The Recall Desk
HighFDA (Devices)·Z-2334-2023·Announced 2023-08-09

Medline sterile procedural kits recalled for potential sterility specification failures

Medline is recalling custom sterile and non-sterile procedural kits containing Turkuaz Ultrasound Gel due to potential sterility specification failures. The kits were distributed worldwide to hospitals and medical facilities.

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 recall is classified as High because it involves a risk-of-harm product—sterile procedural kits that may not meet sterility specifications—where no illnesses or injuries have been reported to date. Per the rubric, a theoretical hazard with no reported illness in a Class II device recall qualifies as High.

Plain-English summary

Medline Industries is recalling three models of custom sterile and non-sterile procedural kits containing Turkuaz Ultrasound Gel: CV MINOR PACK (Model DYNJ64862A, UPC 019348942033), DBD-C SECTION ADM (Model DYKL1816, UPC 019532705432), and FETAL SURGERY (Model DYNJ908118A, UPC 019532730349). A total of 371 kits are affected. The sterile ultrasound gel component within these kits has the potential to not meet sterility specifications. All lots of the affected models distributed between April 1, 2020 and April 28, 2023 are included in this recall.

The kits were 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. Healthcare facilities that received these products should cease use immediately.

Healthcare providers should contact Medline Industries for guidance on product returns or replacements. The FDA is monitoring this recall to ensure proper resolution.

The recalled product

Product
Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. C V MINOR PACK, Model Number: DYNJ64862A; b. DBD-C SECTION ADM, Model Number: DYKL1816; c. FETAL SURGERY, Model Number: DYNJ908118A;
Manufacturer
MEDLINE INDUSTRIES, LP - Northfield
Category
Medical Device — Procedural Kits / Ultrasound Gel
Hazard
  • sterility-failure

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 (3)

  • UPC Number: 019348942033. b. Model Number: DYKL1816
  • UPC Number: 019532705432. c. Model Number: DYNJ908118A
  • UPC Number: 019532730349.

Distribution

Distributed nationwide across the United States.

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