ACCU-CHEK Spirit Combo insulin infusion pump sold as part of Accu-Chek Combo System Product Usage: The ACCU-CHEK Combo S
FDA device recall Z-0146-2015 · posted 2014-10-29 · Terminated
Recall details
- Recalling firm
- Roche Diagnostics Operations, Inc.
- Reason for recall
- The insulin pump may lose time and date settings during a power interruption (such as a battery change) due to a faulty capacitor. If the capacitor fails, the time and date will return to default setting. Though the pump prompts customers to confirm the time and date, if the user does not recognize the time and date have returned to default, a shift of their basal rate time block could occur.
- Action taken
- Roche sent an "URGENT MEDICAL DEVICE CORRECTION" letter dated September 25, 2014 via UPS Ground (receipt required) to the consignees. The letter included a description of the reason for recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification. No product returns were expected. For questions, contact the ACCU-CHEK Customer Care Service Center at 1-800-688-4578.
- Root cause
- Equipment maintenance
- Status
- Terminated
- Product code
- LZG
- Quantity affected
- 8116
- Distribution
- US Nationwide Distribution in the states of CA, CT, IA, NV, OH, IN, WI, GA, MO, NY, VA, LA, ME, TX, NC, ND, SD, NJ, CO, AL, SC, IL, KY, FL, OR, MN, MD, MS, AR, WV, WA, TN, CT, ID, KS, MI, PA, UT, MA,
- Date initiated
- 2014-09-25
- Date posted
- 2014-10-29
- Date terminated
- 2018-01-10
- Location
- Indianapolis, IN
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ACCU-CHECK COMBO SYSTEM (K111353) | Roche Diagnostics | 2012-07-17 |