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Battery Pack Used with the Capnostream"20 and… recallZ-1577-2016 · Medtronic · initiated Apr 13, 2016

Class I Terminated All recalls posted in May 2016

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Medtronic or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was 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.

FDA root cause category: Process change control

What the company is doing

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 [email protected]. For questions regarding this recall call 303-876-8859.

Recall details

Recall number
Z-1577-2016
Recall class
Class I (most serious)
Status
Terminated
Initiated by the company
Apr 13, 2016
Posted by the FDA
May 12, 2016
Recalling firm
Medtronic
Quantity
9,817 batteries (8,170 with monitors and 1,647 as spare parts)
Product code
CCK
FDA submissions
K123690
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.

Product description

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 capnograph/pulse oximeter monitor and its accessories are intended to provide professionally trained health care providers with continuous, non-invasive measurement and monitoring of carbon dioxide concentration of the expired and inspired breath and respiration rate, and with continuous non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate. It is intended for use with neonatal, pediatric, and adult patients in hospitals, hospital-type facilities, and intra-hospital transport environments

Code information (models, lots, serial numbers)

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

Other devices under the same FDA submission

3 devices cleared under K123690 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Sources and updates

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