The Recall Desk
HighFDA (Devices)·Z-2183-2023·Announced 2023-07-26

Medline Ultrasound Probe Cover Kits Recalled for Seam Defects

Medline is recalling ultrasound probe cover kits containing sterile ultrasound gel due to an inadequate seam barrier. The defect may compromise sterility during diagnostic ultrasound 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: FDA Class II recall involving a structural defect in a sterile medical device used during invasive diagnostic procedures. Meets criteria for risk-of-harm product where no illnesses or injuries have been reported in the source text.

Plain-English summary

Medline Industries, LP is recalling approximately 35,717 ultrasound probe cover kits containing sterile ultrasound gel. The affected products include the IV Securement Kit (Model DYNDV2407A), USG IV Start Kit (Model DYNDV2435), Ultrasound Guided IV Start Kit (Model DYNDV2518), and VI Pack (Model DYNJ64871).

The probe covers may have an inadequate barrier at the seams. This defect could potentially compromise the integrity of the barrier during diagnostic ultrasound procedures.

The affected products were distributed worldwide, including in the United States and internationally to the United Arab Emirates, Singapore, Lebanon, China, Qatar, Costa Rica, India, Canada, Panama, and Saudi Arabia. All lots were distributed between December 2017 and May 2023.

Healthcare facilities and individuals who possess these products should discontinue use and contact Medline Industries for replacement or disposal instructions.

The recalled product

Product
Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) IV SECUREMENT KIT, Model Number DYNDV2407A; b) USG IV START KIT, Model Number DYNDV2435; c) ULTRASOUND GUIDED IV START KIT, Model Number DYNDV2518; d) VI PACK, Model Number DYNJ64871
Manufacturer
MEDLINE INDUSTRIES, LP - Northfield
Category
Medical Device — Diagnostic Ultrasound
Hazard
  • seal-integrity
  • contamination-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 (8)

  • all lots within expiry
  • UDI/DI (EA) 10193489817010UDI/DI (CS) 40193489817011
  • b) Model Number DYNDV2435
  • UDI/DI (EA) 10195327043667UDI/DI (CS) 40195327043668
  • c) Model Number DYNDV2518
  • UDI/DI (EA) 10195327089078UDI/DI (CS) 40195327089079
  • d) Model Number DYNJ64871
  • UDI/DI (EA) 10193489225365UDI/DI (CS) 40193489225366

Distribution

Distributed nationwide across the United States.

Related recalls

Same category