Medline Ultrasound Probe Cover Kits Recalled for Inadequate Seam Barrier
Medline has recalled approximately 3.7 million ultrasound probe cover kits due to inadequate barriers at the seams that could affect sterile field integrity during diagnostic procedures.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 Class II FDA recall affects sterile barrier products used in invasive diagnostic and interventional procedures. The inadequate seams pose a risk of contamination and compromise of the sterile field. No illnesses or injuries have been reported, making this a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Medline Industries, LP has recalled approximately 3.7 million ultrasound probe cover kits containing sterile ultrasound gel due to an inadequate barrier at the seams. The kits are labeled under numerous product names and model numbers used in diagnostic ultrasound procedures.
The defect involves inadequate sealing at the kit seams, which could compromise the integrity of the sterile barrier during use. This Class II recall affects products distributed worldwide from December 2017 through May 2023.
The recalled kits were distributed in the United States and internationally, including United Arab Emirates, Singapore, Lebanon, China, Qatar, Costa Rica, India, Canada, Panama, and Saudi Arabia. The products are used in various diagnostic and interventional ultrasound procedures.
Healthcare facilities and practitioners with these recalled kits should discontinue use and contact Medline Industries for replacement units.
The recalled product
- Product
- Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) NO-CATH RADIAL ARTERIAL PREMIU, Model Number ARTNC115; b) MAJOR VASCULAR, Model Number CDS980752I; c) PICC LINE DOUBLE LUMEN CDS, Model Number CDS982858F; d) PICC LINE TRIPLE LUMEN CDS…
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Affected units
- 3,740,814
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) 10653160354338
- UDI/DI (CS) 40653160354339
- b) Model Number CDS980752I
- UDI/DI (EA) 10889942428540
- UDI/DI (CS) 40889942428541
- c) Model Number CDS982858F
- UDI/DI (EA) 10888277739215
- UDI/DI (CS) 40888277739216
- d) Model Number CDS982859F
- UDI/DI (EA) 10888277739208
- UDI/DI (CS) 40888277739209
- e) Model Number CDS983082J
- UDI/DI (EA) 10193489674514
- UDI/DI (CS) 40193489674515
- f) Model Number CDS983704I
- UDI/DI (EA) 10193489854558
- UDI/DI (CS) 40193489854559
- g) Model Number CVI4340
- UDI/DI (EA) 10653160309475
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.
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