Surgical Patties and Strips with Endotoxin Contamination in Medline Convenience Kits
Medline Industries is recalling surgical patties and strips in specific lots of KIT,SPINE LH Convenience Kits due to higher-than-expected endotoxin levels in raw materials. The contamination may result in out-of-specification endotoxin in finished sterile 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: This is an FDA Class II medical device recall involving endotoxin, a high-risk bacterial contaminant, in sterile surgical products. No illnesses or injuries have been reported. The contamination presents a significant risk of harm if the products are used in sterile surgical procedures.
Plain-English summary
Medline Industries, LP is recalling KIT,SPINE LH Convenience Kits (SKU DYNJ906448A) in specific lots due to endotoxin contamination. The affected lots are: 21EBG271, 21CBS664, 20LBO883, and 20WBE707. The kits contain surgical patties and surgical strips.
The recalled products were found to contain higher-than-expected levels of endotoxin in the raw materials used to manufacture the sterile surgical patties and strips. This contamination may have resulted in out-of-specification endotoxin levels in the finished surgical products.
The affected kits were distributed nationwide in the United States and in Canada. Endotoxin is a bacterial contaminant that can cause fever and systemic inflammatory reactions if introduced into sterile surgical sites. Healthcare facilities and surgical centers that received these products in the specific lot numbers should stop using them and contact Medline Industries for instructions on returns or replacement.
The recalled product
- Product
- KIT,SPINE LH Convenience kit, SKU DYNJ906448A.
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Affected units
- 160
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: 10193489408508(each)
- 40193489408509(case)
- Lot Number: 21EBG271 21CBS664 20LBO883 20WBE707
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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