Medline Umbilical Tray sterile packaging defect recall
Medline is recalling umbilical trays due to a possible packaging defect in the outer Tyvec pouch that protects the sterile product. The defect may compromise sterility.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is an FDA Class II recall. The source text identifies only a possible packaging defect with no reported illnesses or injuries, making it a precautionary recall that does not rise to the level of High severity.
Plain-English summary
Medline Industries, LP is recalling the Medline UMBILICAL TRAY W/3.5&5FR CATH (Reference UVT1250) due to a possible packaging defect impacting the outer Tyvec pouch that protects the sterile product.
The packaging defect may compromise the sterility of the medical device. A total of 174 units have been recalled.
The affected product was distributed nationwide in Virginia. Lot numbers 25BBG881, 24KBU973, 24IBK851, and 24HBQ012 are included in this recall.
Consumers in possession of this product should stop using it and contact Medline Industries or their healthcare provider for further instructions.
The recalled product
- Product
- Medline UMBILICAL TRAY W/3.5&5FR CATH, REF UVT1250
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Affected units
- 174
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
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