FDAClass IMay 18, 2016

Battery Pack Used with the Capnostream"20 and recall

Battery Pack Used with the Capnostream"20 and Capnostream"20p Patient Monitor, Battery Packs Model Number - 016400, 010520. Battery Pack used with the…

Why was Battery Pack Used with the Capnostream"20 and recalled?

Medtronic Respiratory & Monitoring Solutions Announces a Voluntary Recall of a Battery Pack Used with the Capnostream"20 and Capnostream"20p Patient Monitor Due to the Battery Pack Might Experience Thermal Runaway with the Potential of Fire Risk to the Monitor.

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?

Product # 016400; All SNs, irrespective of production date. Product # 010520; All SNs with production date starting 14.14

Product
Battery Pack Used with the Capnostream"20 and Capnostream"20p Patient Monitor, Battery Packs Model Number - 016400, 010520. Battery Pack used with the…
Recalling firm
Medtronic
Quantity
9,817 batteries (8,170 with monitors and 1,647 as spare parts)
Distribution
Nationwide Distribution to AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY. Product was also distributed worldwide. There is 1 VA customer.
Recall date
May 18, 2016
Classification
Class I
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls