Medline Probe Cover Kits containing sterile Ultrasound recall
Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) BLOCK SUPPLIES NDL CNTR, Model Number DYNJRA1755; b) VNUS…
Why was Medline Probe Cover Kits containing sterile Ultrasound recalled?
Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
all lots within expiry, distributed from Medline between December 2017 - May 2023: a) Model Number DYNJRA1755, UDI/DI (EA) 10193489842845, UDI/DI (CS) 40193489842846; b) Model Number DYNJTESTCFP4, UDI/DI (EA) 10193489472813, UDI/DI (CS) 40193489472814; c) Model Number IV8635D, UDI/DI (EA) 10653160990260, UDI/DI (CS) 40653160990261; d) Model Number IVS3300, UDI/DI (EA) 10653160307662, UDI/DI (CS) 40653160307663; e) Model Number IVS3485A, UDI/DI (EA) 10653160990154, UDI/DI (CS) 40653160990155; f) Model Number IVS3825, UDI/DI (EA) 10653160330752, UDI/DI (CS) 40653160330753; g) Model Number IVS3840A, UDI/DI (EA) 10193489476736, UDI/DI (CS) 40193489476737; h) Model Number MNS11625, UDI/DI (EA) 10653160322139, UDI/DI (CS) 40653160322130; i) Model Number MNS7695A, UDI/DI (EA) 10653160343455, UDI/DI (CS) 40653160343456; j) Model Number NG410A, UDI/DI (EA) 10889942945887, UDI/DI (CS) 40889942945888; k) Model Number PHS41739A, UDI/DI (EA) 10889942906802, UDI/DI (CS) 40889942906803; l) Model Number PHS479840M, UDI/DI (EA) 10193489682724, UDI/DI (CS) 40193489682725; m) Model Number SYNJ10303B, UDI/DI (EA) 10193489373745, UDI/DI (CS) 40193489373746; n) Model Number TVS4500A, UDI/DI (EA) 10816982023374, UDI/DI (CS) 40816982023375; o) Model Number TVS4500B, UDI/DI (EA) 10195327223564, UDI/DI (CS) 40195327223565; p) Model Number VC-PK, UDI/DI (EA) 10195327176891, UDI/DI (CS) 40195327176892;
- Product
- Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) BLOCK SUPPLIES NDL CNTR, Model Number DYNJRA1755; b) VNUS…
- Recalling firm
- MEDLINE INDUSTRIES, LP - Northfield
- Quantity
- # included in 3,740,814 units total
- Distribution
- Worldwide Distribution: US (Nationwide) and OUS (foreign) United Arab Emirates, Singapore, Lebanon, China Qatar, Costa Rica, India, Canada, Panama & Saudi Arabia.
- Recall date
- July 26, 2023
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)