FDAClass IINovember 7, 2018

Li-ion Battery Housing for AR-400 DrillSaw Sports 400 recall

Li-ion Battery Housing for AR-400 DrillSaw Sports 400 System Product Usage: The battery housing is used to house the battery that powers the AR-400…

Why was Li-ion Battery Housing for AR-400 DrillSaw Sports 400 recalled?

The Li-ion Battery Housing for the AR-400 DrillSaw Sports 400 System may not provide a complete seal around the battery, allowing for potential fluid ingress.

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA 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?

UDI Number 0888867223349; Material Number AR-400UBH; Batch Numbers: GB4091590, GB4103994, GB4211089, GB4241346, GB4260648, GB4279490, GB4320568, GB4426191, GB3854432, GB3854434, GB3854435

Product
Li-ion Battery Housing for AR-400 DrillSaw Sports 400 System Product Usage: The battery housing is used to house the battery that powers the AR-400…
Recalling firm
Arthrex, Inc.
Quantity
335 devices
Distribution
Worldwide - Nationwide Distribution in the states of AL, CA, CO, FL, ID, IL, MA, MD, MI, MO, NC, NE, NY, PA, SC, TN, TX, UT, WI. and the countries of Austria, Canada, China, Croatia, Czech Republic, Denmark, Finland, France, Germany, Great Britain, Greece, Italy, Kuwait, Lithuania, Netherlands, Norway, Poland, Russia, Slovakia, Spain and Switzerland.
Recall date
November 7, 2018
Classification
Class II
Status
Ongoing
Agency
FDA (device)
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