FDA Device recall Z-2442-2019
AMS 800 Artificial Urinary Sphincter AMS 800 Belt Cuff, 4.5 cm Part Number: 72400161
- FDA Device
- Class II
- terminated
- Published 2019-09-11
On 2019-09-11 the FDA classified a Class II recall of AMS 800 Artificial Urinary Sphincter AMS 800 Belt Cuff, 4.5 cm Part Number: 72400161 by Boston Scientific, citing mislabled: AMS 800 occlusive cuff labeled as 4.5 cm was a length of 4.0 cm and therefore.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2442-2019 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2019-07-19 |
| Published | 2019-09-11 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Boston Scientific |
| Distribution | MN |
Product
AMS 800 Artificial Urinary Sphincter AMS 800 Belt Cuff, 4.5 cm Part Number: 72400161
Reason
Mislabled: AMS 800 occlusive cuff labeled as 4.5 cm was a length of 4.0 cm and therefore..
Identifiers
| code_info | Lot Number: 23973023 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2442-2019%22
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