Recall Z-1365-2015 ยท KRA Catheter, Continuous Flush
Medtronic Inc. Cardiac Rhythm Disease Management
Covidien Trellis 6 and Trellis 8 Peripheral Infusion Systems, Sterile EO, Rx only. Models BVT608010V01, BVT608030V01, BVT612010V01, BVT612030V01, CVT808015, CVT808025, CVT812015, CVT812025, EVT808015, EVT808025, EVT812015, EVT812025, BVT808015, BVT808030, BVT812015, BVT812030, EUT808015, EUT808030, EUT812015, EUT812030. Product Usage: The Trellis 6 and Trellis 8 peripheral infusion system is inte
| Date | Apr 2, 2015 (initiated Mar 23, 2015) |
| Status | Terminated |
| Reason | Medtronic is conducting a voluntary recall of all former Covidien Trellis 6 and Trellis 8 Peripheral Infusion Systems due to potential for a sterility breach of the outer packaging or pouch material. A breach of the outer pouch may compromise the outside surface sterility of the inner pouch and does not directly affect the sterility of the device components within the inner pouch. |
| Root cause | Package design/selection |
| Action | Consignees were sent on 3/23/2015 a Medtronic "Urgent Medical Device Recall" letter dated March, 2015. The letter described the problem and the product involved in the recall. Consignees were advised to quarantine and return the product and to complete and return the Customer Confirmation Certificate to Medtronic. For questions contact your Medtronic Sales Representative or Customer Service a 1-800-716-6700. |
| Quantity | 8,269 ( 6,786 US, 1,483 OUS) |
| Distribution | Worldwide Distribution: US (nationwide) including all states in continental USA, except DE and including DC and PR; and countries: AUSTRIA, AUSTRALIA, NEW ZEALAND, BELGIUM, CZECH REPUBLIC, DENMARK, EGYPT, FINLAND, FRANCE, GEORGIA, GERMANY, IRELAND, ITALY, NETHERLANDS, POLAND, PORTUGAL, ROMANIA, RUSS |
| FDA record | Open on fda.gov |