Medline Convenience Kits Rhinoplasty Pack Potential Weak Seals Recall
Medline Industries is recalling Rhinoplasty Pack convenience kits (Model DYNJ84116A, Lot 24IBH580) due to potential open or weak seals on breather pouches used for packaging. Compromised packaging may affect sterility of the sterile kits.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is an FDA Class II recall involving a medical device with a packaging-integrity issue. No illnesses or injuries have been reported; the hazard is potential compromise of sterility. Class II recalls without reported harm are typically scored as 2 (Moderate) per the rubric.
Plain-English summary
Medline Industries, LP is recalling select Rhinoplasty Pack convenience kits, Model Number DYNJ84116A (Lot Number 24IBH580, UDI-DI: 10198459062438), distributed worldwide including the US, Canada, Mexico, Panama, and the Virgin Islands. The recall affects 60 units.
The recalled kits contain breather pouches with a potential for open or weak seals. Compromised packaging seals may allow the sterile convenience kits to lose their sterile status.
Consumers or healthcare facilities that have purchased affected units should stop use and contact Medline Industries for instructions on return or replacement. The FDA classification for this recall is Class II.
The recalled product
- Product
- Medline Convenience kits used for various procedures: 1) RHINOPLASTY PACK, Model Number: DYNJ84116A
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Hazard
- packaging-seal-failure
- 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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