Medline Universal Drape Pack Medical Kits Recalled for Weak Sterile Seals
Medline is recalling Universal Drape Pack convenience kits due to potential open or weak seals on sterile packaging pouches. Weak seals 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 involving compromised sterile packaging on medical device convenience kits. The defect creates a risk-of-harm to patients through potential product contamination and infection, even though no illnesses or injuries have been reported to date.
Plain-English summary
Medline Industries, LP is recalling Medline Convenience kits, specifically the UNIVERSAL DRAPE PACK, Model Number DYNJCD0239, due to potential open or weak seals on purchased breather pouches used to package these sterile kits.
The weak or open seals on the sterile packaging pouches create a risk that the product may no longer maintain its sterile condition. Compromised sterility in surgical convenience kits could result in contamination and potential infection if the products are used.
The affected lot (24IBR482) was distributed worldwide, including throughout the United States, Canada, Mexico, Panama, and the Virgin Islands. A total of 90 units were involved in this recall.
Customers who have purchased these kits should discontinue use immediately and contact Medline Industries, LP or consult their healthcare provider for guidance on returning or replacing 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
- seal-defect
- 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 (4)
- 1) DYNJCD0239
- UDI-DI: 10889942245901(each)
- 40889942245902(case)
- Lot Number: 24IBR482
Distribution
Distributed nationwide across the United States.
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