Recall Z-2195-2023 · OFD Catheter Introducer Kit

MEDLINE INDUSTRIES, LP - Northfield

Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) CATHETERLESS INSERTION KIT, Model Number CVI4510; b) VANTEX 7FR 3L 16CM CVC BUNDLE, Model Number STCVC01145B; c) VANTEX TRIPLE LUMEN BUNDLE, Model Number STCVC2000;

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	620 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.