Surgical Patties and Strips Recalled for Endotoxin Contamination
Medline Industries recalls specific lots of surgical patties and strips in MAJOR NEURO PACK-LF Convenience kits due to higher-than-expected endotoxin levels detected in raw materials, which may have resulted in out-of-specification finished products.
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 sterile product contamination with endotoxin in surgical materials. Although no illnesses or hospitalizations have been reported, endotoxin contamination in sterile surgical products poses a significant risk of harm during procedures, qualifying as a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Medline Industries is recalling specific lots of MAJOR NEURO PACK-LF Convenience kits containing surgical patties and surgical strips due to contamination concerns in the manufacturing process.
The raw materials used to produce these sterile surgical products were found to contain higher-than-expected levels of endotoxin, which may have resulted in out-of-specification endotoxin levels in the finished goods. Endotoxin is a bacterial component that can trigger pyrogenic reactions and inflammatory responses.
The affected products were distributed nationwide in the United States and Canada. The recall involves lot number 23AMD730. Product identifiers include UDI-DI 10193489288384 (individual kits) and 10193489288385 (case packs).
Healthcare facilities and medical professionals should stop using the affected products immediately. Individuals with questions about whether their products are affected should contact Medline Industries for lot verification and guidance on replacement or return.
The recalled product
- Product
- MAJOR NEURO PACK-LF Convenience kit, SKU DYNJ0578916X. Convenience kits used for various procedures.
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Hazard
- Affected units
- 40
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: 10193489288384 (each)
- 40193489288385 (case)
- Lot Number: 23AMD730
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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