Medline Convenience Kits Recalled Due to Weak Packaging Seals
Medline is recalling Convenience kits due to open or weak seals on breather pouches used in sterile packaging. The recalled lot 24KBI045 was distributed nationwide and internationally.
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 affecting sterile medical equipment used in clinical procedures. While no illnesses or injuries have been reported, the potential for microbial contamination due to compromised seals on sterile packaging presents a genuine risk of harm.
Plain-English summary
Medline Industries, LP is recalling Convenience kits used for various procedures, including the Intubation Tray Model MNS10395. The recall affects 36 units that were distributed worldwide, including nationwide in the United States and internationally to Canada, Mexico, Panama, and the Virgin Islands.
The recall was initiated due to a potential for open or weak seals on breather pouches used to package these sterile convenience kits. Compromised seals could affect product sterility and potentially compromise the safety of the medical equipment.
Consumers and healthcare providers who have received these products should verify lot number 24KBI045 and discontinue use if the product matches this lot. Individuals with questions or concerns about this recall should contact Medline Industries.
The recalled product
- Product
- Medline Convenience kits used for various procedures: 1) INTUBATION TRAY, Model Number: MNS10395;
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Category
- Medical Device — Procedure Kits
- Hazard
- weak-seals
- 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) MNS10395
- UDI-DI: 10653160990185(each)
- 40653160990186(case)
- Lot Number: 24KBI045
Distribution
Distributed nationwide across the United States.
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