Recall Z-1017-2015 ยท KRA Catheter, Continuous Flush
Covidien
Covidien Trellis-6 Peripheral Infusion System. Models BVT608010V01, BVT608030V01, BVT612010V01, and BVT612030V01. Sterile EO. Product Usage: Intended for controlled and selective infusion of physician-specified fluids, including thrombolytics, into the peripheral vasculature.
| Date | Feb 3, 2015 (initiated Dec 10, 2014) |
| Status | Terminated |
| Reason | A manufacturing error resulted in the risk of incorrect proximal and distal balloon inflation port identification on the units. Units have been identified to have the distal balloon inflation port incorrectly labeled as proximal, and, the proximal balloon port incorrectly labeled as distal. |
| Root cause | Mixed-up of materials/components |
| Action | Consignees were sent an Urgent Product Recall letter dated 12/15/2014. The letter described the issue, identified the affected product, and the required actions. Affected product was to be returned directly to customers' Covidien Sales Rep; or customers were to contact Covidien Service at 1-800-716-6700 to arrange for product return. Questions can be directed to the Covidien Sales Rep or to Covidien Service at 1-800-716-6700. Customers were to complete and return the Verification Form along with the unused product as soon as possible. |
| Quantity | 216 devices (207 US, 9 OUS) |
| Distribution | Worldwide Distribution - US Nationwide and the countries Australia, Canada, Finland, France, Germany, Ireland, Italy, Spain, Sweden, Switzerland, Turkey, and United Kingdom. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K071664 | TRELLIS-6 PERIPHERAL INFUSION SYSTEM Bacchus Vascular, Inc., Jul 13, 2007 |