AMS 800 Artificial Urinary Sphincter AMS 800 Belt Cuff, 4.5 cm Part Number: 72400161
Reported: September 11, 2019 Initiated: July 19, 2019 #Z-2442-2019
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..
Details
- Recalling Firm
- Boston Scientific Corporation
- Units Affected
- 1 unit
- Distribution
- MN
- Location
- Marlborough, MA
Frequently Asked Questions
What product was recalled? ▼
AMS 800 Artificial Urinary Sphincter AMS 800 Belt Cuff, 4.5 cm Part Number: 72400161. Recalled by Boston Scientific Corporation. Units affected: 1 unit.
Why was this product recalled? ▼
Mislabled: AMS 800 occlusive cuff labeled as 4.5 cm was a length of 4.0 cm and therefore..
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on September 11, 2019. Severity: Moderate. Recall number: Z-2442-2019.
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