Z-0895-2022 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- April 13, 2022
- Initiation Date
- November 9, 2021
- Termination Date
- August 7, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 529 units
Product Description
Amplatzer Steerable Delivery Sheath
Reason for Recall
Instructions for use were updated.
Distribution Pattern
OUS distribution only
Code Information
Model ASDS-14F-075, Batch Numbers: 1) 7963817 2) 7976534 3) 7981029 4) 7990340 5) 8008111 6) 8010056 7) 8025120 8) 8102214 9) 8106240 10) 8234848 11) 8274323 12) 8277741