Vascular Solutions Twin-Pass RX Dual Access Catheter, model 5210. Sterilized with Ethylene Oxide. The Twin-Pass dual acc
FDA device recall Z-0054-2017 · posted 2016-10-20 · Terminated
Recall details
- Recalling firm
- Vascular Solutions, Inc.
- Reason for recall
- Vascular Solutions is recalling Twin-Pass dual access catheters because there is a potential for excess manufacturing material to remain at the tip of the catheter or within the distal portion of the rapid exchange lumen.
- Action taken
- Vascular Solutions sent an Urgent Medical Device Recall letter via first class mail beginning 9/16/2016. The letter identified affected product, stated the issue, and instructed that product should not be used and to be returned to Vascular Solutions. A response form was requested to be returned. Questions can be directed to Customer service by e-mail at customerservice@vasc.com.
- Root cause
- Process control
- Status
- Terminated
- Product code
- DQY
- Quantity affected
- 11,670 units total
- Distribution
- Worldwide Distribution: US (nationwide) including Puerto Rico and outside the US to include: Australia, Austria, Belgium, Brazil, Canada, Cyprus, Czech Republic, Egypt, Finland, France, Germany, Greec
- Date initiated
- 2016-09-16
- Date posted
- 2016-10-20
- Date terminated
- 2018-05-04
- Location
- Maple Grove, MN
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| VASCULAR SOLUTIONS TWIN-PASS DUAL ACCESS CATHETER AND SKYWAY SUPPORT CATHETER (K060327) | Vascular Solutions, Inc. | 2006-04-12 |