Device product
Medline custom medical procedure kits labeled as: 1) PANENDOSCOPY-LF, REF DYNJ36728C; 2) ENDOSCOPIC SINUS PACK, REF DYNJ40644A; 3) ENDO SINUS PACK, REF DYNJ66449.
Z-0785-2025
Product summary
- Event
- Event 95852
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 1086 units
- Official record key
device-enforcement:Z-0785-2025
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 DYNJ36728C, UDI/DI 10193489265910(EA) (CS), Lot Numbers: 20EBK304, 20HBL260, 20LBA831, 20WBG513, 21DBK481, 21KBO816, 22BBJ543, 22FBD924, 22HBR956, 22KBJ095, 23BBF230, 23FBG752, 23HBI340, 23IBD038, 24CBG736, 24GBJ933; 2) REF DYNJ40644A, UDI/DI 10193489292176(EA) (CS), Lot Numbers: 20CMB952, 20HMB559, 20KMA468, 20KMB182, 20KMC866, 21AME524, 21DMA759, 21EME248, 21GMB592, 21HMC615, 21IMF418, 21JMA505, 21KMG859, 21LMF984; 3) REF DYNJ66449, UDI/DI 10193489356113(EA) (CS), Lot Numbers: 20EBN857, 20HBH423, 20HBN194.
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.