Recall Z-0372-2014
Hospira Inc. · initiated August 28, 2013
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
*** 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 found on each battery. Symbiq is a general-purpose infuser designed to deliver fluids, solutions, medications, agents, nutritionals, electrolytes, blood and blood products for parenteral, enteral, intra-arterial, subcutaneous, or irrigation routes of administration.
Codes / lots: *** 1) SYMBIQ One-Channel Infuser, List Number: 16026-04-01/02/03/04/25/26/43/44/45/46/51/52/53/54/55/56/57/58/65/66/69/70/77/78/79/80/81/82/83/84/87/88/89/90/93/94; *** 2) SYMBIQ Two- Channel Infuser, List Number: 16027-04-01/02/03/04/25/26/43/44/45/46/51/52/53/54/55/56/57/58/65/66/69/70/77/78/79/80/81/82/83/84/87/88/89/90/ 93/94; *** X) Battery Pack E10 Part Number: HSP3566-E10; *** X) Battery Pack E09 Part Number: HSP3566-E09
Reason for recall
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.
FDA-determined cause: Employee error
Action taken
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 Stericycle at 1-877-779-7810 (M-F, 8am - 5pm ET) if they require additional response forms; and, 3) return any affected batteries upon receipt of the new (correct) replacement batteries to Stericycle. Customers are also instructed to forward the recall information to any accounts that they may have shipped the affected batteries to and have them contact Stericycle to recieve a reply form and return label. For further inquiries, please contact Hospira Advanced Knowledge Center at 1-800-241-4002, option 6, availabel 24 hours a day/7 days per week.
Details
- Recall number
- Z-0372-2014
- Initiated
- August 28, 2013
- Posted by FDA
- November 20, 2013
- Terminated
- November 7, 2016
- Product code
- FRN – Pump, Infusion
- Quantity
- 59 batteries
- Distribution
- US Distribution in states of: : KY, MN, ND, NJ, NY, PA, and SD.
- Recalling firm
- Hospira Inc., Lake Forest, IL