Medline Convenience Kits Recalled for Potential Open Breather Pouch Seals
Medline Industries is recalling select sterile convenience kits (Model DYNJ80807B, Lot 24IBH993) due to potential open or weak seals on breather pouches used for packaging. Compromised seals may affect 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: FDA Class II recall of sterile medical devices with a contamination/integrity risk (open/weak seals on sterile packaging). The source text does not report any illnesses or injuries, so the hazard is potential rather than confirmed; however, the integrity of sterile medical device packaging represents a risk of harm that justifies a score of 3.
Plain-English summary
Medline Industries, LP is recalling Medline Convenience kits, specifically the CW PERI GYN model (Model Number DYNJ80807B, Lot Number 24IBH993), due to a potential for open or weak seals on breather pouches used for packaging these sterile medical kits.
The affected kits have been distributed worldwide, including nationwide in the United States and internationally to Canada, Mexico, Panama, and the Virgin Islands. The product is identified by UDI-DI 10195327415624 (each) and 40195327415625 (case).
Consumers and healthcare facilities in possession of affected kits should stop using them and contact Medline Industries for instructions on return or replacement. Open or weak seals on sterile packaging may compromise the sterility of the medical devices contained within.
The recalled product
- Product
- Medline Convenience kits used for various procedures: 1) CW PERI GYN, Model Number: DYNJ80807B
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Hazard
- defective-seal
- sterility-compromise
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) DYNJ80807B
- UDI-DI: 10195327415624(each)
- 40195327415625(case)
- Lot Number: 24IBH993
Distribution
Distributed nationwide across the United States.
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