Recall Z-2461-2008 ยท JCW Prosthesis, Penis, Inflatable
American Medical Systems
AMS 700 CX MS Pump IZ, Preconnect Penoscrotal, 18 cm, Sterile EO, REF 72404232, Lot 551668001. Expiration Date 2010-Jun-20, Manufacture Date 2008 Jun 20.
| Date | Sep 20, 2008 (initiated Jul 17, 2008) |
| Status | Terminated |
| Reason | The carton labeling does not match the product packaged inside. The package indicated that the device is an 18cm Preconnected MS pump while it is actually an 18cm Ultrex Preconnected MS Pump. |
| Root cause | Employee error |
| Action | On July 17, 2008, the physician who implanted the device received a phone call from AMS to discuss the event and be sure he understands what went wrong (Ultrex cylinders implanted instead of CX) and any new risks introduced to his patient so he can properly assess any impact it may have. A follow up letter " AMS Important Product Recall" dated July 21, 2008 was also sent to document the event and the call. The letter requested to return of the "Recall Acknowledgement Form". The second physician (tried not used) has already returned the device and will not receive further communication. A c |
| Quantity | 5 units |
| Distribution | LA |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.