Medical procedural kits recalled due to sterility concerns with ultrasound gel
Medline recalls 76,870 procedural kits because the ultrasound gel component may not meet sterility standards. Kits were distributed nationwide and internationally from April 2020 through 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 recall involves sterile medical device components where the potential for sterility failure poses a risk of serious infection in invasive medical procedures. Although no illnesses or injuries are reported in the source text, this is a risk-of-harm product where injury has not yet been reported, which per the rubric corresponds to High (3) severity.
Plain-English summary
Medline Industries is recalling 76,870 sterile and non-sterile procedural kits that contain Turkuaz Ultrasound Gel. The kits were distributed from April 2020 through April 2023 to facilities in the United States and multiple countries including Canada, China, Costa Rica, India, Lebanon, Panama, Qatar, Saudi Arabia, Singapore, and the United Arab Emirates.
The recall was initiated because the labeled sterile ultrasound gel component within the kits has the potential to not meet sterility specifications. This could compromise the safety of medical procedures if the gel does not maintain proper sterility.
The affected kits include numerous models used for central venous catheter insertion, dialysis procedures, interventional radiology procedures, and other medical interventions. Model numbers and UPC codes for all affected products are available on the FDA website.
Healthcare facilities should stop using affected kits immediately and verify whether any recalled units are in their inventory by checking product model numbers and UPC codes. Unused recalled kits should be removed from service and the manufacturer should be contacted for instructions regarding return or replacement.
The recalled product
- Product
- Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. CRMC MINOR IR PROCEDURE PK-LF, Model Numbers: DYNJ61099B, DYNJ61099C; b. CRMC TUNNEL CATH TRAY-LF, Model Numbers: DYNJ61118C, DYNJ61118F; c. CUSTOM ANGIO TRAY…
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Affected units
- 76,870
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: 019532711185
- Model Number: DYNJ61099C
- UPC Number: 019532726200. b. Model Number: DYNJ61118C
- UPC Number: 019348946397
- Model Number: DYNJ61118F
- UPC Number: 019532726198. c. Model Number: DYNJ41649G
- UPC Number: 019532727729. d. Model Number: ECVC2595
- UPC Number: 10653160332596. e. Model Number: CDS984100U
- UPC Number: 019532714613
- Model Number: CDS984100V
- UPC Number: 019532725205. f. Model Number: ECVC2225
- UPC Number: 10653160334385. g. Model Number: ECVC7265A
- UPC Number: 10653160345145. h. Model Number: ECVC3235
- UPC Number: 10653160336112. i. Model Number: ECVC2335
- UPC Number: 10653160332497. j. Model Number: ECVC5120B
- UPC Number: 10653160333180. k. Model Number: ECVC5095B
- UPC Number: 10653160333173. l. Model Number: ECVC6075
- UPC Number: 10653160338437
- Model Number: ECVC6460
- UPC Number: 10653160335085. m. Model Number: ECVC2240A
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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