The Recall Desk
HighFDA (Devices)·Z-2323-2023·Announced 2023-08-09

Medline Procedural Kits with Turkuaz Ultrasound Gel May Not Meet Sterility Requirements

Medline is recalling 218,163 sterile procedural kits containing Turkuaz Ultrasound Gel that may not meet sterility specifications. Kits distributed April 2020-April 2023 are used in invasive medical 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: This is an FDA Class II recall for medical device procedural kits with potential sterility specification failures. No illnesses or injuries are mentioned in the recall announcement. Per the rubric, this represents a risk-of-harm product without reported injury, warranting a score of 3 (High).

Plain-English summary

Medline Industries, LP is recalling 218,163 sterile and non-sterile procedural kits that contain Turkuaz Ultrasound Gel. The affected kits include 43 different model numbers used for medical procedures such as peripheral intravenous catheter insertion, PICC line insertion, arterial line insertion, and midline catheter insertion.

The recall was initiated due to potential sterility specification failures of the ultrasound gel component in these kits. Ultrasound gel that does not meet sterility requirements could pose risks in invasive medical procedures.

The affected 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. All lot numbers of the affected model numbers distributed between April 1, 2020, and April 28, 2023, are included in this recall.

Healthcare facilities and distributors should immediately stop using affected kits and verify their inventory using the provided model numbers and UPC codes. Contact Medline Industries or the FDA for proper handling and disposition of recalled products.

The recalled product

Product
Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. ADULT EPIV INSERTION TRAY, Model Number: DYNDA2482; b. ARTERIAL LINE START KIT, Model Number: ART920; c. CENTRAL LINE INSERTION TRAY, Model Number: DT19810;
Manufacturer
MEDLINE INDUSTRIES, LP - Northfield
Category
Medical Device — Surgical Kits / Procedure Trays
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: 10193489198188. b. Model Number: ART920
  • UPC Number: 10653160327899. c. Model Number: DT19810
  • UPC Number: 10653160285656. d. Model Number: CVI4915
  • UPC Number: 10653160355489. e. Model Number: IVS3770
  • UPC Number: 10653160328230. f. Model Number: DYNDV2407A
  • UPC Number: 019348981701. g. Model Number: MID0005
  • UPC Number: 10653160349181. h. Model Number: CVI4340
  • UPC Number: 10653160309475. i. Model Number: MIDST04011
  • UPC Number: 10653160350699. j. Model Number: MID0001
  • UPC Number: 10193489381627. k. Model Number: DYNJ80141MB
  • UPC Number: 10889942733415
  • Model Number: MID0003
  • UPC Number: 10653160349334. l. Model Number: PICC0009A
  • UPC Number: 10193489760231. m. Model Number: DYNJ80152MB
  • UPC Number: 10889942733422. n. Model Number: DYNDA2509A
  • UPC Number: 10193489196986
  • Model Number: MNS8765
  • UPC Number: 10653160270515. o. Model Number: DYNDC2120B
  • UPC Number: 10193489198270. p. Model Number: CVI3740A
  • UPC Number: 10653160324416. q. Model Number: IVS3990

Distribution

Distributed nationwide across the United States.

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