FDAFDA · Food and drugs·Recall number 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 Catheters. Please refer to the applicable catheter Instructions for Use for directions on the use of these accessories.
Published September 18, 2024 · Recall initiated: July 10, 2024
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Bard Peripheral Vascular Inc
- Distributor
- Worldwide - U.S. Nationwide distribution in the states of OH, TX, and WV. The countries of Belgium, Canada, France, Italy, and United Kingdom.
- Lot
- 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
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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