Recall archive / FDA device enforcement
Guidewire 70cm x 1mm (0.038 ) REF 5583705 These accessories are intended for use with Bard 14.5 Fr. Long-Term Dual Lu... — FDA record Z-3062-2024
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Jul 10, 2024. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- 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.
- Classification
- Class II
- Recalling firm
- Bard Peripheral Vascular Inc
- Quantity
- 625 units
- Agency-reported status
- Ongoing
- Source record identifier
- Z-3062-2024
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | 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 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
Worldwide - U.S. Nationwide distribution in the states of OH, TX, and WV. The countries of Belgium, Canada, France, Italy, and United Kingdom.
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
- Alaska
- Alabama
- Arkansas
- Arizona
- California
- Colorado
- Connecticut
- Delaware
- Florida
- Georgia
- Hawaii
- Iowa
- Idaho
- Illinois
- Indiana
- Kansas
- Kentucky
- Louisiana
- Massachusetts
- Maryland
- Maine
- Michigan
- Minnesota
- Missouri
- Mississippi
- Montana
- North Carolina
- North Dakota
- Nebraska
- New Hampshire
- New Jersey
- New Mexico
- Nevada
- New York
- Ohio
- Oklahoma
- Oregon
- Pennsylvania
- Rhode Island
- South Carolina
- South Dakota
- Tennessee
- Texas
- Utah
- Virginia
- Vermont
- Washington
- Wisconsin
- West Virginia
- Wyoming
Dates in the source
- Report date
- Sep 18, 2024
- Recall initiation date
- Jul 10, 2024
- Center classification date
- Sep 6, 2024
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.