Class II
Medical Device Recall: Medline brand, medical procedure convenience kits, labeled as: 1) MVFF/FIBU #54-RF , SKU DYNJ21927R; 2) DIEP FLAP, SKU DYNJ910120A
MEDLINE INDUSTRIES, LP - Northfield · November 6, 2024
Reason for Recall
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
Distribution
US Nationwide. Canada.
States Affected
NATIONWIDE
Quantity Affected
318 kits
Source: FDA (openFDA Device Enforcement)
Recall number: Z-0721-2025
Status: ongoing
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