Reported Apr 28, 2021 · Terminated
The AMS 700 Inflatable Penile Prosthesis is a closed fluid-filled system containing saline. The system is made out of…
Boston Scientific Corporation
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Boston Scientific Corporation · 100 Boston Scientific Way · Marlborough, MA · 01752-1234
Is this the product you have?
- 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 componentsa 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
720185-0172404156
- Lot codes and dates
- Lot
2614710026154112
- Lot
- Amount recalled
- 23 units
Where it was sold
Why it was recalled
An AMS 700 100 mL Spherical Reservoir with InhibiZone was incorrectly labeled as a 100 mL Conceal Reservoir with InhibiZone.
This product could cause temporary or reversible health problems — stop using it.
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