Medline Intubation Tray Convenience Kits Recalled for Weak Breather Pouch Seals
Medline Industries is recalling select Intubation Tray convenience kits (Model MNS10395, Lot 24KBI045) due to potential open or weak seals on breather pouches used for packaging. 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 of sterile medical kits. The hazard—compromised packaging seals that could allow contamination of sterile contents—represents a risk of harm (potential infection or unsuitable product use) without any reported illnesses or injuries documented in the source text, warranting a score of 3 per the rubric.
Plain-English summary
Medline Industries, LP is recalling select Intubation Tray convenience kits, Model Number MNS10395, due to a potential for open or weak seals on purchased breather pouches used for packaging these sterile medical kits.
The affected product includes Lot Number 24KBI045. The kits have been distributed worldwide, including throughout the United States and to Canada, Mexico, Panama, and the Virgin Islands.
Breather pouches with compromised seals may allow the sterile contents of the kits to become contaminated or non-sterile prior to use. Healthcare providers and facilities that have received these kits should verify the integrity of the breather pouch seals before use and contact Medline for guidance on affected units.
The recalled product
- Product
- Medline Convenience kits used for various procedures: 1) INTUBATION TRAY, Model Number: MNS10395;
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Hazard
- seal-integrity
- 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) MNS10395
- UDI-DI: 10653160990185(each)
- 40653160990186(case)
- Lot Number: 24KBI045
Distribution
Distributed nationwide across the United States.
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