The Recall Desk
HighFDA (Devices)·Z-2322-2023·Announced 2023-08-09

Custom procedural kits recalled for potential sterility failure in ultrasound gel

Medline recalled 134,514 custom surgical procedural kits due to potential sterility failure in the Turkuaz Ultrasound Gel component. The affected kits were distributed worldwide from April 1, 2020 through April 28, 2023.

What this means for you

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 where potential sterility failure of ultrasound gel in surgical kits represents a risk-of-harm scenario. Although no injuries are reported in the source, non-sterile materials in invasive medical procedures pose a documented risk of infection, qualifying this as High severity per the rubric criteria for risk-of-harm products.

Plain-English summary

Medline Industries has recalled 134,514 custom sterile and non-sterile procedural kits containing Turkuaz Ultrasound Gel due to potential failure of the gel component to meet sterility specifications. The affected kits include numerous specialized surgical and procedural trays and bundles, such as arterial line kits, central line insertion kits, biopsy trays, amniocentesis trays, nerve block trays, and many others. The products were distributed worldwide between April 1, 2020 and April 28, 2023.

The recall was issued because the labeled sterile ultrasound gel component within the kits has the potential to not meet sterility specifications. When sterility specifications are not met in medical devices used in invasive surgical procedures, there is a risk of infection and other complications.

The affected kits were distributed to the United States nationwide and internationally to Canada, China, Costa Rica, India, Lebanon, Panama, Qatar, Saudi Arabia, Singapore, and the United Arab Emirates. Healthcare facilities and medical professionals should verify their inventory against the detailed model numbers and UPC codes provided by the FDA to identify affected products.

The recalled product

Product
Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. 18GX6" FEMORAL ART LINE KIT, Model Number: ART960; b. 20Gx3" RADIAL ART LINE KIT, Model Number: ART970; c. 20GX6" FEMORAL ART LINE KIT, Model Number: ART1165;
Manufacturer
MEDLINE INDUSTRIES, LP - Northfield
Category
Medical Device — Surgical/Procedural Kits
Hazard
  • sterility-failure
  • infection-risk

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: 10193489190915. b. Model Number: ART970
  • UPC Number: 10193489190922. c. Model Number: ART1165
  • UPC Number: 10653160354680. d. Model Number: ART240A
  • UPC Number: 10653160328025. e. Model Number: ART245A
  • UPC Number: 10653160328018
  • Model Number: ART245B
  • UPC Number: 10653160358442. f. Model Number: ART690
  • UPC Number: 10653160318019. g. Model Number: ART645
  • UPC Number: 10653160314394. h. Model Number: MNS8750
  • UPC Number: 065316027073. i. Model Number: DT22570A
  • UPC Number: 10653160346074. j. Model Number: ART865
  • UPC Number: 10653160325062. k. Model Number: ART255
  • UPC Number: 10653160311997
  • Model Number: ART560
  • UPC Number: 10653160310822. l. Model Number: ART840
  • UPC Number: 10653160322924. m. Model Number: SPEC0232
  • UPC Number: 10888277507418. n. Model Number: DYNDH1534
  • UPC Number: 10193489197082. o. Model Number: MNS12065
  • UPC Number: 10653160331193. p. Model Number: MNS7695A
  • UPC Number: 10653160343455. q. Model Number: DYNDH1661

Distribution

Distributed nationwide across the United States.

Related recalls

Same category