FDAClass IIOctober 15, 2014

ZOLL Pro-padz Sterile Adult Multi-Function Electrodes recall: Sterility Concern

ZOLL Pro-padz Sterile Adult Multi-Function Electrodes with 10-ft (3 m) leadwires, 1 single Part number: 8900-4055-40 Product Usage: These MFE…

Why was ZOLL Pro-padz Sterile Adult Multi-Function Electrodes recalled?

Product sterility is not assured

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot Numbers: 1614, 1914, 2114

Product
ZOLL Pro-padz Sterile Adult Multi-Function Electrodes with 10-ft (3 m) leadwires, 1 single Part number: 8900-4055-40 Product Usage: These MFE…
Recalling firm
Bio-Detek, Inc.
Quantity
41 singles
Distribution
Worldwide Distribution - US Nationwide and the countries of: Australia, Canada, Belgium, France, and Germany.
Recall date
October 15, 2014
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls