Medline Rhinoplasty Convenience Kit Recalled Due to Potential Seal Failures
Medline is recalling Rhinoplasty Convenience Kits (Model DYNJ84116A, Lot 24IBH580) due to potential open or weak seals on breather pouches. Compromised seals could affect package sterility, though no illnesses have been reported.
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 sterile medical device where the hazard is potential package seal failure that could compromise sterility. No illnesses or injuries have been reported, and the hazard is theoretical rather than confirmed. This qualifies as High (3) per the rubric as a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Medline Industries is recalling Rhinoplasty Convenience Kits, Model Number DYNJ84116A, Lot Number 24IBH580, due to a potential for open or weak seals on the breather pouches used for packaging these sterile kits. These pouches are essential for maintaining the sterility of the surgical instruments and supplies contained within the kit.
The affected kits have been distributed worldwide, including throughout the United States, Canada, Mexico, Panama, and the U.S. Virgin Islands. Approximately 60 units were distributed under this lot number. The FDA has classified this as a Class II recall. While no illnesses or injuries have been reported to date, compromised package seals could potentially allow contamination of the sterile contents.
If you have received these kits, you should stop using them and verify the package seal integrity before use. Contact Medline Industries for instructions on product replacement or return. For product identification, reference UDI-DI number 10198459062438 (individual package) or 40198459062439 (case level).
The recalled product
- Product
- Medline Convenience kits used for various procedures: 1) RHINOPLASTY PACK, Model Number: DYNJ84116A
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Category
- Medical Device — Surgical Kit
- Hazard
- compromised-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) DYNJ84116A
- UDI-DI: 10198459062438(each)
- 40198459062439(case)
- Lot Number: 24IBH580
Distribution
Distributed nationwide across the United States.
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