Medline Anesthesia Procedural Kits Recalled for Potential Sterility Failure
Medline Industries recalls 1,130 anesthesia procedural kits over concerns that the sterile ultrasound gel component may not meet sterility specifications. The kits were distributed worldwide including the US from April 2020 to April 2023.
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 device recall involving sterile procedural kits with potential sterility failure. While no hospitalizations or injuries have been reported, sterile components failing to meet sterility specifications in medical devices pose a significant risk of harm to patients. The hazard is theoretical but substantial, fitting the rubric criterion for Score 3: High (risk-of-harm products where injury has not yet been reported).
Plain-English summary
Medline Industries has recalled 1,130 custom sterile and non-sterile procedural kits that contain Turkuaz ultrasound gel. The affected kits are identified by two model numbers: DYNJ52283C (ANESTHESIA CVL KIT-LF) and DYNJ61476 (ANESTHESIA OH TOTE). The recall was issued because the labeled sterile ultrasound gel component within the kits may not meet sterility specifications.
All kits bearing these model numbers with lot numbers distributed between April 1, 2020, and April 28, 2023, are affected by this recall.
The affected kits were distributed worldwide, including throughout the United States and internationally to Canada, China, Costa Rica, India, Lebanon, Panama, Qatar, Saudi Arabia, Singapore, and the United Arab Emirates.
The recalled product
- Product
- Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. ANESTHESIA CVL KIT-LF, Model Number: DYNJ52283C; b. ANESTHESIA OH TOTE, Model Number: DYNJ61476;
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Hazard
- Affected units
- 1,130
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 (2)
- UPC Number: 019348965000. b. Model Number: DYNJ61476
- UPC Number: 019348957199.
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 50 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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