Recall Z-0718-2025— MEDLINE INDUSTRIES, LP - Northfield
Class II · Ongoing
Class II FDA medical device recall by MEDLINE INDUSTRIES, LP - Northfield, initiated 2024-11-06. FDA's recall record names no specific 510(k) clearance for this event. Product: FESS-MB PACK-LF Convenience kit, SKU DYNJ0888159I. Convenience kits used for various procedures... Reason: 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.
- Recalling firm
- MEDLINE INDUSTRIES, LP - Northfield
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2024-11-06
- Firm location
- Northfield, IL, United States
Product description
FESS-MB PACK-LF Convenience kit, SKU DYNJ0888159I. Convenience kits used for various procedures..
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
Data sourced from openFDA. This site is unofficial and independent of the FDA.