Medline Probe Cover Kits containing sterile Ultrasound recall
Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) ULTRASOUND PACK, Model Number DYNDH1112; b) PARA THORACENTESIS TRAY, Model Number DYNDH1165A; c) ULTRASOUND TRAY, Model Number DYNDH1204;
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 DYNDH1112, UDI/DI (EA) 10889942277360, UDI/DI (CS) 40889942277361; b) Model Number DYNDH1165A, UDI/DI (EA) 10889942611508, UDI/DI (CS) 40889942611509; c) Model Number DYNDH1204, UDI/DI (EA) 10889942519835, UDI/DI (CS) 40889942519836
- Product
- Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) ULTRASOUND PACK, Model Number DYNDH1112; b) PARA THORACENTESIS TRAY, Model Number DYNDH1165A; c) ULTRASOUND TRAY, Model Number DYNDH1204;
- Recalling firm
- MEDLINE INDUSTRIES, LP - Northfield
- Quantity
- 575 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)