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Terminated

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 intended for controlled and selective infusion of physician-specified fluids, including thrombolytics, into the peripheral vasculature.

FDA Recall Z-1365-2015 · Posted 2015-04-02

Recalling FirmMedtronic Inc. Cardiac Rhythm Disease Management
Recall StatusTerminated
Product CodeKRA
Date Initiated2015-03-23
Date Terminated2016-08-11
Product Quantity8,269 ( 6,786 US, 1,483 OUS)

Reason for Recall

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.

Firm 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.

Root Cause

Package design/selection

Distribution Pattern

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, RUSSIA, SPAIN, SWEDEN SWITZERLAND, TURKEY, UNITED KINGDOM, CHILE, EL SALVADOR, PANAMA, and CANADA.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K130904TRELLIS-8 PERIPHERAL INFUSION SYSTEMCovidien · 2013-10-25K071664TRELLIS-6 PERIPHERAL INFUSION SYSTEMBacchus Vascular, Inc. · 2007-07-13

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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