Recall Z-1577-2016 ยท CCK Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
Medtronic
Battery Pack Used with the Capnostream"20 and Capnostream"20p Patient Monitor, Battery Packs Model Number - 016400, 010520. Battery Pack used with the Capnostream"20 and Capnostream"20p Patient Monitor. The battery pack powers the monitor when AC power is not available or when monitoring is required during intra-hospital transfer of patients. The Capnostream"20 and Capnostream"20p is a combined ca
| Date | May 12, 2016 (initiated Apr 13, 2016) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Process change control |
| Action | 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. |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K123690 | CAPNOSTREAM20P WITH HIFI C02 MONITORING Oridion Medical 1987 , Ltd., Aug 5, 2014 |