Medline Procedural Kits Recalled for Potential Sterility Failure in Ultrasound Gel
Medline Industries is recalling 7,040 custom sterile procedural kits containing ultrasound gel because the gel component may not meet sterility specifications, creating a potential infection risk.
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: FDA Class II recall involving a sterile medical device component with potential sterility failure. Although no illnesses or injuries are reported, sterility failures in medical devices used in clinical procedures pose a risk of serious infection, qualifying this as a risk-of-harm scenario without yet-reported injury.
Plain-English summary
Medline Industries, LP, is recalling 7,040 custom sterile and non-sterile procedural kits containing Turkuaz Ultrasound Gel. The affected kits include KIT TRIAGE ADMIT (Model DYKA1456), KIT ANTE PARTUM (Model DYKL1844), and MATERNAL ADMIT KIT (Model DYKM2091).
The ultrasound gel component within these kits may not meet required sterility specifications. Non-sterile gel could pose a risk of infection if used in clinical procedures.
The recalled kits were distributed worldwide, including throughout the United States and to Canada, China, Costa Rica, India, Lebanon, Panama, Qatar, Saudi Arabia, Singapore, and the United Arab Emirates. All lot numbers of the three affected models distributed between April 1, 2020, and April 28, 2023, are included in this recall.
Healthcare facilities and other recipients of these kits should discontinue use and contact Medline Industries for instructions on obtaining replacement kits.
The recalled product
- Product
- Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. KIT TRIAGE ADMIT, Model Number: DYKA1456; b. KIT,ANTE PARTUM, Model Number: DYKL1844; c. MATERNAL ADMIT KIT, Model Number: DYKM2091
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Category
- Medical Device — Procedural Kits
- Affected units
- 7,040
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)
- UPC Number: 019532723188. b. Model Number: DYKL1844
- UPC Number: 019532723181. c. Model Number: DYKM2091
- UPC Number: 019348998356.
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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