The Recall Desk
HighFDA (Devices)·Z-2306-2023·Announced 2023-08-09

Medline procedural kits recalled for potential sterility failure in ultrasound gel

Medline Industries is recalling 148,445 procedural kits containing Turkuaz Ultrasound Gel over potential sterility failure of the gel component, which could lead to infections if used in sterile 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 involving potential sterility failure in a high-risk medical device component used in sterile surgical and vascular procedures. Although no illnesses or injuries have been reported and the hazard is potential rather than confirmed, sterile procedural kits are risk-of-harm products where non-sterile components could result in serious infections.

Plain-English summary

Medline Industries, LP is recalling 148,445 custom sterile and non-sterile procedural kits containing Turkuaz Ultrasound Gel due to a potential sterility failure in the gel component. The affected kits include multiple models used for vascular access, vein procedures, and other surgical applications, distributed between April 2020 and April 2023.

The ultrasound gel component within these procedural kits may not meet sterility specifications. While no injuries or illnesses have been reported, use of non-sterile gel in sterile procedures could increase the risk of infection.

The recalled 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 and providers who have received these kits should stop using them immediately. Check the product model numbers and lot numbers against the recall information available on the FDA website. Contact Medline Industries with questions about the recall or return of affected products.

The recalled product

Product
Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. SHY IR PICC PACK, Model Number: DYNJ57112; b. STANDARD PICC II-LF, Model Number: DYNJSPICC2, PICCNC002; c. SUPERFICAL VENOUS PROCEDURE, Model Number: DYNJ
Manufacturer
MEDLINE INDUSTRIES, LP - Northfield
Category
Medical Device — Surgical procedural kits
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 (20)

  • UPC Number: 088994272159. b. Model Number: DYNJSPICC2
  • UPC Number: 019348926312
  • Model Number: PICCNC002
  • UPC Number: 019348987719. c. Model Number: DYNJ82989
  • UPC Number: 019532722176. d. Model Number: DYNJ81267
  • UPC Number: 019532710144. e. Model Number: DYNJ41561D
  • UPC Number: 088994281163. f. Model Number: IVS3635A
  • UPC Number: 019348936055. g. Model Number: DYNDA2669
  • UPC Number: 019348946542. h. Model Number: DYNDV2480
  • UPC Number: 019348994276. i. Model Number: DYNJ907965
  • UPC Number: 019348995225. j. Model Number: DYNJ901340A
  • UPC Number: 088994217977. k. Model Number: DYNJ52606B
  • UPC Number: 088827776311. l. Model Number: DYNJ905285D
  • UPC Number: 019532706266. m. Model Number: DYNJ37445G
  • UPC Number: 019348956435. n. Model Number: DYNJ66356F
  • UPC Number: 019532716001. o. Model Number: DYNJ69769
  • UPC Number: 019348997779. p. Model Number: DYNJ63268C
  • UPC Number: 019532707716
  • Model Number: DYNJ63268D
  • UPC Number: 019532713221

Distribution

Distributed nationwide across the United States.

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