FDA Recall Terminated

Welch Allyn AED 10 Defibrillator; a battery powered automated external defibrillator; Manufacturer: MRL, Inc., A Welch Allyn Company, 100 Asbury Drive, Buffalo Grove, Illinois 60089; Model AED10, part numbers 970300 (defibrillator) and 970302 (defibrillator with soft shell carrying case)

Recall: Z-0918-04 · Initiated April 26, 2004

Recall

Recall Number: Z-0918-04
Event Number: 28880
Firm: MRL, Inc., A Welch Allyn Company
FEI Number: 1418729
Product Code: MKJ--
Status: Terminated
Root Cause: Other
Initiated: April 26, 2004
Posted: July 20, 2004
Terminated: November 15, 2004
Address: 1000 Asbury Dr, Ste 17, Buffalo Grove, IL, 60089-4551

Description

Reason

A faulty component has been identified which could result in an intermittent shock button (button #3) failure on the AED10 defibrillator.

Action

Urgent Medical Device Recall letters dated 4/26/04 were sent to the end users via certified mail on 4/26/04. The letters informed the users of the intemittent shock (fire or 3) button failure on the AED 10. The letters included a list of the affected serial numbers, and requested the users to call Welch Allyn MRL Technical Support as soon as possible at 1-800-462-0777 for a replacement AED 10 and to answer any questions. A replacement AED 10 will be sent to the end users within 10 days, and the users were requested to return their AED 10 in the same shipping box accompanying the replacement unit. A follow-up letter will accompany the replacement unit with instructions on how to verify the affected units, packing instructions for the return of the affected units to Welch Allyn MRL, and a correction response form to be completed and enclosed with the returned unit.

Distribution

Nationwide, and internationally to the United Kingdom, Ireland, Singapore, France and South Africa.

Quantity

460 units