Z-2442-2019 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- September 11, 2019
- Initiation Date
- July 19, 2019
- Termination Date
- April 23, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1 unit
Product Description
AMS 800 Artificial Urinary Sphincter AMS 800 Belt Cuff, 4.5 cm Part Number: 72400161
Reason for Recall
Mislabled: AMS 800 occlusive cuff labeled as 4.5 cm was a length of 4.0 cm and therefore..
Distribution Pattern
MN
Code Information
Lot Number: 23973023