Medline Anesthesia Pain Kits Recalled for Potential Sterility Compromise
Medline Industries is recalling 341 anesthesia pain kits due to open sterile 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 341 units of Convenience Kits ANESTHESIA PAIN PK LEAGUE (DYNJ67925A) because 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. The specific lot number is 25BBK494, and the UDI-DI is 10195327506506.
If the open seal is not detected prior to use, the issue may lead to contamination of the sterile field or patient infection. Healthcare providers should inspect the packaging for integrity before use and contact Medline Industries for further instructions.
The recalled product
- Product
- Convenience kits ANESTHESIA PAIN PK LEAGUE DYNJ67925A
- Manufacturer
- Medline Industries, LP
- Category
- Medical Device — Anesthesia Kits
- Affected units
- 341
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 10195327506506 Lot 25BBK494
Distribution
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