Surgical Patties and Strips Recalled for Endotoxin Contamination
Medline Industries recalls DIEP FLAP Convenience kits containing surgical patties and strips due to higher-than-expected endotoxin contamination that may not meet sterile product specifications.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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: FDA Class II medical device recall involving endotoxin contamination in sterile surgical products. This represents a risk-of-harm product where injury has not yet been reported, matching the rubric criterion for High severity.
Plain-English summary
Medline Industries, LP has recalled DIEP FLAP Convenience kits (SKU DYNJ910120) due to contamination in the Codman Surgical Patties and Strips contained in specific lots of the kits. These sterile surgical supplies are used in various medical procedures.
The recall was issued because the surgical patties and strips were found to contain higher-than-expected levels of endotoxin in the raw materials used to manufacture them. This contamination resulted in finished products with out-of-specification endotoxin levels. Endotoxin is a bacterial component that can trigger adverse reactions if present in sterile surgical materials.
The affected lot number is 24CMH776, with 26 kits distributed nationwide in the United States and Canada. Healthcare facilities and medical centers that received kits from this lot should identify and remove them from use.
If you have received or used kits from lot 24CMH776, contact Medline Industries for further instructions. Consult with your healthcare provider if you have questions or concerns about any procedures where these kits may have been used.
The recalled product
- Product
- DIEP FLAP Convenience kit, SKU DYNJ910120. Convenience kits used for various procedures.
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Hazard
- Affected units
- 26
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 (3)
- UDI-DI: 10195327589202(each)
- 40195327589203(case)
- Lot Number: 24CMH776
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 10 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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