Recalls / —
—#179240
Product
AMS 700 100 mL, Spherical Reservoir with InhibiZone, Part No. 72404156 - Product Usage: intended for use in the treatment of chronic, organic, male erectile dysfunction (impotence).
- FDA product code
- JCW — Prosthesis, Penis, Inflatable
- Device class
- Class 3
- Medical specialty
- Gastroenterology, Urology
- Affected lot / code info
- Lot 24464037
Why it was recalled
A labeling discrepancy incorrectly labeled AMS 700 100mL Conceal Low Profile Reservoir with InhibiZone as 100mL Spherical Reservoir with InhibiZone.
Root cause (FDA determination)
Mixed-up of materials/components
Action the firm took
On December 17, 2019, the firm sent an Urgent Medical Device Product Advisory letter to affected customers. Customers were informed of the labeling mix-up and instructed to add the advisory notice to the patient record. Customers were also asked to complete and returned an enclosed acknowledgement form. Customers with questions should contact their local Sales Representative.
Recalling firm
- Firm
- Boston Scientific Corporation
- Address
- 300 Boston Scientific Way, Marlborough, Massachusetts 01752-1291
Distribution
- Distribution pattern
- US Nationwide distribution including in the states of CA, MD, NC, NV, and TX.
Timeline
- Recall initiated
- 2019-12-17
- Posted by FDA
- 2020-01-28
- Terminated
- 2020-06-04
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #179240. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.