Medline Convenience Kit Drape Packs Recalled for Weak Seal Risk
Medline Industries is recalling UNIVERSAL DRAPE PACK convenience kits because their breather pouches may have open or weak seals, potentially compromising sterility of the packaged kits.
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 of sterile medical kits where a packaging defect (weak or open seals) creates a risk of loss of sterility, a serious risk of harm to patients. No illnesses or injuries are reported, but the hazard is not merely theoretical—compromised sterility of surgical kits poses direct patient risk.
Plain-English summary
Medline Industries, LP is recalling UNIVERSAL DRAPE PACK convenience kits (Model Number DYNJCD0239) due to a potential for open or weak seals on the breather pouches used to package these sterile kits. The affected lot is 24IBR482, consisting of 90 units distributed worldwide including the US, Canada, Mexico, Panama, and the US Virgin Islands.
Breather pouches with compromised seals may allow the packaged sterile kits to lose their sterile condition, which could affect their safety and effectiveness for use in various medical procedures.
Consumers and healthcare facilities that have received these kits should stop using them and contact Medline Industries for further instructions regarding return or replacement of the affected products.
The recalled product
- Product
- Medline Convenience kits used for various procedures: 1) UNIVERSAL DRAPE PACK, Model Number: DYNJCD0239
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Hazard
- sterility-compromise
- packaging-defect
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) DYNJCD0239
- UDI-DI: 10889942245901(each)
- 40889942245902(case)
- Lot Number: 24IBR482
Distribution
Distributed nationwide across the United States.
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