The Recall Desk
HighFDA (Devices)·Z-2300-2023·Announced 2023-08-09

Medline Procedural Kits Recalled for Potential Sterility Defect in Ultrasound Gel

Medline Industries is recalling custom procedural kits because the ultrasound gel component may not meet sterility specifications. The kits were distributed nationwide and internationally from 2020 to 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 concerning potential sterility defects in the gel component of surgical procedural kits. Although no illnesses or injuries have been reported, the use of non-sterile gel in sterile surgical procedures poses a risk of patient harm through infection.

Plain-English summary

Medline Industries, LP is recalling 46,124 custom sterile and non-sterile procedural kits containing Turkuaz Ultrasound Gel. The kits include multiple model numbers used in cardiovascular, vascular, and other surgical procedures.

The ultrasound gel component in the affected kits may not meet sterility specifications. The use of non-sterile gel in sterile surgical procedures could introduce contamination risk.

The kits were distributed worldwide from April 1, 2020, through April 28, 2023, to locations including the United States, Canada, China, Costa Rica, India, Lebanon, Panama, Qatar, Saudi Arabia, Singapore, and the United Arab Emirates. A complete list of affected model numbers and corresponding UPC codes is available from the FDA.

Affected model numbers span multiple product lines including AAA Pack, Abdominal Vascular, Ablation Pack, Open Heart, Cardiac, Carotid, and Vascular packs. Healthcare facilities receiving these kits should verify their inventory against the recalled model numbers and UPC codes.

The recalled product

Product
Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. AAA PACK, Model Number: DYNJ44847I; b. ABDOMINAL VASCULAR PACK, Model Number: DYNJ82578; c. ABDOMINAL VASCULAR-LF, Model Numbers: DYNJ905291B, DYNJ905291C; d.
Manufacturer
MEDLINE INDUSTRIES, LP - Northfield
Category
Medical Device — Procedural Kits / Ultrasound Gel
Hazard
  • sterility-defect
  • 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: 019532712755. b. Model Number: DYNJ82578
  • UPC Number: 019532719814. c. Model Number: DYNJ905291B
  • UPC Number: 019348995037
  • Model Number: DYNJ905291C
  • UPC Number: 019532706254. d. Model Number: DYNJ61957A
  • UPC Number: 019348969907. e. Model Number: DYNJ36600F
  • UPC Number: 088994255256. f. Model Number: DYNJV0275J
  • UPC Number: 019348926312
  • Model Number: DYNJV0275K
  • Model Number: DYNJV0275L
  • Model Number: DYNJV0275M
  • UPC Number: 019532701862. g. Model Number: DYNJ69682
  • UPC Number: 019348996892. h. Model Number: CDS840493F
  • UPC Number: 019348964363. i. Model Number: DYNJ24272C
  • UPC Number: 019348962022. j. Model Number: DYNJ905290D
  • UPC Number: 019532706253. k. Model Number: DYNDC3038
  • UPC Number: 019348949360. l. Model Number: DYNJ81636
  • UPC Number: 019532712918
  • Model Number: DYNJ81636A
  • UPC Number: 019532724491. m. Model Number: DYNJ83051

Distribution

Distributed nationwide across the United States.

Related recalls

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