Anesthesia Turnover Kit with Non-Sterile Mastisol Component Recalled
Medline Industries recalls Anesthesia Turnover Kit Pack Number DYNJAA0377 due to a non-sterile Mastisol component placed in the sterile kit without proper labeling. This poses an infection risk if users assume the component is sterile.
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 FDA Class II recall involves a medical device with a high-risk infection hazard—a non-sterile component in a sterile kit without proper labeling. Although no illnesses or injuries have been reported, the risk-of-harm nature of the product classifies this as High severity per FDA recall criteria.
Plain-English summary
Medline Industries, LP has recalled the Anesthesia Turnover Kit, Pack Number DYNJAA0377. A non-sterile Mastisol component was included in the kit without being labeled as non-sterile. The affected product was distributed to facilities in Texas, Illinois, and California.
The concern is that if a user assumes the Mastisol component is sterile during use, there is an increased risk of patient infection. The component was placed in the non-sterile portion of the kit but lacked clear labeling indicating its non-sterile status.
A total of 105 units were affected by this recall. The affected lot number is 22LBM357 (UDI/DI Case 40195327231126; UDI/DI Each 10195327231125).
The recalled product
- Product
- ANESTHESIA TURNOVER KIT, Pack Number DYNJAA0377
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Category
- Medical Device — Anesthesia Kit
- Hazard
- mis-labeling
- infection-risk
- sterility-breach
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 (3)
- UDI/DI Case 40195327231126
- UDI/DI Each 10195327231125
- Lot Numbers: 22LBM357
Distribution
Distributed in 3 states:
- CA
- IL
- TX
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