Recall Z-3062-2024— Bard Peripheral Vascular Inc

Name: FDA recall Z-3062-2024
Creator: U.S. Food and Drug Administration
Published: 2024-07-10

Class II · Ongoing

Class II FDA medical device recall by Bard Peripheral Vascular Inc, initiated 2024-07-10. It names one FDA 510(k) clearance: K770977. Product: Guidewire 70cm x 1mm (0.038 ) REF 5583705 These accessories are intended for use with Bard 14.5 Fr. Long-Term Dual Lumen Hemodialysis Catheters. Please refer to the applicable catheter Instructions for Use for directions on the use of these accessories.. Reason: Due to guidewires being manufactured incorrectly with the guidewires being mis-assembled within the hoop such that the proximal (stiff) end of the guidewire is located at the distal end of the hoop. Injury could occur if the user attempts to insert the proximal end into the patient..

Recalling firm: Bard Peripheral Vascular Inc
Classification: Class II
Status: Ongoing
Initiated: 2024-07-10
Firm location: Tempe, AZ, United States

510(k) clearances named in this recall

1 on FDA's record

K770977 — CARDIOVASCULAR SPRING GUIDESLake Region Mfg., Inc.·cleared 1977-06-14

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

Guidewire 70cm x 1mm (0.038 ) REF 5583705 These accessories are intended for use with Bard 14.5 Fr. Long-Term Dual Lumen Hemodialysis Catheters. Please refer to the applicable catheter Instructions for Use for directions on the use of these accessories.

Reason for recall

Due to guidewires being manufactured incorrectly with the guidewires being mis-assembled within the hoop such that the proximal (stiff) end of the guidewire is located at the distal end of the hoop. Injury could occur if the user attempts to insert the proximal end into the patient.

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