The Recall Desk
HighFDA (Devices)·Z-2199-2023·Announced 2023-07-26

Medline probe cover kits recalled for inadequate seam barrier protection

Medline probe cover kits used in diagnostic ultrasound procedures are being recalled due to inadequate barriers at the seams, which may compromise sterile integrity during use. A total of 39,391 units are affected.

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 for medical device probe covers with an inadequate seam barrier. No illnesses or injuries have been reported. The hazard is a theoretical contamination risk due to barrier failure, qualifying it as a High-severity risk-of-harm product without reported harm per the established rubric.

Plain-English summary

Medline Industries is recalling probe cover kits containing sterile ultrasound gel across 40+ model numbers used for diagnostic and procedural ultrasound applications, including arterial line placement, PICC insertion, biopsy procedures, and vascular access insertion. The recall affects 39,391 units.

The probe covers may have inadequate barriers at the seams. This barrier deficiency could allow contamination to occur during ultrasound procedures, compromising the sterile integrity of the product.

The affected kits were distributed worldwide from December 2017 through May 2023. Distribution included the United States and international locations such as Canada, Singapore, India, the United Arab Emirates, China, and others.

Healthcare providers and facilities that have received these recalled kits should discontinue use and contact Medline Industries for return or replacement instructions.

The recalled product

Product
Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) FEMORAL ARTERIAL LINE BUNDLE, Model Number ART1005; b) 20GX6" FEMORAL ART LINE KIT, Model Number ART1165; c) 3" RADIAL ARTERIAL LINE KIT, Model Number ART240A; d) 6" FEMORAL ARTERIAL
Manufacturer
MEDLINE INDUSTRIES, LP - Northfield
Category
Medical Device
Hazard
  • inadequate-barrier
  • 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 (20)

  • All lots within expiry
  • UDI/DI (EA) 10193489198232
  • UDI/DI (CS) 20193489198239
  • b) Model Number ART1165
  • UDI/DI (EA) 10653160354680
  • UDI/DI (CS) 00653160354683
  • c) Model Number ART240A
  • UDI/DI (EA) 10653160328025
  • UDI/DI (CS) 00653160328028
  • d) Model Number ART245A
  • UDI/DI (EA) 10653160328018
  • UDI/DI (CS) 00653160328011
  • e) Model Number ART245B
  • UDI/DI (EA) 10653160358442
  • UDI/DI (CS) 00653160358445
  • f) Model Number ART255
  • UDI/DI (EA) 10653160311997
  • UDI/DI (CS) 00653160311990
  • g) Model Number ART560
  • UDI/DI (EA) 10653160310822

Distribution

Distributed nationwide across the United States.

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