The Recall Desk
HighFDA (Devices)·Z-2338-2023·Announced 2023-08-09

Medline procedural kits recalled for ultrasound gel sterility concerns

Medline is recalling 15,323 custom sterile and non-sterile procedural kits worldwide due to potential non-sterility of the Turkuaz ultrasound gel component. Kits were distributed between April 2020 and April 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: This is an FDA Class II recall with no reported illnesses or injuries. The hazard involves potential non-sterility of gel used in sterile invasive procedures, creating a risk of infection. Per the rubric, a risk-of-harm product without reported injury scores as High (3).

Plain-English summary

Medline Industries, LP is recalling 15,323 custom sterile and non-sterile procedural kits containing Turkuaz ultrasound gel. The recalled kits include 28 different models used for various surgical and procedural applications, including angiography, arthrograms, nerve blocks, craniotomy, and hip and knee replacement procedures.

The recall was issued because the sterile ultrasound gel component within some kits may not meet sterility specifications. If ultrasound gel used in sterile procedures is not actually sterile, it poses a risk of introducing bacterial or fungal contamination during invasive procedures.

The affected kits were distributed worldwide, including throughout the United States, Canada, China, Costa Rica, India, Lebanon, Panama, Qatar, Saudi Arabia, Singapore, and the United Arab Emirates. All lot numbers of the affected models distributed between April 1, 2020, and April 28, 2023, are included in this recall.

Healthcare facilities and healthcare professionals using these kits should stop using them and contact Medline Industries for instructions on replacement or refund. No illnesses or injuries have been reported as of the recall announcement.

The recalled product

Product
Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. ANGIOGRAPHY PACK, Model Number: DYNJ65963A; b. ARTHOGRAM TRAY, Model Number: PAIN1524B; c. ARTHROGRAM TRAY, Model Number: PAIN1524A; d. CARPAL TUNNEL K
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: 019348999205. b. Model Number: PAIN1524B
  • UPC Number: 019348999446. c. Model Number: PAIN1524A
  • UPC Number: 019348932800. d. Model Number: DYNJ63149A
  • UPC Number: 019348978647. e. Model Number: CDS981753L
  • UPC Number: 019532723862. f. Model Number: CDS982889I
  • UPC Number: 088994220806. g. Model Number: DYNJ61749A
  • UPC Number: 019532706301. h. Model Number: DYNDH1722
  • UPC Number: 019532713216. i. Model Number: OST011E
  • UPC Number: 088827758932. j. Model Number: DYNJ909168
  • UPC Number: 019532728659. k. Model Number: DYNJ909169
  • UPC Number: 019532728660. l. Model Number: DYNJ56907D
  • UPC Number: 019348983156. m. Model Number: DYNJ50712C
  • UPC Number: 019348987016. n. Model Number: SPEC0204D
  • UPC Number: 019348930298. o. Model Number: DYNJ69312
  • UPC Number: 019348992946
  • Model Number: DYNJ69312A
  • UPC Number: 019532721677. p. Model Number: DYNJ53035B
  • UPC Number: 088827776381. q. Model Number: DYNJRA1619
  • UPC Number: 019348931184. r. Model Number: PHS392881009C
  • UPC Number: 019348922233. s. Model Number: DYNJ906551A

Distribution

Distributed nationwide across the United States.

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