Medline Convenience Kits Recalled for Potential Open or Weak Seals
Medline Industries is recalling select sterile convenience kits due to potential open or weak seals on breather pouches used for packaging. The defect may compromise product 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 is an FDA Class II recall for a sterile medical device with a defect that could compromise sterility and create risk of harm (potential contamination or use of non-sterile devices). No illnesses or injuries have been reported, but the potential for patient harm is present.
Plain-English summary
Medline Industries, LP is recalling select sterile convenience kits, including the CUSTOM BLOCK KEMP PACK-LF (Model Number DYNJ0371999G, Lot Number 24KBE129), due to a potential for open or weak seals on breather pouches used for packaging.
The defect may compromise the sterility of the kits. Open or weak seals could allow contamination or loss of sterile conditions during storage and transport.
The affected product was distributed worldwide, including the United States, Canada, Mexico, Panama, and the US Virgin Islands.
Customers who have purchased these kits should contact Medline Industries for further instructions regarding the affected units.
The recalled product
- Product
- Medline Convenience kits used for various procedures: 1) CUSTOM BLOCK KEMP PACK-LF, Model Number: DYNJ0371999G;
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Hazard
- seal-defect
- sterility-compromise
- 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)
- 1) DYNJ0371999G
- UDI-DI: 10889942061037(each)
- 40889942061038(case)
- Lot Number: 24KBE129
Distribution
Distributed nationwide across the United States.
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