Sterile Anesthesia Kits Recalled for Non-Sterile Component Mixing
Medline Industries recalled anesthesia kits containing an unlabeled non-sterile Mastisol component that could be mistakenly assumed sterile during use, creating infection risk. The recall affects 315 units distributed in Texas, Illinois, and California.
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: This is an FDA Class II recall with no reported illnesses or injuries. The hazard is theoretical but significant: an unlabeled non-sterile component in sterile surgical kits could cause patient infection if users assume sterility. This meets the rubric criterion for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Medline Industries has recalled the ANESTHESIA TURNOVER KIT (Pack Number DYNJAA0377A), affecting 315 units with lot numbers 23IBJ309, 23GBA500, 23GBA457, 23CBE394, and 23BBL312.
The kits contain a Mastisol component that is non-sterile but was not labeled to indicate this. The unlabeled component was included in the kits, which are otherwise sterile. If users assume the component is sterile during use, there is an increased risk of patient infection.
The affected kits were distributed in Texas, Illinois, and California. Healthcare facilities and users of these kits should discontinue use and contact Medline Industries for information about returns or replacements.
The recalled product
- Product
- ANESTHESIA TURNOVER KIT, Pack Number DYNJAA0377A
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Affected units
- 315
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 (7)
- UDI/DI Case 40195327334209
- UDI/DI Each 10195327334208
- Lot Numbers: 23IBJ309
- 23GBA500
- 23GBA457
- 23CBE394
- 23BBL312
Distribution
Part of a larger recall action
This product is one of 4 recalled by MEDLINE INDUSTRIES, LP - Northfield under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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