Home / Recalls / Abbott Vascular / Z-2039-2017

Z-2039-2017 Class I Terminated

Recalled by Abbott Vascular — Temecula, CA

Recall Details

Product Type
Devices
Report Date
May 24, 2017
Initiation Date
March 22, 2017
Termination Date
February 7, 2018
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
449,661 units total (132,040 units in US)

Product Description

NC Tenku RX PTCA Balloon Catheter, Part No. 1012448-08T, 1012448-12T, 1012448-15T, 1012449-08T, 1012449-12T, 1012449-15T, 1012450-08T, 1012450-12T, 1012450-15T, 1012451-08T, 1012451-12T, 1012451-15T, 1012452-08T, 1012452-12T, 1012452-15T, 1012453-08T, 1012453-12T

Reason for Recall

Products from the identified lots may exhibit difficulty in removing the protective balloon sheath which can result in issues with inflating or deflating the balloon.

Distribution Pattern

US and Worldwide

Code Information

Lot Number 60202G1 60301G1 60502G1 60301G1 60401G1 61101G1 60202G1 60401G1 60601G1 60801G1 61101G1 60302G1 60401G1 60601G1 60801G1 60202G1 60401G1 60502G1 60601G1 60701G1 60902G1 61004G1 61101G1 60202G1 60301G1 60401G1 60502G1 60601G1 60701G1 60801G1 60902G1 61101G1 60401G1 60601G1 60801G1 60301G1 60701G1 60301G1 60502G1 60701G1 60301G1 60502G1 60701G1 60902G1 60301G1 60502G1 60701G1 61004G1 60301G1 60401G1 60601G1 60701G1 60805G1 61004G1 50204G1 50406G1 50202G1 50901G1 50204G1 60202G1 60502G1 60701G1 61101G1 60202G1 60506G1

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