Battery Pack Used with the Capnostream"20 and Capnostream"20p Patient Monitor, Battery Packs Model Number - 016400, 0105

FDA device recall Z-1577-2016 · posted 2016-05-12 · Terminated

Recall details

Recalling firm

Medtronic

Reason for recall

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.

Action taken

Medtronic sent an Urgent Medical Device Recall letter dated April 2016, by postal mail or courier to all affected customers. The letter instructed users to remove and properly dispose of current batteries. If product was further distributed customers were instructed to forward the recall letter. Customers were asked to completed and return the Acknowledgement and Receipt Form by fax or email. Customers with questions should contact Technical Services at 800-635-5267, option 1, ten 1 and 1 or by email at HQTSWEB@COVIDIEN.com. For questions regarding this recall call 303-876-8859.

Root cause

Process change control

Status

Terminated

Product code

CCK

Quantity affected

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, U

Date initiated

2016-04-13

Date posted

2016-05-12

Date terminated

2017-10-17

Location

Boulder, CO

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