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U.S. Department of Health and Human Services

Class 2 Device Recall Guidewire 70cm x 1mm (0.038)

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 Class 2 Device Recall Guidewire 70cm x 1mm (0.038)see related information
Date Initiated by FirmJuly 10, 2024
Date PostedSeptember 06, 2024
Recall Status1 Open3, Classified
Recall NumberZ-3062-2024
Recall Event ID 95039
510(K)NumberK770977 
Product Classification Wire, guide, catheter - Product Code DQX
ProductGuidewire 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.
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
FEI Number 2020394
Recalling Firm/
Manufacturer		 Bard Peripheral Vascular Inc
1625 W 3rd St Bldg 1
850 W. Rio Salado Prkwy.
Tempe AZ 85281-2438
For Additional Information Contact
480-303-2602
Manufacturer 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.
FDA Determined
Cause 2		Under Investigation by firm
ActionOn 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: productcomplaints@bd.com. For recall related questions email BDRC14@BD.COM
Quantity in Commerce625 units
DistributionWorldwide - U.S. Nationwide distribution in the states of OH, TX, and WV. The countries of Belgium, Canada, France, Italy, and United Kingdom.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = DQX
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