Procedural trays recalled for potential sterile packaging breach
Medline Industries recalls non-sterile procedural trays (LAPAROTOMY CDS) because sterile blades within the kits may puncture the outer foil packaging, compromising sterility.
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 FDA Class II medical device recall involves a confirmed risk-of-harm product (surgical instruments) where a potential packaging breach could compromise sterility. No illnesses or injuries have been reported, which meets the rubric criterion for score 3: risk-of-harm products where injury has not yet been reported.
Plain-English summary
Medline Industries, LP is recalling 57 cases (114 units) of non-sterile procedural trays labeled as LAPAROTOMY CDS, Item Number CDS980894A. The U.S. Food and Drug Administration classified this as a Class II medical device recall.
The procedural trays contain sterile blades that may puncture the outer foil layer of the packaging, potentially compromising the sterile integrity of the contents. This packaging breach could lead to contamination of the surgical instruments.
The affected products were distributed nationwide in Arkansas, Maryland, Washington, and Wisconsin. The affected lot numbers are 22HMD613 and 22JMB665.
Consumers and healthcare facilities who have received these products should discontinue use and contact Medline Industries for instructions regarding return or replacement of the affected trays. For more information, refer to FDA recall number Z-1031-2023.
The recalled product
- Product
- Non-sterile procedural trays labeled as LAPAROTOMY CDS, 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 (5)
- Item Number: CDS980894A
- UDI/GTIN Case: 40889942401292
- UDI/GTIN Each: 10889942401291
- Lot Numbers: 22HMD613
- 22JMB665
Distribution
Distributed nationwide across the United States.
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