PadPro(R) Adult Radiotransparent Multifunction Electrodes, REF/Catalog No. 2001M-C. The PadPro(R) Adult Radiotransparent

FDA device recall Z-1317-2013 · posted 2013-05-13 · Terminated

Recall details

Recalling firm

ConMed Corporation

Reason for recall

ConMed was notified by the contract manufacturer that their wire/connector supplier reported damage to the connector tooling which could pinch or compress the lead wire filaments and potentially render the device incapable of delivering the appropriate energy or shock to the patient and/or could cause potential injury to user or patient.

Action taken

ConMed sent a URGENT: Field Safety Notice letter dated May 3, 2013, 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 please review your inventory for any of the devices listed on Attachment I. Business Reply Forms were sent to the domestic and foreign consignees on May 3, 2013. The domestic notices were mailed by USP Priority Mail pouches. The recall is being conducted to the end user level. We ask that you contact all of those organizations within your facility and any other facilities that you may have supplied or given these affected products to. It is imperative that all end users of these devices receive this notice and respond immediately. If you have questions, please call 1 315-624-3237 or fax to +1 315-624-3225.

Root cause

Component design/selection

Status

Terminated

Product code

MKJ

Quantity affected

Domestic: 49,010; Foreign: 600

Distribution

Worldwide distribution: USA (nationwide) and the country of: Saudi Arabia.

Date initiated

2013-05-03

Date posted

2013-05-13

Date terminated

2015-08-25

Location

Utica, NY

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