Medline custom medical procedure kits labeled as: 1) OPEN HEART CDS-LF, REFCDS840451M; 2) NEURO PACK, REFDYNJ41516M; 3) RFD- AAA PACK, REFDYNJ54242B; 4) OPEN HEART A&B, REFDYNJ901203C; 5) OPEN HEART A&B, REFDYNJ901203D; 6) ACDF-LF, REFDYNJ906681B; 7) ACDF-LF, REFDYNJ906681C.
This recall is currently active, issued December 30, 2024. It was issued by Medline Industries, Lp - Northfield.
- Recall Initiated
- November 21, 2024
- Posted
- December 30, 2024
- Recall Number
- Z-0778-2025
- Quantity
- 2344 units
- Firm Location
- Northfield, IL
- Official Source
- View on FDA website ↗
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
Worldwide distribution - US Nationwide and the countries of UAE, and Canada.
Lot / Code Info
1) REF CDS840451M, UDI/DI 10195327417574 (EA) 40195327417575 (CS), Lot Numbers: 24BLA736; 2) REF DYNJ41516M, UDI/DI 10193489202564 (EA) 40193489202565 (CS), Lot Numbers: 19JKB417, 19LKA454, 20AKB109, 20DKB147, 20FKB171; 3) REF DYNJ54242B, UDI/DI 10195327167097 (EA) 40195327167098 (CS), Lot Numbers: 23GBO400; 4) REF DYNJ901203C, UDI/DI 10889942572526 (EA) 40889942572527 (CS), Lot numbers: 19BKA270, 19CKC053, 19EKD526, 19FKC478, 19HKA796, 19KKA783, 19LKB868, 20BKA558, 20FKA993, 20IKA397, 20LKA831, 21BKA583, 21DKA592, 21GMB734; 5) REF DYNJ901203D, UDI/DI 10193489947526 (EA) 40193489947527 (CS), Lot Numbers: 21GME287, 21JMH613, 22AMB438, 22CMD928, 22CMF425, 22EMF242, 22FMG716, 22GMH022, 22IMD195, 23AMB881, 23DME044, 23DME245, 23EMI884, 23HMH269, 23HMI447, 23LMB223, 24AMB281, 24CMI324, 24EMC691, 24EMI830; 6) REF DYNJ906681B, UDI/DI 10195327106881 (EA) 40195327106882 (CS), Lot Numbers: 22FBC663, 22OBM278; 7) REF DYNJ906681C, UDI/DI 10195327173838 (EA) 40195327173839 (CS) , Lot Numbers: 22IBR002, 22JBV571, 22JBW937, 22KBB923, 22LBK562, 23ABC493, 23GBR644, 23IBP138, 23IBV201, 23JBK264, 23LBE604, 23LBS964, 24CBP708, 24EBA703, 24GBL458.
Root Cause
Nonconforming Material/Component
Action Taken
Medline issued a MEDICAL DEVICE VOLUNTARY RECALL notice on 11/21/2024 to its consignees via US Mail and email. The notice explained the issue, potential risk to health, and requested that the affected product be quarantined. Once the response is received, Medline will provide labels to place on affected inventory, with instructions for the consignee to remove the affected component prior to using the kit.