Alaris PC Unit, Infusion Pump Model 8000, Part No. TC10005092
FDA device recall Z-1239-2016 · posted 2016-03-24 · Terminated
Recall details
- Recalling firm
- CareFusion 303, Inc.
- Reason for recall
- CareFusion is recalling the Alaris PC unit because a component on the PC unit power supply may cause a "System Error" or "Missing Battery" error code (120.4630).
- Action taken
- A customer notification letter dated 2/25/16 will be sent to all their customers who purchased the Alaris PC unit (Model 8000) to inform them that CareFusion is recalling it because a component on the PC unit power supply board may cause a "System Error" or "Missing Battery" error code (120.4630). The letter informs the customers of the potential risk involved and the actions to be taken. Customers with recall related questions are instructed to call CareFusion Support Center at (888) 562-6018, 7am-4pm PST, Mon-Fri or email at supportcenter@carefusion.com. Customers with clinical inquires, product complaints or clinical troubleshooting are instructed to contact customer advocacy at (888) 812-3266, 24 hrs/day, 7 days/wk or email at customerfeedback@carefusion.com. Customers with technical questions regarding the Alaris system are instructed to contact technical support at (888) 812-3229, 6am-5pm PST, Mon-Fri or email at DL-US-INF-TechSupport@carefusion.com.
- Root cause
- Under Investigation by firm
- Status
- Terminated
- Product code
- FRO
- Quantity affected
- 170 units
- Distribution
- Nationwide in US: AR, AZ, CA, FL, GA, IN, KY, MD, MI, MN, MO, NJ, NM, NY, OH, OR, PA, SC, TN, TX, VA, WI.
- Date initiated
- 2016-02-12
- Date posted
- 2016-03-24
- Date terminated
- 2017-06-23
- Location
- San Diego, CA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ALARIS SYSTEM PC UNIT, MODEL 8001 (K051641) | Cardinal Health, Alaris Products | 2005-10-20 |