The Recall Desk
HighFDA (Devices)·Z-2301-2023·Announced 2023-08-09

Medline Procedural Kits Recalled Due to Potential Sterility Specification Failure

Medline is recalling 41,123 procedural kits containing ultrasound gel that may fail to meet sterility specifications. The kits were distributed to healthcare facilities 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 involving failure to meet sterility specifications in medical device components used in invasive cardiac and vascular procedures. Although no illnesses or injuries have been reported, non-sterile materials in invasive procedures represent significant risk of infection.

Plain-English summary

Medline Industries is recalling 41,123 custom sterile and non-sterile procedural kits containing Turkuaz ultrasound gel. The kits, distributed between April 1, 2020 and April 28, 2023, are used in various medical procedures including electrophysiology, endovascular intervention, cardiac surgery, and vascular procedures.

The ultrasound gel component in the recalled kits has the potential to not meet sterility specifications. This means the gel may be contaminated with microorganisms, which poses a risk of infection when used in sterile surgical or medical procedures.

The affected kits were distributed worldwide to medical facilities in the US, Canada, China, Costa Rica, India, Lebanon, Panama, Qatar, Saudi Arabia, Singapore, and the United Arab Emirates. Hospitals and surgical centers should identify affected products using the model numbers and UPC codes provided in the recall notice.

Healthcare providers should immediately quarantine affected kits and prevent their use in patient procedures. Medline Industries is working with the FDA on this recall. Affected facilities should contact Medline for replacement products or return instructions.

The recalled product

Product
Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. ELECTROPHYSIOLOGY PACK-LF, Model Number: DYNJ0842825D; b. EMANUEL EP TRAY, Model Number: DYNJ49933I, DYNJ49933J; c. ENDO LASER ABLATION PK-LF, Model Number: DYN
Manufacturer
MEDLINE INDUSTRIES, LP - Northfield
Category
Medical Device — Procedural Kit
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: 019532728861. b. Model Number: DYNJ49933I
  • UPC Number: 019348947168
  • Model Number: DYNJ49933J
  • UPC Number: 019532706561. c. Model Number: DYNJ44808G
  • UPC Number: 019348987585. d. Model Number: DYNJ51304B
  • UPC Number: 088994236595
  • Model Number: DYNJ51304C
  • UPC Number: 019348946098. e. Model Number: DYNJ0678934D
  • UPC Number: 019348956435
  • Model Number: DYNJ0678934F
  • Model Number: DYNJ82567
  • UPC Number: 019532719803. f. Model Number: DYNJ0676055N
  • UPC Number: 019348956435. g. Model Number: DYNJ63343A
  • UPC Number: 019348929199
  • Model Number: DYNJ63343B
  • UPC Number: 019348947045
  • Model Number: DYNJ63343D
  • UPC Number: 019348996760
  • Model Number: DYNJ63343F
  • UPC Number: 019532708613

Distribution

Distributed nationwide across the United States.

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