Z-2674-2017 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- July 12, 2017
- Initiation Date
- June 1, 2017
- Termination Date
- June 26, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 32 units
Product Description
Boston Scientific Extractor Pro RX-S Retrieval Balloon Catheter 12-15mm Below UPN: M00547340
Reason for Recall
Label on the affected devices incorrectly identifies the injection location as "above" the balloon when it should be below the balloon and "below" the balloon when it should be above the balloon
Distribution Pattern
MI, MO Foreign: Austria France Great Britain Italy Spain Sweden
Code Information
Lot Number: 19343209 Exp: 6/3 0/2018