Bard Peripheral Vascular Inc: Medical Device Recall in 2024 - (Recall #: Z-3062-2024)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2024.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: July 10, 2024

Date Posted: September 18, 2024

Recall Number: Z-3062-2024

Event ID: 95039

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.

Status: Ongoing

Product Quantity: 625 units

Code Information:

Catalog Number: 5583705 Lot Number / UDI codes: REGZ2564 (01)00801741085451(17)271130(10)REGZ2564 REFV0870 (01)00801741085451(17)260731(10)REFV0870 REFU4050 (01)00801741085451(17)260630(10)REFU4050 REFT3309 (01)00801741085451(17)260531(10)REFT3309 REEX1002 (01)00801741085451(17)250930(10)REEX1002 REEW2740 (01)00801741085451(17)250831(10)REEW2740 REEV0897 (01)00801741085451(17)250731(10)REEV0897 REDY2576 (01)00801741085451(17)241031(10)REDY2576 REEU1584 (01)00801741085451(17)250630(10)REEU1584 REER0990 (01)00801741085451(17)250331(10)REER0990 REEQ0825 (01)00801741085451(17)250228(10)REEQ0825

Distribution Pattern:

Worldwide - U.S. Nationwide distribution in the states of OH, TX, and WV. The countries of Belgium, Canada, France, Italy, and United Kingdom.

Voluntary or Mandated:

Voluntary: Firm initiated