Recall Z-1847-2013
Hospira Inc. · initiated February 4, 2013
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
The Hospira Symbiq Infusion System is intended for the delivery of fluids, solutions, drugs, agents, nutritionals, electrolytes, blood and blood products via parenteral, enteral, intravenous, intra-arterial, subcutaneous, epidural, or irrigation routes of administration.
Codes / lots: *** 1) List Number 16206, Serial Numbers: 0017234975 , 0017234978 , 0017234979 , 0017234980 , 0017234981 , 0017234982 , 0017234983 , 0017234984 , 0017234985 , 0017234986 , 0017234988 , 0017234991 , 0017234992 , 0017234993 , 0017234994 , 0017234995 , 0017234996 , 0017234997 , 0017234998 , 0017234999 , 0017235001 , 0017235002 , 0017235003 , 0017235004 , 0017235005 , 0017235006 , 0017235007 , 0017235008 , 0017235009 , 0017235010 , 0017235011 , 0017235014 , 0017235015 , 0017235016 , 0017235017 , 0017235018 , 0017235019 , 0017235020 , 0017235021 , 0017235022 , 0017235023 , 0017235024 , 0017235025 , 0017235026 , 0017235028 , 0017235029 , 0017235030 , 0017235031 , 0017235032 , 0017235033 , 0017235034 , 0017235035 , 0017235036 , 0017235037 , 0017235038 , 0017235039 , 0017235041 , 0017235042 , 0017235043 , 0017235044 , 0017235045 , 0017235046 , 0017235048 , 0017235049 , 0017235050 , 0017235051 , 0017235052 , 0017235053 , 0017235054 , 0017235056 , 0017235057 , 0017235058 , 0017235060 , 0017235062 , 0017235063 , 0017235064 , 0017235065 , 0017235066 , 0017235067 , 0017235068 , 0017235069 , 0017235070 , 0017235071 , 0017235073 , 0017235074 , 0017235076 , 0017235077 , 0017235079 , 0017235080…
Reason for recall
The devices secondary audio signal fails to activate.
FDA-determined cause: Process control
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.
Details
- Recall number
- Z-1847-2013
- Initiated
- February 4, 2013
- Posted by FDA
- August 1, 2013
- Terminated
- November 7, 2016
- Product code
- FRN – Pump, Infusion
- Quantity
- 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.
- Recalling firm
- Hospira Inc., Lake Forest, IL