FDA Medical devices recall ·
MAJOR NEURO PACK-LF Convenience kit, SKU DYNJ0578916X… recall
- Recall number
- Z-0717-2025
- Date
- (initiated November 6, 2024)
- Company / brand
- Medline Industries, LP
3 Lakes Dr, Northfield, IL, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 40 kits
- Hazard tags
- Sterility
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
MAJOR NEURO PACK-LF Convenience kit, SKU DYNJ0578916X. Convenience kits used for various procedures.
Why was it 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 you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
UDI-DI: 10193489288384 (each), 40193489288385 (case); Lot Number: 23AMD730
Distribution
US Nationwide. Canada.
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-0717-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.