FDA Medical devices recall ·
Medline procedure kits labeled as: 1) EYE PACK, Pack Number VAL038BSCLC recall
- Recall number
- Z-1394-2025
- Date
- (initiated February 11, 2025)
- Company / brand
- Medline Industries, LP
3 Lakes Dr, Northfield, IL, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 880 units
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
Medline procedure kits labeled as: 1) EYE PACK, Pack Number VAL038BSCLC
Why was it recalled?
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/other quality issues have been identified that may pose a risk to patient health.
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
1) 10193489244441 (each) 40195327273133 (case), Lot Number 40193489244442
Distribution
Worldwide - US Nationwide and the country of 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-1394-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.