Medline custom surgical procedure kits recalled for non-sterile components
Medline is recalling 182 custom surgical procedure kits containing non-sterile Codman Surgical Patties and Strips with potential endotoxin contamination. 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: The recall involves non-sterile surgical supplies with potential endotoxin contamination—a risk-of-harm situation in an invasive procedure context. No illnesses or injuries have been reported. Although classified as FDA Class II, the absence of reported hospitalizations places this below the Severe threshold, but the serious contamination risk justifies High severity.
Plain-English summary
Medline Industries is recalling 182 custom medical procedure kits designed for cervical spine surgery. The affected products are labeled as CERVICAL PACK-LF (REF DYNJ0867145G), CERVICAL SPINE PACK HUM-LF (REF DYNJ35184F), and ANTERIOR CERVICAL-CORPECTOMY (REF DYNJ904827).
The kits are being recalled because they contain non-sterile Codman Surgical Patties and Surgical Strips that have the potential for endotoxin contamination.
The affected kits were distributed worldwide, including throughout the United States, the United Arab Emirates, and Canada.
The recalled product
- Product
- Medline custom medical procedure kits labeled as: 1) CERVICAL PACK-LF, REF DYNJ0867145G; 2) CERVICAL SPINE PACK HUM-LF, REF DYNJ35184F; 3) ANTERIOR CERVICAL-CORPECTOMY, REF DYNJ904827.
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Hazard
- endotoxin
- non-sterile
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 (15)
- 1) REF DYNJ0867145G
- UDI/DI 10889942625413 (EA) 40889942625414 (CS)
- Lot Numbers: 19BDA435
- 19DDD135
- 2) REF DYNJ35184F
- UDI/DI 10889942567737 (EA) 40889942567738 (CS)
- Lot Numbers: 19CBC965
- 19QBC217
- 3) REF DYNJ904827
- UDI/DI 10889942743742 (EA) 40889942743743 (CS)
- Lot Numbers: 19DBD844
- 19HBO089
- 19HBQ573
- 19IBQ930
- 19SBE329.
Distribution
Distributed nationwide across the United States.
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