The Recall Desk
HighFDA (Devices)·Z-2181-2023·Announced 2023-07-26

Medline Probe Cover Kits Recalled for Inadequate Seam Barriers

Medline is recalling probe cover kits with ultrasound gel due to inadequate barriers at the seams that 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: This FDA Class II recall involves a structural defect in a medical device's sterility barrier. The inadequate seam barrier poses a risk of contamination during patient procedures, meeting the rubric criterion of 'risk-of-harm products where injury has not yet been reported.' Class II recalls without reported hospitalizations score at most 3.

Plain-English summary

Medline Industries, LP is recalling probe cover kits containing sterile ultrasound gel. The affected products were distributed worldwide between December 2017 and May 2023 and include 16 model variations used in diagnostic ultrasound procedures. Approximately 3,740,814 units were distributed to healthcare facilities in the United States and multiple countries worldwide.

The probe covers may have an inadequate barrier at the seams. An inadequate barrier compromises the sterility assurance of the product and may result in contamination during ultrasound-guided medical procedures.

Healthcare providers and facilities with affected products should discontinue use and contact Medline Industries or the FDA for return and replacement instructions.

The recalled product

Product
Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) BLOCK SUPPLIES NDL CNTR, Model Number DYNJRA1755; b) VNUS TEST KIT CFP-LF, Model Number DYNJTESTCFP4; c) ULTRASOUND PIV BUNDLE, Model Number IV8635D; d) ULTRASOUND GUIDED PIV KIT, Model
Manufacturer
MEDLINE INDUSTRIES, LP - Northfield
Category
Medical Device — Diagnostic Imaging / Ultrasound Equipment
Hazard
  • inadequate-barrier
  • contamination-risk
  • sterility-compromise

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)

  • all lots within expiry
  • UDI/DI (EA) 10193489842845
  • UDI/DI (CS) 40193489842846
  • b) Model Number DYNJTESTCFP4
  • UDI/DI (EA) 10193489472813
  • UDI/DI (CS) 40193489472814
  • c) Model Number IV8635D
  • UDI/DI (EA) 10653160990260
  • UDI/DI (CS) 40653160990261
  • d) Model Number IVS3300
  • UDI/DI (EA) 10653160307662
  • UDI/DI (CS) 40653160307663
  • e) Model Number IVS3485A
  • UDI/DI (EA) 10653160990154
  • UDI/DI (CS) 40653160990155
  • f) Model Number IVS3825
  • UDI/DI (EA) 10653160330752
  • UDI/DI (CS) 40653160330753
  • g) Model Number IVS3840A
  • UDI/DI (EA) 10193489476736

Distribution

Distributed nationwide across the United States.

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