Medline Probe Cover Kits containing sterile Ultrasound recall
Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) LACERATION TRAY, Model Number DYNDL1134A; b) ULTRASOUND…
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 DYNDL1134A, UDI/DI (EA) 10080196994762, UDI/DI (CS)40080196994763; b) Model Number DYNDV2385, UDI/DI (EA) 10193489475593, UDI/DI (CS)40193489475594; c) Model Number DYNJ38885B, UDI/DI (EA) 10193489462333, UDI/DI (CS)40193489462334; d) Model Number DYNJ42902B, UDI/DI (EA) 10888277798007, UDI/DI (CS)40888277798008; e) Model Number DYNJ47215D, UDI/DI (EA) 10888277743021, UDI/DI (CS)40888277743022; f) Model Number DYNJ47717A, UDI/DI (EA) 10193489454529, UDI/DI (CS)40193489454520; g) Model Number DYNJ60586, UDI/DI (EA) 10193489528046, UDI/DI (CS)40193489528047; h) Model Number DYNJ67990, UDI/DI (EA) 10193489462531, UDI/DI (CS)40193489462532; i) Model Number DYNJ83054A, UDI/DI (EA) 10195327310516, UDI/DI (CS)40195327310517
- Product
- Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) LACERATION TRAY, Model Number DYNDL1134A; b) ULTRASOUND…
- Recalling firm
- MEDLINE INDUSTRIES, LP - Northfield
- Quantity
- 11413 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)