The Recall Desk
HighFDA (Devices)·Z-2307-2023·Announced 2023-08-09

Medline Procedural Kits with Turkuaz Ultrasound Gel Recalled for Sterility Concerns

Medline is recalling custom sterile procedural kits containing Turkuaz ultrasound gel due to potential sterility specification failures. The kits were distributed worldwide 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 of sterile medical devices used in invasive procedures where a sterility specification failure could introduce infection. Although no illnesses have been reported, the recall meets the rubric criterion for 'risk-of-harm products where injury has not yet been reported,' warranting a High severity score.

Plain-English summary

Medline Industries is recalling custom sterile and non-sterile procedural kits that contain Turkuaz ultrasound gel. The recall affects 26 different kit models used for biopsies, ablation, drainage, and other medical procedures, with a total of 43,613 kits affected.

The kits are being recalled because the sterile ultrasound gel component may not meet sterility specifications. If the gel is not properly sterilized, it could introduce bacteria or other microorganisms into the body during medical procedures.

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

Facilities using these kits should stop use immediately and contact Medline Industries for instructions on returns or disposal. Healthcare providers should review their inventory to identify affected units using the model numbers and UPC codes provided in the FDA recall notice.

The recalled product

Product
Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. ABLATION/DRAINAGE PACK, Model Number: DYNJ53658B; b. BASIC BIOPSY TRAY, Model Number: DYNDH1534; c. BIOPSY PACK, Model Number: DYNDH1124, DYNJ50485;
Manufacturer
MEDLINE INDUSTRIES, LP - Northfield
Category
Medical Device — 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: 019532708870. b. Model Number: DYNDH1534
  • UPC Number: 019348919708. c. Model Number: DYNDH1124
  • UPC Number: 088994230327
  • Model Number: DYNJ50485
  • UPC Number: 088827799279
  • Model Number: DYNDH1124
  • UPC Number: 10889942303274. d. Model Number: DYNJ0747885G
  • UPC Number: 019532708872. e. Model Number: DYNJ59752A
  • UPC Number: 019348959857. f. Model Number: DYNDH1748
  • UPC Number: 019532716474
  • Model Number: DYNJ34637F
  • UPC Number: 019348956435
  • Model Number: DYNJ34637G
  • UPC Number: 019348936880
  • Model Number: DYNJ43076
  • UPC Number: 088827702453
  • Model Number: DYNJ43076A
  • UPC Number: 019532708062
  • Model Number: DYNJ62690
  • UPC Number: 019348968226. g. Model Number: DYNJ42307A

Distribution

Distributed nationwide across the United States.

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