The Recall Desk
HighFDA (Devices)·Z-2324-2023·Announced 2023-08-09

Medline Medical Procedural Kits Recalled for Potential Ultrasound Gel Sterility Failure

Medline Industries recalls 19,907 procedural kits because the sterile ultrasound gel component may not meet sterility specifications.

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: The FDA classified this as a Class II recall. No reported illnesses or injuries are mentioned in the source material. The hazard is potential—the gel may not meet sterility specifications. Per the severity rubric, risk-of-harm products where no injury has been reported score as High (3).

Plain-English summary

Medline Industries, LP is recalling custom sterile and non-sterile procedural kits containing Turkuaz Ultrasound Gel. The recall involves approximately 19,907 kits in multiple configurations, including central line insertion kits, central line tray packs, hemodialysis kits, pediatric line kits, PICC line packs, and laceration trays.

The sterile ultrasound gel component within these kits has the potential to not meet sterility specifications. This creates a risk of exposure to non-sterile products during medical procedures that rely on sterile conditions.

The kits were distributed worldwide, including across the United States and to Canada, China, Costa Rica, India, Lebanon, Panama, Qatar, Saudi Arabia, Singapore, and United Arab Emirates. All lot numbers of the affected models distributed between April 1, 2020 and April 28, 2023 are subject to this recall.

Healthcare facilities and individuals in possession of these kits should immediately discontinue use and contact Medline Industries for information regarding return or replacement. Those who have received these products can verify whether they are affected by checking their model numbers and lot numbers against the recall details.

The recalled product

Product
Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. CENTRAL LINE INSERT KIT W/O CA, Model Number: CVI3755; b. CENTRAL LINE KIT, Model Number: DYNDC2582, DYNDC2582A; c. CENTRAL LINE PACK-COMPANION, Model Num
Manufacturer
MEDLINE INDUSTRIES, LP - Northfield
Category
Medical Device — 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 (19)

  • UPC Number: 019348981943. b. Model Number: DYNDC2582
  • UPC Number: 10889942670444
  • Model Number: DYNDC2582A
  • UPC Number: 10193489198164. c. Model Number: DYNJ47215D
  • UPC Number: 088827774302. d. Model Number: DYNJ42902B
  • UPC Number: 088827779800. e. Model Number: CVI3780
  • UPC Number: 019348943486. f. Model Number: DYNJ83054A
  • UPC Number: 019532731051. g. Model Number: DYNJ47717A
  • UPC Number: 019348945452. h. Model Number: P155508B
  • UPC Number: 019532709134
  • Model Number: P155508C
  • UPC Number: 019532709134. i. Model Number: DYNJ63347
  • UPC Number: 019348981031. j. Model Number: DYNJ47987A
  • UPC Number: 088994268310. k. Model Number: DYNJ38885B
  • UPC Number: 019348946233. l. Model Number: DYNJ60586
  • UPC Number: 019348952804. m. Model Number: DYNDL1134A
  • UPC Number: 008019699476. n. Model Number: DYNJ67990
  • UPC Number: 019348946253. o. Model Number: DYNDV2385
  • UPC Number: 019348947559.

Distribution

Distributed nationwide across the United States.

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