FDA Device recall Z-3062-2024
Guidewire 70cm x 1mm (0.038 ) REF 5583705 These accessories are intended for use with Bard 14.5 Fr. Long-Term Dual Lumen Hemodialysis Cathe…
- FDA Device
- Class II
- ongoing
- Published 2024-09-18
On 2024-09-18 the FDA classified a Class II recall of Guidewire 70cm x 1mm (0.038 ) REF 5583705 These accessories are intended for use with Bard 14.5 Fr. Long-Term Dual Lumen Hemodialysis Cathe… by Bard Peripheral Vascular, citing 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 dist….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-3062-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-07-10 |
| Published | 2024-09-18 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Bard Peripheral Vascular |
| Distribution | US |
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.
Identifiers
| code_info | Catalog Number: 5583705 Lot Number / UDI codes: REGZ2564 (01)00801741085451(17)271130(10)REGZ2564 REFV0870 (01)00801741…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 |
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Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3062-2024%22
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