Z-0718-2025 Class II Ongoing
FDA device recall Z-0718-2025 was initiated by MEDLINE INDUSTRIES, LP - Northfield on Nov 6, 2024 and is designated Class II. 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… The recall status is ongoing. Affected quantity: 36 kits.
Recall Details
- Product Type
- Devices
- Report Date
- Jan 1, 2025
- Initiation Date
- Nov 6, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 36 kits
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
Distribution Pattern
US Nationwide. Canada.
Code Information
UDI-DI: 10195327050146(each), 40195327050147(case); Lot Number: 23HMB316
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0718-2025
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 25, 2026