AMS 800 Urinary Control System Control Pump, REF 72400098, (720172-01 Japan only ), Sterilization Method Steam, American

FDA device recall Z-2669-2011 · posted 2011-06-27 · Terminated

Recall details

Recalling firm

American Medical Systems, Inc.

Reason for recall

American Medical Systems is recalling all unexpired AMS 800 and AMS Acticon Neosphincter Control Pumps. Based upon a review of our product test procedures, we are unable to confirm that all Control Pumps have met our requirements. Test errors could potentially result in a failure to identify a malfunction in the Control Pump activation mechanism. This malfunction may lead to inadvertent activa

Action taken

American Medical System sent an "URGENT MEDICAL DEVICE RECALL letter dated May 9, 2011, to all affected customers. The letter identified the product, the problem and the action needed to be taken by the customer Customers were instructed to return any existing stock . Please contact American Medical System at 1 (800) 328-3881 to obtain a Return Authorization number. Customer Service will also provide a FedEx shipping number for your use to return affected product. For further questions please contact American Medical Systems at 1- (800)328-3881.

Root cause

Nonconforming Material/Component

Status

Terminated

Product code

EZY

Quantity affected

15,466

Distribution

Worldwide Distribution--USA (nationwide) including Washington D.C. and Puerto Rico and the countries FRANCE, GERMANY, CANADA, ISRAEL, SOUTH AFRICA, LEBANON, AUSTRIA, ARGENTINA, SAUDI ARABIA, SPAIN, BE

Date initiated

2011-05-09

Date posted

2011-06-27

Date terminated

2012-07-06

Location

Minnetonka, MN