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ADULT Radiotransparent Electrode, REF/Catalog Number 2001H… recallZ-0454-2015 · ConMed Corporation · initiated Nov 6, 2014

Class I Terminated All recalls posted in December 2014

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from ConMed Corporation or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

Philips Healthcare made changes to the design of the connection between multifunction electrodes and their HeartStart FR3 and HeartStart FRx AEDs. The failure to connect may result in a delay of therapy, which could result in patient death or serious injury.

FDA root cause category: Device Design

What the company is doing

ConMed sent an Urgent Device Correction letter dated November 16, 2014, to all affected consignees via UPS Next Day Air. The letter instructed consignees to notify all end users of the correction. For questions or additional information, consignees were instructed to contact ConMed at 1-727-399-5276 or by e-mail at [email protected]. International notices were sent via UPS Priority or equivalent by November 19, 2014.

Recall details

Recall number
Z-0454-2015
Recall class
Class I (most serious)
Status
Terminated
Initiated by the company
Nov 6, 2014
Posted by the FDA
Dec 4, 2014
Recalling firm
ConMed Corporation
Quantity
174,610 (168,090 US and 6,520 OUS) in total.
Product code
MKJ
FDA submissions
K014209
Distribution
Worldwide Distribution - USA (nationwide) Puerto Rico, and Internationally to Bosnia, Herzegovina, Brazil, Canada, Great Britain, Israel, Italy, Republic of Korea, Norway, Portugal, Saudi Arabia, and Spain.

Product description

ADULT Radiotransparent Electrode, REF/Catalog Number 2001H, Rx ONLY --- COMPARABLE TO PHILIPS MEDICAL HEARTSTART ELECTRODES PLUG STYLE CONNECTOR Intended for use during defibrillation, cardioversion, pacing, and ECG monitoring applications. This product is a single-use, disposable device.

Code information (models, lots, serial numbers)

All Lot Codes

Other devices under the same FDA submission

9 devices cleared under K014209 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Other products in the same recall event

The FDA groups related products into one recall event (event 69752).

Sources and updates

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