PADPRO ADULT Radiotranslucent Pad w/Zoll connector. Defibrillation/Pacing/Cardioversion/Monitoring Electrodes, REF/Catal

FDA device recall Z-0756-2007 · posted 2007-04-24 · Terminated

Recall details

Recalling firm

Conmed Corporation

Reason for recall

Firm was notified of three incidents over the past 15 months in which customers opened the pouch & found an incorrect connector. This error makes the product unusable. The Zoll and Medtronic connectors are not interchangeable and are unique to their specific device.

Action taken

On 3/08/07, "URGENT DEVICE RECALL" letters (dated 3/05/07) will be sent via UPS to the US distributors and direct user accounts. The letters inform them of the problem and of the recall. The letters instruct them to immediately discontinue using the affected lots, inspect their stocks, and to return them as soon as possible. The letters instruct the consignees to notify their customers of the recall of the devices to the user level if they have been distributed, and request the return of the products. Additionally, when requested, ConMed will notify distributor's customers (sub-accounts) by the same means. Returned devices will be automatically replaced by ConMed Corporation. A separate letter is being sent to the foreign accounts today instructing them to return the devices back to ConMed Corporation for final disposition. The letters also instruct the consignees to complete the accompanying reply form and fax it to Nancy Crisino at (315) 624-3089. ConMed has contracted Stericycle in Indianapolis, IN, to handle the recall and returns from the domestic accounts.

Root cause

Other

Status

Terminated

Product code

MLN

Quantity affected

9712 pairs

Distribution

Worldwide, including USA, Canada, Romania, Chile, and Belgium

Date initiated

2007-03-08

Date posted

2007-04-24

Date terminated

2012-07-16

Location

Utica, NY

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