0781-2025
Product summary
- Event
- Event 95852
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 80 units
- Official record key
device-enforcement:Z-0781-2025
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 DYNJ67789A, UDI/DI 10193489945645 (EA) 40193489945646 (CS), Lot Numbers: 21GBW066, 21JBK474, 21KBS434, 21KBX401
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.