Z-3062-2024Class II

Guidewire 70cm x 1mm (0.038 ) REF 5583705 These accessories are intended for use with Bard 14.5 Fr. Long-Term...

Name: Z-3062-2024 Guidewire 70cm x 1mm (0.038 ) REF 5583705 These accessories are intended for use with Bard 14.5 Fr. Long-Term...
Creator: Bard Peripheral Vascular Inc
Published: 2024-07-10
License: https://open.fda.gov/license/

Bard Peripheral Vascular Inc / initiated 2024-07-10 / Open, Classified / root cause: manufacturing process

FDA source

Bard Peripheral Vascular Inc began a 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 Catheters. Please refer... on 2024-07-10. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-3062-2024
Classification: Class II
Status: Open, Classified
Initiated: 2024-07-10
Posted: 2024-09-06
Recalling firm: Bard Peripheral Vascular Inc
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.
Product code: DQX Wire, Guide, Catheter
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.
Root cause tag: manufacturing process
FDA root cause: Under Investigation by firm
Action: On 08/01/2024, the firm sent an "URGENT: Medical Device Product Removal" letter via US mail and email to customers informing them that the firm has received multiple reports that guidewire may have been mis-assembled within the hoop such that the proximal (stiff) end of the guidewire is located at the distal end of the hoop. Customers are instructed to: 1. Discontinue use of product listed in the letter, and immediately dispose of all affected product remaining in their possession in accordance with their local facility s process. 2. Share this notification with all users within their facility network of the product to ensure they are also aware of this field action. If the affected products have been distributed further, ensure that these entities are contacted and informed of the recall. 3. Complete and return the attached Customer Response Form and return it to the BD contact noted on the form whether or not they have any of the product so that BD may acknowledge your receipt of this notification and subsequently process any required credits. 4. Indicate on the response form the quantity of product identified at their facility and confirm that this product inventory was disposed of. 5. If products were purchased from a distributor, contact the distributor for further instructions and credit resolution. For questions/assistance contact: BD North American Regional Complaint Center for Product Complaints/Technical Questions at: Phone: 1-844-8BD-LIFE (1-844-823-5433) Say Complaints when prompted Mon Fri 8:00am and 5:00pm CT, or Email: [email protected]. For recall related questions email [email protected]
Quantity in commerce: 625 units
Distribution: Worldwide - U.S. Nationwide distribution in the states of OH, TX, and WV. The countries of Belgium, Canada, France, Italy, and United Kingdom.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-3062-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-3062-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-09-18	2024-09-06

Product code DQX

K770977Class IICardiovascular Spring GuidesLake Region Mfg., Inc. / cleared 1977-06-14

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)