Procedural kits containing Turkuaz ultrasound gel recalled for sterility failure
Medline Industries recalls approximately 97,677 procedural kits containing Turkuaz Ultrasound Gel due to potential sterility specification failures. The affected kits were distributed worldwide from April 1, 2020 to April 28, 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 medical device recall where the ultrasound gel component may not meet sterility specifications. Since no illnesses or injuries are reported and the hazard remains theoretical, the recall qualifies as a high-severity risk-of-harm product without documented injury.
Plain-English summary
Medline Industries is recalling approximately 97,677 procedural kits that contain Turkuaz Ultrasound Gel. The kits include multiple models used for medical procedures such as central venous catheter insertion, angiography, ablation, and other interventional procedures.
The labeled sterile ultrasound gel component within these kits has the potential to not meet sterility specifications. Non-sterile gel used in sterile procedures creates a contamination risk.
The affected kits were distributed worldwide to the United States, Canada, China, Costa Rica, India, Lebanon, Panama, Qatar, Saudi Arabia, Singapore, and the United Arab Emirates. All lot numbers of the specified models distributed from Medline between April 1, 2020 and April 28, 2023 are included.
Healthcare providers with affected kits should verify their inventory using the listed model numbers and UPC codes. Contact Medline Industries regarding the recall.
The recalled product
- Product
- Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. (13) STC IVC FILTER/ANGIOGRAM, Model Number: DYNJ908249A; b. 16CM 3L 7FR CVC INSERTION BUNDLE, Model Numbers: ECVC7410A; c. 16CM 7F 3L CVC MAX BARRIER…
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Affected units
- 97,677
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 (20)
- UPC Number: 019532724050. b. Model Number: ECVC7410A
- UPC Number: 10653160353645. c. Model Number: ECVC2205A
- UPC Number: 10653160357148. d. Model Number: ECVC8095
- UPC Number: 10653160357759. e. Model Number: ECVC5010A
- UPC Number: 10653160335290. f. Model Number: ECVC6800A
- UPC Number: 10653160355694. g. Model Number: ECVC2555
- UPC Number: 10653160336570. h. Model Number: ECVC4125
- UPC Number: 10653160339502. i. Model Number: ECVC5135B
- UPC Number: 10653160353652. j. Model Number: ECVC7325
- UPC Number: 10653160345589. k. Model Number: ECVC1970B
- UPC Number: 10653160357155. l. Model Number: ECVC4335
- UPC Number: 10653160357285. m. Model Number: ECVC7160
- UPC Number: 10653160335306. n. Model Number: ECVC2560
- UPC Number: 10653160334286. o. Model Number: ECVC3505
- UPC Number: 10653160334767. p. Model Number: ECVC7075
- UPC Number: 10653160335122. q. Model Number: ECVC8055
- UPC Number: 10653160355656. r. Model Number: ECVC8165
- UPC Number: 10653160358749. s. Model Number: ECVC4635A
- UPC Number: 10653160352112
- Model Number: ECVC7040A
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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