The Hospira Symbiq Infusion System is intended for the delivery of fluids, solutions, drugs, agents, nutritionals, elect
FDA device recall Z-1847-2013 · posted 2013-08-01 · Terminated
Recall details
- Recalling firm
- Hospira Inc.
- Reason for recall
- The devices secondary audio signal fails to activate.
- Action taken
- Hospira sent a Urgent Device Field Correction letter dated February 4, 2013, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. In addition, letters were sent by e-mail to ECRI, NRAC, Noblis and ISMP for notification of their members and posting on their websites February 5, 2013. The letter was also posted on the Hospira website February 4, 2013. Customers were requested to return a reply form indicating they have received the letter and notified their users. For further inquiries please contact Hospira Global Complaint Management at 1-800-441-4100 ( 8am - 5pm CST, M-F) to report adverse events or product complaints, or Hospira Advanced Knowledge Center at 1-800-241-4002, option 4 for additional information or technical assistance. ( 24hrs a day / 7 days a week.
- Root cause
- Process control
- Status
- Terminated
- Product code
- FRN
- Quantity affected
- 2,791 units
- Distribution
- US Distribution including the states of AL, CA, CT, DE, FL, HI, IA, IL, IN, LA, MA, MD, ME, MI, MN, NC, NJ, NY, PA, SD, TX and WA.
- Date initiated
- 2013-02-04
- Date posted
- 2013-08-01
- Date terminated
- 2016-11-07
- Location
- Lake Forest, IL
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SYMBIQ INFUSION AND ADMINSTRATION SET (K110901) | Hospira, Inc. | 2012-03-05 |