Recall Z-3062-2024 ยท DQX Wire, Guide, Catheter
Bard Peripheral Vascular Inc
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.
| Date | Sep 6, 2024 (initiated Jul 10, 2024) |
| Status | Open, Classified |
| 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. |
| 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 facilit |
| Quantity | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K770977 | CARDIOVASCULAR SPRING GUIDES Lake Region Mfg., Inc., Jun 14, 1977 |