The Recall Desk
HighFDA (Devices)·Z-2193-2023·Announced 2023-07-26

Medline Probe Cover Kits Recalled for Inadequate Seam Barriers

Medline is recalling probe cover kits containing sterile ultrasound gel due to inadequate barriers at the seams, which may compromise sterility during diagnostic ultrasound procedures. The recall affects 2,590 units distributed worldwide between December 2017 and May 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: FDA Class II recall of a medical device with a manufacturing defect (inadequate seam barrier) that poses risk to patient safety through potential sterility compromise during invasive diagnostic procedures. No reported illnesses or injuries have been documented.

Plain-English summary

Medline Industries, LP is recalling multiple models of probe cover kits containing sterile ultrasound gel used during diagnostic ultrasound procedures. The affected models are ART1070A, ART1160, ART1180, ART775B, ART890A, ART995, and P42453.

The recall is due to an inadequate barrier at the seams of the probe covers. This manufacturing defect may compromise the sterility and barrier function of the covers during use in diagnostic ultrasound procedures.

The affected product was distributed worldwide, including to healthcare facilities in the United States, United Arab Emirates, Singapore, Lebanon, China, Qatar, Costa Rica, India, Canada, Panama, and Saudi Arabia. All affected lots remain within their expiration dates and were distributed between December 2017 and May 2023.

Healthcare providers who have these products should discontinue use and contact Medline Industries, LP or consult appropriate guidance from their healthcare facility for disposal and replacement instructions.

The recalled product

Product
Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) RADIAL ARTERIAL LINE KIT, Model Number ART1070A; b) ARTERIAL LINE START KIT, Model Number ART1160; c) ARTERIAL LINE TRAY W/O CATHETER, Model Number ART1180; d) ARTERIAL LINE INSERTION
Manufacturer
MEDLINE INDUSTRIES, LP - Northfield
Category
Medical Device — Diagnostic Ultrasound
Hazard
  • barrier-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 (20)

  • all lots within expiry
  • UDI/DI EA 10653160358329
  • UDI/DI CS 00653160358322
  • b) Model Number ART1160
  • UDI/DI EA 10653160355762
  • UDI/DI CS 00653160355765
  • c) Model Number ART1180
  • UDI/DI EA 10653160355472
  • UDI/DI CS 00653160355475
  • d) Model Number ART775B
  • UDI/DI EA 10653160353560
  • UDI/DI CS 00653160353563
  • e) Model Number ART890A
  • UDI/DI EA 10653160356677
  • UDI/DI CS 00653160356670
  • f) Model Number ART995
  • UDI/DI EA 10193489190502
  • UDI/DI CS 20193489190509
  • g) Model Number P42453
  • UDI/DI EA 10653160323792

Distribution

Distributed nationwide across the United States.

Related recalls

Same category