The Recall Desk
HighFDA (Devices)·Z-2197-2023·Announced 2023-07-26

Medline Probe Cover Kits recalled for inadequate barrier at seams

Medline is recalling Probe Cover Kits (Model MNS10750A) used in diagnostic ultrasound procedures because the probe covers may have an inadequate barrier at the seams, potentially affecting protective effectiveness.

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 a Class II medical device recall involving a structural defect in a product used during diagnostic procedures. No illnesses, injuries, or deaths have been reported in the source material. Per the rubric, risk-of-harm products where injury has not yet been reported score at 3 (High).

Plain-English summary

Medline Industries is recalling Probe Cover Kits (Model Number MNS10750A), which contain sterile Ultrasound Gel and are labeled as Dialysis Accessory Pack w/o Catheter. These kits were distributed worldwide from December 2017 through May 2023.

The probe covers used during diagnostic ultrasound procedures may have an inadequate barrier at the seams. This structural defect could compromise the protective effectiveness of the covers during medical procedures.

The affected kits have been distributed to 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 and are included in the recall.

Users and healthcare facilities should immediately discontinue use of the affected kits and contact Medline Industries. Affected products can be identified by Model Number MNS10750A and UDI codes 10653160356073 (EA) or 00653160356076 (CS).

The recalled product

Product
Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: DIALYSIS ACCESSORY PACK W/O CATHETER, Model Number MNS10750A
Manufacturer
MEDLINE INDUSTRIES, LP - Northfield
Category
Medical Device — Ultrasound Equipment
Hazard
  • barrier-defect
  • 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 (3)

  • All lots within expiry
  • UDI/DI (EA) 10653160356073
  • UDI/DI (CS) 00653160356076

Distribution

Distributed nationwide across the United States.

Related recalls

Same category