| Date Initiated by Firm | May 25, 2012 |
|---|
| Date Posted | July 26, 2012 |
|---|
| Recall Status1 |
Terminated 3 on May 13, 2014 |
| Recall Number | Z-2076-2012 |
|---|
| Recall Event ID |
62007 |
| 510(K)Number | K051641 |
|---|
| Product Classification |
Pump, infusion - Product Code FRN
|
| Product | Alaris PC unit model 8015
Product Usage: The device is labeled for prescription use only. |
|---|
| Code Information |
not available |
Recalling Firm/
Manufacturer |
CareFusion 303, Inc.
10020 Pacific Mesa Blvd
San Diego CA 92121-4386
|
| For Additional Information Contact |
858-617-4000 |
|---|
Manufacturer Reason
for Recall | The recall was initiated because the Alaris PC unit model 8015 has a component on the PC unit power supply board that is causing an error code(120.4630) "System Error" or "Missing Battery Error" at start up. The error code is accompanied by both an audible alarm and visual error messages on the PC unit screen. |
|---|
FDA Determined
Cause 2 | Component design/selection |
|---|
| Action | Carefusion sent an Urgent: Medical Device Recall Notification letter dated June 27, 2012 to all their customers who purchased the Alaris PC unit (model 8015). The letter identified the affected units, explanation of the problem, potential risk and actions to be taken. Customers were instructed to not return their devices. If customers observe either of the error messages identified in the letter, then they were instructed to remove the PC unit from use and contact the Carefusion Support Center. Carefusion will contact their facility by phone within 60 days of receiving this notification to schedule a visit to replace their affected power supply board on their PC unit. Customers were instructed to promptly complete and return the enclosed customer response card to expedite the corrective action process.
For questions and support contact:
CareFusion Support Center at 888-562-6018 for (Recall Related Questions), Customer Advocacy at 800-854-7128, Option 1, Option 1, Option 3 or email customerfeedback@carefusion.com for (Adverse Event Reports),
Technical Support at 888-812-3229 for (Technical Questions Regarding the Alaris System). |
|---|
| Quantity in Commerce | 112,912 units total (106,888 units in US) |
|---|
| Distribution | US Nationwide Distribution |
|---|
| Total Product Life Cycle | TPLC Device Report |
|---|
|
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
|
| 510(K) Database | 510(K)s with Product Code = FRN
|
|---|
