The Recall Desk
HighFDA (Devices)·Z-2310-2023·Announced 2023-08-09

Custom Procedural Kits with Ultrasound Gel May Not Meet Sterility Standards

Medline recalls 4,618 custom sterile procedural kits distributed worldwide from April 2020 through April 2023. The Turkuaz ultrasound gel component may not meet sterility specifications, posing a potential infection risk in surgical 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: FDA Class II recall of a sterility specification failure in medical device components used in invasive surgical procedures. No illnesses or injuries have been reported. This constitutes a risk-of-harm product where injury has not yet been reported, fitting the High (3) category.

Plain-English summary

Medline Industries, LP is recalling custom sterile and non-sterile procedural kits containing Turkuaz ultrasound gel. The recalled kits include DBD-PACK FETOSCOPY (model DYNJ906905B), FETOSCOPY CDS-LF (model CDS840215O), PACK FETOSCOPY (model DYNJ906905A), and US BREAST BIOPSY TRAY (model DYNDH1187A). A total of 4,618 kits were distributed.

The ultrasound gel component labeled as sterile in some of these kits may not meet required sterility specifications. When non-sterile gel is used in sterile surgical procedures such as fetoscopy and breast biopsy, it poses a potential risk of infection to patients.

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

Consumers and healthcare facilities should immediately cease use of affected kits and contact Medline Industries for instructions on how to handle the recalled products.

The recalled product

Product
Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. DBD-PACK FETOSCOPY, Model Number: DYNJ906905B; b. FETOSCOPY CDS-LF, Model Number: CDS840215O; c. PACK,FETOSCOPY, Model Number: DYNJ906905A; d. US BR
Manufacturer
MEDLINE INDUSTRIES, LP - Northfield
Category
Medical Device — Surgical and Procedural Kits
Hazard
  • sterility-failure
  • contamination-risk
  • 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 (4)

  • UPC Number: 019348988494. b. Model Number: CDS840215O
  • UPC Number: 019348944899. c. Model Number: DYNJ906905A
  • UPC Number: 019348939112. d. Model Number: DYNDH1187A
  • UPC Number: 088994270263.

Distribution

Distributed nationwide across the United States.

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