The Recall Desk
HighFDA (Devices)·Z-2182-2023·Announced 2023-07-26

Medline Probe Cover Kits Recalled Due to Inadequate Seam Barrier

Medline is recalling Probe Cover Kits (Models CVI4325 and DT13351A) distributed worldwide from December 2017 to May 2023. The probe covers may have inadequate barrier protection at the seams, posing a contamination risk 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: FDA Class II recalls without reported adverse events typically score at 3. The product—probe covers with inadequate seam barriers—poses a risk of contamination during sterile diagnostic procedures, but no illnesses or injuries have been reported to date, limiting the severity to High (3) rather than Severe.

Plain-English summary

Medline Industries, LP is recalling Probe Cover Kits containing sterile ultrasound gel, specifically Model Numbers CVI4325 (Universal Insertion Tray) and DT13351A (PPE Bundle Kit). A total of 1,380 units have been distributed worldwide.

The probe covers may have an inadequate barrier at the seams, which could compromise their ability to prevent contamination during diagnostic ultrasound procedures. This is a Class II recall.

The affected product was distributed from December 2017 through May 2023 to facilities in the United States and internationally, including the United Arab Emirates, Singapore, Lebanon, China, Qatar, Costa Rica, India, Canada, Panama, and Saudi Arabia. Healthcare providers and facilities using these products should discontinue use and contact Medline Industries for further instructions or replacement products.

The recalled product

Product
Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) UNIVERSAL INSERTION TRAY, Model Number CVI4325; b) PPE BUNDLE KIT, Model Number DT13351A
Manufacturer
MEDLINE INDUSTRIES, LP - Northfield
Category
Medical Device — Diagnostic Equipment
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 (6)

  • all lots within expiry
  • UDI/DI (EA) 10653160307037
  • UDI/DI (CS) 40653160307038
  • b) Model Number DT13351A
  • UDI/DI (EA) 10653160325581
  • UDI/DI (CS) 40653160325582

Distribution

Distributed nationwide across the United States.

Related recalls

Same category