Boston Scientific Corporation Recall 87671
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
Boston Scientific Corporation Recall 87671 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-1433-2021 |
| Event ID | 87671 |
| Event 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 |
| Product Type | Devices |
| Distribution | Worldwide distribution. US distribution to AR, AZ, CO, FL, GA, IA, MI, MO, NE, OR, PA, TN, TX, and UT. Belgium, France, Portugal |
| Quantity | 23 units |
| Recall Reason | An AMS 700 100 mL Spherical Reservoir with InhibiZone was incorrectly labeled as a 100 mL Conceal Reservoir with InhibiZone. |
| Device Classification | 20210428 |
| Device Code Info | Lot: 26147100, 26154112 |
| Center Classification Date | 20210416 |
| Recall Initiation Date | 20210326 |
| Recalling Firm | Boston Scientific Corporation |
| Initial Notification | |
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