Medline sterile convenience kits recalled for potentially weak packaging seals
Medline is recalling three sterile convenience kit models due to potentially open or weak seals on the breather pouches used for packaging. The affected kits are distributed worldwide, including the US, Canada, Mexico, Panama, and the Virgin Islands.
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 an FDA Class II recall for sterile medical device kits where compromised packaging seals could allow microbial contamination. Although no illnesses have been reported, the potential for pathogenic contamination of sterile kits presents a risk of harm that meets the High severity threshold.
Plain-English summary
Medline Industries, LP is recalling 2,118 units of three sterile convenience kit models: ANGIO CONSOLIDATED PACK (Model DYNJHTCAD1, Lot 24JBS743), ANGIOGRAPHY TRAY-LF (Model DYNJ05350V, Lot 24JBU500), and ANGIOGRAPHY PACK (Model DYNJ38144C, Lot 24KBD294). These kits are used for various medical procedures.
The issue is a potential for open or weak seals on the breather pouches used to package these sterile kits. Breather pouches are designed to maintain sterility while allowing gas exchange. Compromised seals could allow microbial contamination of the sterile contents.
These kits have been distributed worldwide, including to US facilities and international locations in Canada, Mexico, Panama, and the Virgin Islands. Customers who have received affected units should contact Medline Industries for instructions on handling the recalled products.
The recalled product
- Product
- Medline Convenience kits used for various procedures: 1) ANGIO CONSOLIDATED PACK, Model Number: DYNJHTCAD1; 2) ANGIOGRAPHY TRAY-LF, Model Number: DYNJ05350V; 3) ANGIOGRAPHY PACK, Model Number: DYNJ38144C
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Hazard
- weak-seal
- sterility-compromise
- microbial-contamination
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 (12)
- 1) DYNJHTCAD1
- UDI-DI: 10888277087583(each)
- 40888277087584(case)
- Lot Number: 24JBS743
- 2) DYNJ05350V
- UDI-DI: 10193489316629(each)
- 40193489316620(case)
- Lot Number: 24JBU500
- 3) DYNJ38144C
- UDI-DI: 10193489854916(each)
- 40193489854917(case)
- Lot Number: 24KBD294
Distribution
Distributed nationwide across the United States.
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