FDA Medical devices recall ·
namic convenience kits labeled as: PML,72,ADULT,FLL-MLL,-,OEM recall
- Recall number
- Z-1428-2025
- Date
- (initiated February 12, 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
- 4400 units
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
namic convenience kits labeled as: PML,72,ADULT,FLL-MLL,-,OEM, REF 80641722; medical convenience kit
Why was it recalled?
The female luer fittings on the Pressure Monitoring Lines (PMLs) were manufactured with excess material near the fluid pathway.
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 10193489067507 (each), 20193489067504 (case), Lot number 0000140528
Distribution
Worldwide distribution - US Nationwide and the countries of The Netherlands, New Zealand, Slovakia
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-1428-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.