The Recall Desk
HighFDA (Devices)·Z-2313-2023·Announced 2023-08-09

Sterile Procedural Kits Recalled Due to Potential Ultrasound Gel Sterility Failure

Medline Industries is recalling Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel because the gel component may not meet sterility specifications. The kits are distributed worldwide for dialysis procedures.

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: The FDA has classified this as a Class II medical device recall involving potential sterility failure in a component used for invasive dialysis procedures. No injuries, illnesses, or adverse events are documented in the recall notice. Per the severity rubric, a risk-of-harm medical device without reported injury is scored as High.

Plain-English summary

Medline Industries, LP is recalling Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. The recalled kits are labeled as DIALYSIS ACCESSORY PACK W/O CATHETER (Model MNS10750A, UPC 10653160356073) and STD INSERTION/DIALYSIS INSERTION TRAY (Model CVI3845, UPC 10653160270072).

The recall is due to a potential for the labeled sterile ultrasound gel component within the kits to not meet sterility specifications. Ultrasound gel that does not meet sterility standards poses a risk of contamination when used in invasive dialysis procedures.

135 kits have been distributed worldwide, including throughout the United States and to 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 the recall.

Healthcare facilities and providers using these kits should discontinue use and contact Medline Industries for return authorization or replacement products. Those with questions about the recall should contact the FDA.

The recalled product

Product
Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. DIALYSIS ACCESSORY PACK W/O CATHETER, Model Number: MNS10750A; b. STD INSERTION/DIALYSIS INSERTION TRAY, Model Number: CVI3845;
Manufacturer
MEDLINE INDUSTRIES, LP - Northfield
Category
Medical Device — Dialysis / Surgical Kits
Hazard
  • sterility-failure
  • contamination-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 (2)

  • UPC Number: 10653160356073. b. Model Number: CVI3845
  • UPC Number: 10653160270072.

Distribution

Distributed nationwide across the United States.

Related recalls

Same category