The Recall Desk
HighFDA (Devices)·Z-2196-2023·Announced 2023-07-26

Medline Probe Cover Kits recalled for inadequate seam barriers

Medline is recalling probe cover kits used in ultrasound procedures due to potential inadequate barriers at the seams that could affect product protection.

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. The identified defect—inadequate seam barriers—is a theoretical hazard that creates a risk-of-harm scenario. Per the rubric, this fits High severity as a risk-of-harm product where no injuries have been reported.

Plain-English summary

Medline Industries, LP is recalling Probe Cover Kits containing sterile ultrasound gel distributed under multiple model numbers. Affected models include the VNUS TRAY (Model DYNJ44410G), Intrauterine Transfusion-LF (Model DYNJ9048708I), Peri Neuro Block Pack-LF (Model PHS762887001B), and TVS4700 Custom Pack (Model TVS4700). Approximately 2,420 units were distributed.

The probe covers may have an inadequate barrier at the seams, which could compromise the protective function of the covers during diagnostic ultrasound procedures.

The affected kits were distributed from December 2017 through May 2023 across the United States and internationally to the United Arab Emirates, Singapore, Lebanon, China, Qatar, Costa Rica, India, Canada, Panama, and Saudi Arabia.

Healthcare providers and facilities in possession of affected units should contact Medline for information regarding product returns or replacements.

The recalled product

Product
Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) VNUS TRAY, Model Number DYNJ44410G; b) INTRAUTERINE TRNSFUSION -LF, Model Number DYNJ9048708I; c) PERI NEURO BLOCK PACK-LF, Model Number PHS762887001B; d) TVS4700 CUSTOM PACK, Model Nu
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 (8)

  • All lots within expiry
  • UDI/DI (CS)40193489958448
  • b) Model Number DYNJ9048708I. UDI/DI (EA)10195327072735
  • UDI/DI (CS)40195327072736
  • c) Model Number PHS762887001B. UDI/DI (EA)10889942849314
  • UDI/DI (CS) 40889942849315
  • d) Model Number TVS4700. UDI/DI (EA)10816982023398
  • UDI/DI (CS)40816982023399

Distribution

Distributed nationwide across the United States.

Related recalls

Same category