Medline custom surgical procedure kits recalled for non-sterile components and endotoxin contamination
Medline custom procedure kits containing non-sterile Codman Surgical Patties & Strips are being recalled due to potential endotoxin contamination. The recall affects 74 units 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 recall for non-sterile surgical supplies with potential endotoxin contamination. No illnesses or injuries are reported in the source, making this a risk-of-harm product without documented injury, which qualifies as High per the severity rubric.
Plain-English summary
Medline Industries is recalling custom medical procedure kits labeled as UMC DR. BAKER SUPPLEMENT (REF DYNJ69476) and DIEP FLAP (REF DYNJ910120) because they contain non-sterile Codman Surgical Patties and Surgical Strips with the potential for endotoxin contamination. A total of 74 units have been recalled.
The affected products have been distributed worldwide, including throughout the United States, the United Arab Emirates, and Canada. The affected lot numbers are 21HDB296 for the UMC DR. BAKER SUPPLEMENT (REF DYNJ69476) and 24CMH776 for the DIEP FLAP (REF DYNJ910120).
The recalled product
- Product
- Medline custom medical procedure kits labeled as: 1) UMC DR. BAKER SUPPLEMENT, REF DYNJ69476; 2) DIEP FLAP, REF DYNJ910120
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Hazard
- non-sterile
- endotoxin-contamination
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 (6)
- 1) REF DYNJ69476
- UDI/DI 10193489947786 (EA) 40193489947787 (CS)
- Lot Numbers: 21HDB296
- 2) REF DYNJ910120
- UDI/DI 10195327589202 (EA) 40195327589203 (CS)
- Lot Numbers: 24CMH776.
Distribution
Distributed nationwide across the United States.
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