Z-1433-2021 Class II Terminated
FDA device recall Z-1433-2021 was initiated by Boston Scientific Corporation on March 26, 2021 and is designated Class II. Reason for recall: An AMS 700 100 mL Spherical Reservoir with InhibiZone was incorrectly labeled as a 100 mL Conceal Reservoir with InhibiZone. The recall status is terminated (terminated March 4, 2024). Affected quantity: 23 units.
Recall Details
- Product Type
- Devices
- Report Date
- April 28, 2021
- Initiation Date
- March 26, 2021
- Termination Date
- March 4, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 23 units
Product Description
The AMS 700 Inflatable Penile Prosthesis is a closed fluid-filled system containing saline. The system is made out of silicone and consists of 4 main components: a pump, two cylinders, a fluid reservoir and kink-resistant tubing that is used to connect the pump to the cylinders and fluid reservoir. By pumping the fluid within the system from the reservoir via the pump and into the cylinders, the product creates an erection in men who have chronic, organic, erectile dysfunction. Part Number: 720185-01, 72404156
Reason for Recall
An AMS 700 100 mL Spherical Reservoir with InhibiZone was incorrectly labeled as a 100 mL Conceal Reservoir with InhibiZone.
Distribution Pattern
Worldwide distribution. US distribution to AR, AZ, CO, FL, GA, IA, MI, MO, NE, OR, PA, TN, TX, and UT. Belgium, France, Portugal
Code Information
Lot: 26147100, 26154112