Z-1017-2015 Class I Terminated
FDA device recall Z-1017-2015 was initiated by Covidien on Dec 10, 2014 and is designated Class I. Reason for recall: 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… The recall status is terminated (terminated Mar 31, 2016). Affected quantity: 216 devices (207 US, 9 OUS).
Recall Details
- Product Type
- Devices
- Report Date
- Feb 11, 2015
- Initiation Date
- Dec 10, 2014
- Termination Date
- Mar 31, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 216 devices (207 US, 9 OUS)
Product Description
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.
Reason for Recall
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.
Distribution Pattern
Worldwide Distribution - US Nationwide and the countries Australia, Canada, Finland, France, Germany, Ireland, Italy, Spain, Sweden, Switzerland, Turkey, and United Kingdom.
Code Information
Model BVT608010, Lot numbers: 9853174, 9864497, 9890772, 9890931, 9925676, 9932672, 9937308, 9937315, 9940474, 9940614, 9976340, 9978233, A001589, A001740. Model BVT608030, Lot Numbers: 9853331, 9887597, 9887695, 9887757, 9932042. Model BVT612010, Lot numbers: 9854121, 9868214, 9868311, 9875472, 9875632, 9876174, 9883295, 9884788, 9884951, 9886196, 9886312, 9932096, 9968511, 9974109, 9974126, 9976472, 9977091, 9978862, A002299, A002423. Model BVT312030, Lot numbers: 9854124, 9892081, 9941213, 9971096, 9971139, 9976506, 9977140, 9978964, 9979548, A003021, A003121, A003651, A007900, A008492, A008603, A008687.
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1017-2015
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026