Class II

Medical Device Recall: MAJOR NEURO PACK-LF Convenience kit, SKU DYNJ0578916X. Convenience kits used for various procedures.

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

40 kits

Source: FDA (openFDA Device Enforcement)

Recall number: Z-0717-2025

Status: ongoing

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.