FDA recall Z-0895-2022
Abbott · Class II · device
Product
Amplatzer Steerable Delivery Sheath
Reason for recall
Instructions for use were updated.
Distribution
OUS distribution only
Key facts
- Status
- Terminated
- Initiation date
- 2021-11-09
- Report date
- 2022-04-13
- Termination date
- 2024-08-07
- Voluntary/Mandated
- Voluntary: Firm initiated
- Location
- Plymouth, MN, United States
Primary source
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0895-2022