Recall Z-0372-2014 ยท FRN Pump, Infusion
Hospira Inc.
*** 1) SYMBIQ One-Channel Infuser; *** 2) SYMBIQ Two-Channel Infuser; *** E09 batteries can be identified by the "E09" that is printed beneath the bar code and at the end of the serial number along the bottom of the label found on each battery; *** E10 batteries can be identified by the "E10" that is printed beneath the bar code and at the end of the serial number along the bottom of the label
| Date | Nov 20, 2013 (initiated Aug 28, 2013) |
| Status | Terminated |
| Reason | Hospira shipped the incorrect replaceable battery pack (Part No: HSP3566-E10) instead of the correct E09 battery pack (Part No. HSP3566-E09) for the Symbiq Single and Dual Channel Infusers. |
| Root cause | Employee error |
| Action | The firm, Hospira, sent an "URGENT MEDICAL DEVICE CORRECTION" letter dated August 28, 2013 to its customers. Hospira contracted with Stericycle, Inc., in Indianapolis, IN for customer notification, response, tracking, returns, effectiveness checks and destruction of returned product starting on August 28, 2013. The letter described the product, problem and actions to be taken. Customers were instructed to: 1) complete and return the attached reply form via fax to 1-866-470-3291 or e-mail to Hospira2921@stericycle.com, even if you do not currently have the affected batteries; 2) contact Steric |
| Quantity | 59 batteries |
| Distribution | US Distribution in states of: : KY, MN, ND, NJ, NY, PA, and SD. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K110901 | SYMBIQ INFUSION AND ADMINSTRATION SET Hospira, Inc., Mar 5, 2012 |