FDA Medical devices recall ·
Medline UMBILICAL TRAY W/3.5&5FR CATH recall
- Recall number
- Z-1995-2025
- Date
- (initiated May 15, 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
- 174 units
- Hazard tags
- Sterility
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
Medline UMBILICAL TRAY W/3.5&5FR CATH, REF UVT1250
Why was it recalled?
There is a possible packaging defect impacting the outer Tyvec pouch that protects the sterile product.
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: 10653160995340 (each), 40653160995341 (case); Lot Numbers: 25BBG881, 24KBU973, 24IBK851, 24HBQ012
Distribution
US Nationwide distribution in the state of VA.
States: Virginia
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-1995-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.