MEDLINE procedural trays recalled for potential sterile packaging breach
MEDLINE is recalling procedural trays because sterile blades within the kits could puncture the outer foil packaging, potentially breaching the sterile barrier.
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 medical device recall involving a risk-of-harm product where injury has not yet been reported. The potential for compromised sterile packaging in medical devices presents a theoretical but significant contamination risk during procedures, warranting a High severity classification per the rubric.
Plain-English summary
MEDLINE INDUSTRIES, LP is recalling non-sterile procedural trays labeled as CRANI (Item Number DYNJ900413P, Lot Number 22JDB689). The recall affects 12 cases containing 24 units distributed nationwide in Arkansas, Maryland, Washington, and Wisconsin.
The recalled kits contain sterile blades that could potentially puncture the outer foil packaging, causing a breach in the sterile barrier. The FDA classified this as a Class II recall.
The recalled product
- Product
- Non-sterile procedural trays labeled as CRANI, 2 per case
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Hazard
- sterile-packaging-breach
- contamination-risk
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 (4)
- Item Number: DYNJ900413P
- UDI/GTIN Case: 40195327031665
- UDI/GTIN Each: 40195327031665
- Lot Number: 22JDB689
Distribution
Distributed nationwide across the United States.
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