Recall Z-2196-2023 · OJF Hysterectomy Kit

MEDLINE INDUSTRIES, LP - Northfield

Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) VNUS TRAY, Model Number DYNJ44410G; b) INTRAUTERINE TRNSFUSION -LF, Model Number DYNJ9048708I; c) PERI NEURO BLOCK PACK-LF, Model Number PHS762887001B; d) TVS4700 CUSTOM PACK, Model Number TVS4700;

Date	Jul 20, 2023 (initiated May 18, 2023)
Status	Open, Classified
Reason	Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams.
Root cause	Device Design
Action	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
Quantity	2420 units
Distribution	Worldwide Distribution: US (Nationwide) and OUS (foreign) United Arab Emirates, Singapore, Lebanon, China Qatar, Costa Rica, India, Canada, Panama & Saudi Arabia.
FDA record	Open on fda.gov

510(k) clearances named in this recall

This recall record lists no 510(k) number.