Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) VAD/PICC IV KIT, Model Number DYNDV2200; b) ULTRASOUND PIV KIT, Model Number DYNDV2397; c) VAD ACCESS, Model Number DYNJ24276C; d) FETAL INTERVENTION, Model Number DYNJ66041; e) FETAL INTERVENTION, Model Number DYNJ66041A; f) FETAL INTERVENTION, Model Number DYNJ66041B
This recall is currently active, issued July 20, 2023. It was issued by Medline Industries, Lp - Northfield.
- Recall Initiated
- May 18, 2023
- Posted
- July 20, 2023
- Recall Number
- Z-2187-2023
- Quantity
- 8974 units
- Firm Location
- Northfield, IL
- Official Source
- View on FDA website ↗
Reason for Recall
Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams.
Distribution
Worldwide Distribution: US (Nationwide) and OUS (foreign) United Arab Emirates, Singapore, Lebanon, China Qatar, Costa Rica, India, Canada, Panama & Saudi Arabia.
Lot / Code Info
all lots within expiry, distributed from Medline between December 2017 - May 2023: a) Model Number DYNDV2200, UDI/DI (EA) 10888277742550, UDI/DI (CS) 40888277742551; b) Model Number DYNDV2397, UDI/DI (EA) 10193489388466, UDI/DI (CS) 40193489388467; c) Model Number DYNJ24276C, UDI/DI (EA) 10884389431184, UDI/DI (CS) 40884389431185; d) Model Number DYNJ66041, UDI/DI (EA) 10193489315820, UDI/DI (CS) 40193489315821; e) Model Number DYNJ66041A, UDI/DI (EA) 10193489480283, UDI/DI (CS) 40193489480284; f) Model Number DYNJ66041B, UDI/DI (EA) 10195327151072, UDI/DI (CS) 40195327151073;
Root Cause
Device Design
Action Taken
Medline distributed their recall notices to their consignees beginning on 05/18/2023 by letter. The notices explained the problem, and the risk and requested the destruction of the products. Distributors were directed to notify their consignees, have the customers document and destroy any affected product, and include your customers quantities on the response form. Beginning on 05/23/2023, Medline issued another notice to a separate group of consignees requesting that the kits be over labeled. Distributors were directed to notify the customers and have them return any affected product to the distributor for collection and return to Medline. Questions: please contact the Recall Department at 866-359-1704