Recall Z-1365-2015
Medtronic Inc. Cardiac Rhythm Disease Management · initiated March 23, 2015
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
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.
Codes / lots: Model Lot Number" BVT608010 551902 BVT608010 551975 BVT608010 552014 BVT608030 551796 BVT608030 551873 BVT608030 551893 BVT608030 551923 BVT608030 552011 BVT608030 552097 BVT612010 551789 BVT612010 551837 BVT612010 551894 BVT612010 551974 BVT612010 551976 BVT612010 552030 BVT612010 552226 BVT612030 551808 BVT612030 551903 BVT612030 551904 BVT612030 551924 BVT612030 551980 BVT612030 552007 BVT612030 552017 BVT612030 552034 BVT612030 552071 BVT612030 552081 BVT612030 552229 BVT808015 551466 BVT808015 551797 BVT808015 551804 BVT808015 551895 BVT808015 551942 BVT808015 551950 BVT808015 551984 BVT808015 552020 BVT808015 552027 BVT808015 552067 BVT808015 552113 BVT808030 551436 BVT808030 551437 BVT808030 551464 BVT808030 551798 BVT808030 551803 BVT808030 551812 BVT808030 551841 BVT808030 551863 BVT808030 551897 BVT808030 551899 BVT808030 551922 BVT808030 551943 BVT808030 551947 BVT808030 551977 BVT808030 551981 BVT808030 551986 BVT808030 551999 BVT808030 552010 BVT808030 552012 BVT808030 552028 BVT808030 552084 BVT808030 552100 BVT808030 552119 BVT808030 552120 BVT808030 552146 BVT808030 552168 BVT808030 552174 BVT808030 552180 BVT812015 551471 BVT812015 551805 BVT812015 551816…
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.
FDA-determined cause: Package design/selection
Action taken
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.
Details
- Recall number
- Z-1365-2015
- Initiated
- March 23, 2015
- Posted by FDA
- April 2, 2015
- Terminated
- August 11, 2016
- Product code
- KRA – Catheter, Continuous Flush
- 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, RUSSIA, SPAIN, SWEDEN SWITZERLAND, TURKEY, UNITED KINGDOM, CHILE, EL SALVADOR, PANAMA, and CANADA.
- Recalling firm
- Medtronic Inc. Cardiac Rhythm Disease Management, Saint Paul, MN