Recall Z-1051-2023— Bard Peripheral Vascular Inc

Name: FDA recall Z-1051-2023
Creator: U.S. Food and Drug Administration
Published: 2023-01-04

Class II · Ongoing

Class II FDA medical device recall by Bard Peripheral Vascular Inc, initiated 2023-01-04. It names 2 FDA 510(k) clearances: K871998, K830406. Product: Catalog Number / Product Description 0601600 2.7F Broviac CV Catheter Repair Kit 0601610 4.2 Fr Broviac CV Catheter Repair Kit 0601620 6.6F Broviac CV Catheter Repair Kit 0601630 9.6F Hickman CV Catheter Repair Kit 0601680 Hickman / Leonard CV Catheter Repair Kit (all except 13.5F) 0601690 Hickman / Leonard CV Catheter Repair Kit (all except 13.5F) 0601700 9F Hickman CV Catheter Repair Kit 0601710 12F Hickman CV Catheter Repair Kit 0601730 Hickman / Leonard CV Catheter Repair Kit (all except 13.5F) 0601740 12.5F Hickman CV Catheter Repair Kit 0601750 10F Leonard CV Catheter Repair Kit 0601760 7F Hickman CV Catheter Repair Kit 0601790 10F Hickman CV Catheter Repair Kit. Reason: Due to the adhesive provided within the catheter repair kits maybe hardened/coagulated (unusable)..

Recalling firm: Bard Peripheral Vascular Inc
Classification: Class II
Status: Ongoing
Initiated: 2023-01-04
Firm location: Tempe, AZ, United States

510(k) clearances named in this recall

2 on FDA's record

K871998 — GROSHONG CV CATHETER REPAIR KITCatheter Technology Corp.·cleared 1987-06-24
K830406 — NON-STERILE CATHETER REPAIR KITSEvermed, Inc.·cleared 1983-03-01

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Catalog Number / Product Description 0601600 2.7F Broviac CV Catheter Repair Kit 0601610 4.2 Fr Broviac CV Catheter Repair Kit 0601620 6.6F Broviac CV Catheter Repair Kit 0601630 9.6F Hickman CV Catheter Repair Kit 0601680 Hickman / Leonard CV Catheter Repair Kit (all except 13.5F) 0601690 Hickman / Leonard CV Catheter Repair Kit (all except 13.5F) 0601700 9F Hickman CV Catheter Repair Kit 0601710 12F Hickman CV Catheter Repair Kit 0601730 Hickman / Leonard CV Catheter Repair Kit (all except 13.5F) 0601740 12.5F Hickman CV Catheter Repair Kit 0601750 10F Leonard CV Catheter Repair Kit 0601760 7F Hickman CV Catheter Repair Kit 0601790 10F Hickman CV Catheter Repair Kit

Reason for recall

Due to the adhesive provided within the catheter repair kits maybe hardened/coagulated (unusable).

Data sourced from openFDA. This site is unofficial and independent of the FDA.