FDAClass IIJanuary 1, 2025

KIT,SPINE LH Convenience kit recall: Endotoxin

KIT,SPINE LH Convenience kit, SKU DYNJ906448A.

Why was KIT,SPINE LH Convenience kit recalled?

Surgical Patties & Surgical Strips in specific lots of Custom Convenience Kits were found to contain higher-than-expected levels of endotoxin within the raw material used to produce sterile Codman Surgical Patties and Strips that may have resulted in out-of-specification levels of endotoxin in those finished goods

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

UDI-DI: 10193489408508(each), 40193489408509(case); Lot Number: 21EBG271 21CBS664 20LBO883 20WBE707

Product
KIT,SPINE LH Convenience kit, SKU DYNJ906448A.
Recalling firm
MEDLINE INDUSTRIES, LP - Northfield
Quantity
160 kits
Distribution
US Nationwide. Canada.
Recall date
January 1, 2025
Classification
Class II
Status
Ongoing
Agency
FDA (device)
Open FDA enforcement record Latest recalls