Medline Sterile Convenience Kits Recalled for Potential Breather Pouch Seal Defects
Medline is recalling certain sterile convenience kits due to potential open or weak seals on breather pouches used for packaging. Compromised seals could allow contamination and compromise the sterility of the 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 for a risk-of-harm medical product with a potential packaging defect. The defect has not resulted in reported illnesses or injuries, and the hazard is theoretical rather than confirmed, placing it at the maximum score of 3 per the rubric.
Plain-English summary
Medline Industries, LP is recalling sterile convenience kits (Model DYNJ80807B, Lot 24IBH993) used for various medical procedures. The kits are affected by a potential defect in the packaging system.
The breather pouches used to package these sterile kits may have open or weak seals. Such defects could potentially allow contamination, compromising the sterility of the medical kits.
The affected products were distributed worldwide, including throughout the United States, Canada, Mexico, Panama, and the Virgin Islands. Approximately 48 units were distributed.
Individuals and healthcare facilities that received these products should contact Medline Industries for instructions regarding replacement or proper handling of these kits.
The recalled product
- Product
- Medline Convenience kits used for various procedures: 1) CW PERI GYN, Model Number: DYNJ80807B
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Hazard
- packaging-defect
- 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) DYNJ80807B
- UDI-DI: 10195327415624(each)
- 40195327415625(case)
- Lot Number: 24IBH993
Distribution
Distributed nationwide across the United States.
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