Medline Probe Cover Kits containing sterile Ultrasound recall
Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) CVC INFANT INSERTION PACK, Model Number CVI4770A; b) INSERTION BUNDLE, Model Number DT21275; c) VA MAINTENANCE PACK, Model Number EBSI1382; d) MIDLINE DRESSING CHANGE KIT, Model Number EBSI1464;
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 CVI4770A, UDI/DI (EA) 10653160350828, UDI/DI (CS) 00653160350821; b) Model Number DT21275, UDI/DI (EA) 10653160318934, UDI/DI (CS) 00653160318937; c) Model Number EBSI1382, UDI/DI (EA) 10193489196269, UDI/DI (CS) 20193489196266; d) Model Number EBSI1464, UDI/DI (EA) 10193489198959, UDI/DI (CS) 20193489198956;
- Product
- Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) CVC INFANT INSERTION PACK, Model Number CVI4770A; b) INSERTION BUNDLE, Model Number DT21275; c) VA MAINTENANCE PACK, Model Number EBSI1382; d) MIDLINE DRESSING CHANGE KIT, Model Number EBSI1464;
- Recalling firm
- MEDLINE INDUSTRIES, LP - Northfield
- Quantity
- 572 units
- 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)