The Recall Desk
HighFDA (Devices)·Z-2200-2023·Announced 2023-07-26

Medline Ultrasound Probe Covers Recalled for Inadequate Seam Barrier

Medline Industries is recalling 70,648 ultrasound probe cover kits used in diagnostic and interventional procedures due to inadequate barriers at the seams.

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 medical device recall with a structural defect (inadequate barrier at seams) in products used during invasive procedures requiring sterile barriers. No illnesses, injuries, or hospitalizations have been reported, making this a risk-of-harm situation where the potential for adverse effects exists but has not yet manifested.

Plain-English summary

Medline Industries is recalling multiple models of ultrasound probe cover kits that contain sterile ultrasound gel. These kits are used as protective barriers during diagnostic and interventional ultrasound procedures, including arterial line insertion, peripheral intravenous (PIV) placement, and central line insertion procedures.

The probe covers may have an inadequate barrier at the seams. This defect could potentially affect the protective function of the covers during procedures where sterility is critical.

A total of 70,648 units are affected by this recall. The products were distributed worldwide between December 2017 and May 2023 to healthcare facilities in the United States and internationally, including the United Arab Emirates, Singapore, Lebanon, China, Qatar, Costa Rica, India, Canada, Panama, and Saudi Arabia. All affected lots remain within their expiration dates.

Healthcare facilities that have received these probe cover kits should immediately cease using them and contact Medline Industries for guidance on replacement or disposal. Consult the FDA's official recall notice (Z-2200-2023) for complete details and further instructions.

The recalled product

Product
Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) ARTERIAL LINE START KIT , Model Number ART920; b) ULTRASOUND GUIDED PIV KIT , Model Number BSIPIV1005; c) ULTRASOUND GUIDED IV START KIT W/SHIELD , Model Number BSIPIV1006; d) PIV BSI
Manufacturer
MEDLINE INDUSTRIES, LP - Northfield
Category
Medical Device — Ultrasound / Probe Covers
Hazard
  • barrier-defect
  • contamination

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) 10653160327899
  • UDI/DI (CS) 00653160327892
  • b) Model Number BSIPIV1005
  • UDI/DI (EA) 10193489198867
  • UDI/DI (CS) 20193489198864
  • c) Model Number BSIPIV1006
  • UDI/DI (EA) 10653160356936
  • UDI/DI (CS) 00653160356939
  • d) Model Number BSIPIV1010
  • UDI/DI (EA) 10653160356523
  • UDI/DI (CS) 00653160356526
  • e) Model Number BSIPIV1011
  • UDI/DI (EA) 10653160353317
  • UDI/DI (CS) 00653160353310
  • f) Model Number CVI3805
  • UDI/DI (EA) 10653160265085
  • UDI/DI (CS) 00653160265088
  • g) Model Number CVI4450B
  • UDI/DI (EA) 10653160358428

Distribution

Distributed nationwide across the United States.

Related recalls

Same category