Medline Myringotomy Kits Recalled for Potential Sterility Compromise
Medline Industries is recalling 60 Myringotomy Pack-LF kits due to open seals that may compromise sterility and lead to patient infection.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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: The recall involves a risk-of-harm product (sterility compromise leading to potential infection) where injury has not yet been reported, fitting the High severity criteria.
Plain-English summary
Medline Industries, LP is recalling 60 units of Myringotomy Pack-LF convenience kits (Catalog No. DYNJ59097A, Lot 25FBU754). The recall is due to reports that the sterile pouch packaging may exhibit open seals. This defect may compromise the sterility of the product.
The affected kits were distributed nationwide in Arkansas, Florida, North Carolina, Maryland, and Texas. If the open seal is not detected prior to use, the issue may lead to contamination of the sterile field or patient infection.
Healthcare facilities should check their inventory for this specific lot number and stop using any affected kits. Users should contact Medline Industries for further instructions or to arrange for return of the product.
The recalled product
- Product
- Convenience kits MYRINGOTOMY PACK-LF DYNJ59097A
- Manufacturer
- Medline Industries, LP
- Category
- Medical Device — Surgical Kits
- Affected units
- 60
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 (1)
- UDI-DI 10198459046551 Lot 25FBU754
Distribution
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