—#50638

Product

PADPRO ADULT Radiotranslucent Pad w/Zoll connector. Defibrillation/Pacing/Cardioversion/Monitoring Electrodes, REF/Catalog # 2516Z. RX ONLY. Made in USA for: CONMED CORPORATION Utica, New York, 13502.

FDA product code: MLN — Electrode, Electrocardiograph, Multi-Function
Device class: Class 2
Medical specialty: Cardiovascular
510(k) numbers: K020203
Affected lot / code info: Lots Y040605-1, Y040605-2, Y052605-4, Y120805-2, Y111605-3, Y092805-6, Y010506-10, Y010506-9.

Why it was recalled

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.

Root cause (FDA determination)

Other

Action the firm took

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.

Recalling firm

Firm: Conmed Corporation
Address: 525 French Road, Utica, New York 13502-5945

Distribution

Distribution pattern: Worldwide, including USA, Canada, Romania, Chile, and Belgium

Timeline

Recall initiated: 2007-03-08
Posted by FDA: 2007-04-24
Terminated: 2012-07-16
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #50638. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.