AMS 700 CX MS Pump IZ, Preconnect Penoscrotal, 18 cm, Sterile EO, REF 72404232, Lot 551668001. Expiration Date 2010-Jun-

FDA device recall Z-2461-2008 · posted 2008-09-20 · Terminated

Recall details

Recalling firm

American Medical Systems

Reason for recall

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.

Action taken

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 complaint was assigned to document the event.

Root cause

Employee error

Status

Terminated

Product code

JCW

Quantity affected

5 units

Distribution

LA

Date initiated

2008-07-17

Date posted

2008-09-20

Date terminated

2012-05-01

Location

Minnetonka, MN