Z-1995-2025 Class II Ongoing
FDA device recall Z-1995-2025 was initiated by MEDLINE INDUSTRIES, LP - Northfield on May 15, 2025 and is designated Class II. Reason for recall: There is a possible packaging defect impacting the outer Tyvec pouch that protects the sterile product. The recall status is ongoing. Affected quantity: 174 units.
Recall Details
- Product Type
- Devices
- Report Date
- July 2, 2025
- Initiation Date
- May 15, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 174 units
Product Description
Medline UMBILICAL TRAY W/3.5&5FR CATH, REF UVT1250
Reason for Recall
There is a possible packaging defect impacting the outer Tyvec pouch that protects the sterile product.
Distribution Pattern
US Nationwide distribution in the state of VA.
Code Information
UDI-DI: 10653160995340 (each), 40653160995341 (case); Lot Numbers: 25BBG881, 24KBU973, 24IBK851, 24HBQ012