Medline Rhinoplasty Kits Recalled for Weak Packaging Seals
Medline is recalling 56 Rhinoplasty Packs due to weak or open seals on breather pouches. The packaging defect may compromise sterility of the surgical 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 of a sterile surgical product with a packaging defect that could compromise sterility. While no illnesses or injuries have been reported, the defect poses a potential risk of harm to patients if the compromised kits are used in procedures.
Plain-English summary
Medline Industries is recalling 56 units of its Rhinoplasty Pack (Model DYNJ27333F) due to a packaging defect. The issue involves weak or open seals on breather pouches used to package these sterile surgical convenience kits.
When breather pouches have weak or open seals, the sterility of the surgical kit may be compromised. This could allow contamination of the sterile medical device, potentially affecting patient safety if used in procedures.
The affected lot (24KBH228) was distributed worldwide, including to customers in the United States, Canada, Mexico, Panama, and the Virgin Islands. The recall affects a limited quantity of 56 units.
Healthcare facilities and individuals who have received Rhinoplasty Packs from this lot should stop using them and contact Medline Industries or refer to the FDA recall notice for instructions on replacement or return.
The recalled product
- Product
- Medline Convenience kits used for various procedures: 1) RHINOPLASTY PACK, Model Number: DYNJ27333F
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Hazard
- weak-seal
- open-seal
- 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) DYNJ27333F
- UDI-DI: 10888277055292(each)
- 40888277055293(case)
- Lot Number: 24KBH228
Distribution
Distributed nationwide across the United States.
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