Medline Surgical Procedure Kits Recalled for Endotoxin Contamination Risk
Medline Industries is recalling 2344 custom surgical kits with non-sterile components that may contain endotoxins. The kits were distributed in the US, UAE, and Canada.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II device recall involving non-sterile surgical components with potential endotoxin contamination in critical-use medical devices. No illnesses or injuries are reported in the source, making this a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Medline Industries, LP is recalling 2344 units of custom surgical procedure kits containing non-sterile Codman Surgical Patties and Surgical Strips that have the potential for endotoxin contamination. The recall includes seven different kit configurations, each identified by specific reference numbers and lot codes.
The affected kits were distributed nationwide in the United States and internationally to the United Arab Emirates and Canada. Detailed information about the affected kit types, reference numbers, and lot codes is available from the FDA recall notice.
The recalled product
- Product
- 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, REFDY
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Category
- Medical Device — Surgical Kits
- Affected units
- 2,344
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- 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
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 18 recalled by MEDLINE INDUSTRIES, LP - Northfield under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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