Z-2038-2017 Class I Terminated
FDA device recall Z-2038-2017 was initiated by Abbott Vascular on March 22, 2017 and is designated Class I. 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. The recall status is terminated (terminated February 7, 2018). Affected quantity: 449,661 units total (132,040 units in US).
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 Traveler RX Coronary Dilatation Catheter, Part No. 1013152-12, 1013152-15, 1013152-20, 1013153-08, 1013153-12, 1013153-15, 1013153-20, 1013154-08, 1013154-12, 1013154-15, 1013154-20, 1013155-08, 1013155-12 1013155-15, 1013155-20, 1013156-12, 1013156-15, 1013157-08, 1013157-12, 1013157-15
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 61209G1 61209G2 61102G1 61102G1 61012G1 61209G1 61101G1 60415G1 61209G1 61102G1 61101G1 61101G1 61102G1 60415G1 61102G1 61101G1 60415G1 61209G1 61102G1 50415G1 50919G1 51110G1 61209G1 50919G1 51210G1 61101G1 61102G1 60415G1 61102G1 60415G1 61209G1