The Recall Desk
HighFDA (Devices)·Z-2331-2023·Announced 2023-08-09

Medline Procedural Kits Recalled Due to Sterility Specification Failure

Medline Industries recalls 15,945 Custom Sterile and Non-Sterile Procedural Kits due to potential failure of the Turkuaz ultrasound gel component to meet sterility specifications. 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 a sterile medical device component used in surgical and procedural kits. Although no illnesses or injuries have been reported, the potential failure to meet sterility specifications poses a risk of infection in surgical contexts, qualifying as a risk-of-harm product without documented adverse events.

Plain-English summary

Medline Industries, LP is recalling Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz ultrasound gel. The recall includes 15,945 kits with multiple model numbers used in various surgical and procedural settings. Affected models include ANGIO, ANGIOGRAPHIC PACK, CATH ANGIO PACK, NEURO PACK, and numerous other surgical kit configurations.

The ultrasound gel component labeled as sterile within these kits may not meet sterility specifications. This potential sterility specification failure poses a risk to patient safety in surgical and procedural applications where these kits are used.

The affected 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.

Healthcare facilities and providers who have these kits in stock should verify the affected lot numbers against the model numbers and UPC codes provided by the manufacturer, cease use of affected lots, and contact Medline Industries for replacement or return instructions.

The recalled product

Product
Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. ANGIO, Model Number: DYNJ905151A; b. ANGIO/VENO PACK, Model Number: DYNJ58346A; c. ANGIOGRAPHIC PACK, Model Number: DYNJ57442C, DYNJ64081A; d. ANGIOGRA
Manufacturer
MEDLINE INDUSTRIES, LP - Northfield
Category
Medical Device — Surgical/Procedural Kits
Hazard
  • sterility-failure
  • contamination

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: 019348981341. b. Model Number: DYNJ58346A
  • UPC Number: 019348977463. c. Model Number: DYNJ57442C
  • UPC Number: 019348920853
  • Model Number: DYNJ64081A
  • UPC Number: 019348927374. d. Model Number: DYNJ65963
  • UPC Number: 019348930770. e. Model Number: DYNJ64655
  • UPC Number: 019348921040. f. Model Number: SPEC0232
  • UPC Number: 088827750741. g. Model Number: DYNJ62591A
  • UPC Number: 019348979331. h. Model Number: DYNJ39752A
  • UPC Number: 088438990723. i. Model Number: DYNJ53064B
  • UPC Number: 019348978916. j. Model Number: DYNJ64050
  • UPC Number: 019348978046. k. Model Number: DYKMBNDL148
  • UPC Number: 019348947839. l. Model Number: DYNJ0878178I
  • UPC Number: 019348956435. m. Model Number: DYNJ57760A
  • UPC Number: 019348922023. n. Model Number: DYNJ57032C
  • UPC Number: 019348945147. o. Model Number: DYNJ39198L
  • UPC Number: 019348956435 Model Number: DYNJ39198N
  • UPC Number: 019532710200. p. Model Number: DYNJ906086A
  • UPC Number: 019348920868. q. Model Number: DYNJ908260
  • UPC Number: 019532701744. r. Model Number: DYNJ66790

Distribution

Distributed nationwide across the United States.

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