Recall Z-0070-2013
Hospira Inc. · initiated August 29, 2012
Class I – dangerous or defective products that could cause serious health problems or death
Product
Symbiq Two Channel Infuser; an Rx medical device infusion pump used to administer I.V. fluids; Hospira, Inc., Lake Forest, IL 60045 USA, Made in Costa Rica; List Number 16027-01 Device is a general purpose infusion pump designed to deliver fluids, solutions, medications, agents, nutritionals, electrolytes, blood and blood products for parenteral, enteral, intravenous, intra-arterial, subcutaneous, epidural
Codes / lots: List Number 16027-01, all serial numbers
Reason for recall
The Symbiq pump touchscreen may not respond to user selection, may experience a delayed response, or may register a different value from the value selected by the user. Failure of the touchscreen to respond to user input could result in a delay in therapy or result in over delivery or under delivery of medication if the user does not confirm the programmed values on the pump's confirmation screen prior to starting the infusion.
FDA-determined cause: Device Design
Action taken
Hospira sent an Urgent Device Correction letter dated August 29, 2012, to all affected customers. Customers have been informed of reports that the Symbiq pump touchscreen may not respond to user selection, may experience a delayed response, or may register a different value from the value selected by the user. Failure of the touchscreen to respond to user input could result in a delay in therapy or result in over delivery or under delivery of medication if the user does not confirm the programmed values on the pump's confirmation screen prior to starting the infusion. The users were instructed to complete and fax the enclosed reply card to 1-888-943-5180 or email it to Hospira194@stericycle.com indicating the number of infusers at the facility and if they notified their users throughout the facility. Wholesalers were asked to notify their customers. If they have further distributed the affected product, they should notify their accounts and ask them to contact Stericycle at 1-877-272-6141 to receive a reply form. For questions regarding this recall call 224-212-2000.
Details
- Recall number
- Z-0070-2013
- Initiated
- August 29, 2012
- Posted by FDA
- October 19, 2012
- Terminated
- March 15, 2017
- Product code
- FRN – Pump, Infusion
- Quantity
- 14,067 units
- Distribution
- Worldwide Distribution - USA (nationwide) Puerto Rico and Internationally to Canada
- Recalling firm
- Hospira Inc., Lake Forest, IL
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0069-2013 Class I | Symbiq One Channel Infuser; an Rx medical device infusion pump used to administer I.V.…The Symbiq pump touchscreen may not respond to user selection, may experience a delayed response, or may… | 08/29/2012Terminated |