Medline umbilical catheter tray recalled for outer packaging defect
Medline is recalling its UMBILICAL TRAY W/3.5&5FR CATH due to a possible packaging defect in the outer Tyvek pouch. The defect could compromise the sterile protection of the product.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is a Class II recall of a risk-of-harm product (umbilical catheters for use on newborns) where a packaging defect could compromise sterile protection. No illnesses or injuries have been reported, which per the rubric caps the score at High (3).
Plain-English summary
Medline Industries, LP is recalling the UMBILICAL TRAY W/3.5&5FR CATH (Reference UVT1250) due to a possible packaging defect in the outer Tyvek pouch that protects the sterile product.
The defect could compromise the sterile barrier of the umbilical catheter tray. The recall involves 174 units with the following lot numbers: 25BBG881, 24KBU973, 24IBK851, and 24HBQ012. The affected products were distributed in Virginia. The product can be identified by UDI-DI 10653160995340 (individual unit) or UDI 40653160995341 (case).
No illnesses or injuries have been reported in connection with this packaging defect.
The recalled product
- Product
- Medline UMBILICAL TRAY W/3.5&5FR CATH, REF UVT1250
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Hazard
- packaging-defect
- sterile-barrier-compromise
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (6)
- UDI-DI: 10653160995340 (each)
- 40653160995341 (case)
- Lot Numbers: 25BBG881
- 24KBU973
- 24IBK851
- 24HBQ012
Distribution
Distributed nationwide across the United States.
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