High FDA (Devices)·Z-2163-2023·Announced 2023-07-26

Medline Ultrasound Probe Covers Recalled for Inadequate Seam Barriers

Medline is recalling 172,722 ultrasound probe cover kits due to inadequate barrier protection at the seams. The defect may compromise protective function 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 medical device recall for inadequate barrier protection on ultrasound probe covers. No illnesses or injuries have been reported. Per the rubric, this qualifies as a risk-of-harm product where injury has not yet been reported, resulting in a High severity score.

Plain-English summary

Medline Industries, LP is recalling probe cover kits containing sterile ultrasound gel used during diagnostic ultrasound procedures. The affected units may have an inadequate barrier at the seams, which could compromise the protective function of the covers.

The recall affects approximately 172,722 units across multiple model numbers and branded configurations. The products were distributed worldwide between December 2017 and May 2023 to the United States and international locations including the United Arab Emirates, Singapore, Lebanon, China, Qatar, Costa Rica, India, Canada, Panama, and Saudi Arabia.

Healthcare facilities have been notified of the recall. Specific model numbers, UDI codes, and detailed distribution information are available in the official FDA recall notice.

The recalled product

Product: Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a. NORTON CHILDRENS CATH LAB-LF, Model Number 00-401185Q; b. PERCUTANEOUS VASCULAR CDS, Model Number CDS840487I; c. BAPTIST SOUTH OPEN HEART CV PK, Model Number CDS983147I; d. ENDOVASCULAR
Manufacturer: MEDLINE INDUSTRIES, LP - Northfield
Category: Medical Device — Ultrasound Probe Cover
Hazard: barrier-failure
contamination-risk
Affected units: 172,722

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) 10193489489088
UDI/DI (CS)40193489489089
b) Model Number CDS840487I
UDI/DI (EA) 10193489445343
UDI/DI (CS)40193489445344
c) Model Number CDS983147I
UDI/DI (EA) 10195327075514
UDI/DI (CS)40195327075515
d) Model Number CDS983394I
UDI/DI (EA) 10193489819953
UDI/DI (CS)40193489819954
e) Model Number CDS983394J
UDI/DI (EA) 10195327069872
UDI/DI (CS)40195327069873
f) Model Number CDS983394K
UDI/DI (EA) 10195327292584
UDI/DI (CS)40195327292585
g) Model Number CDS983513F
UDI/DI (EA) 10193489843729

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 52 recalled by MEDLINE INDUSTRIES, LP - Northfield under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 52 products in this recall →

Same manufacturer · MEDLINE INDUSTRIES, LP - Northfield

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