Recall Z-0362-2017
Hospira Inc. · initiated March 16, 2011
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Symbiq Two Channel Infuser; an Rx medical device infusion pump used to administer I.V. fluids. List number 16027. Note that Hospira retired this pump June 30, 2015. 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: 14589022 14589046 14589066 14589083 14589108 14589117 14589154 14589165 14589169 14589172 14589232 14589235 14589264 14589276 14589277 14589293 14589321 14589328 14589346 14589382 14589399 14589431 14589451 14589587 14589642 14589692 14589696 14589720 14589721 14589733 14589761 14589779 14589792 14589802 14590003 14590023 14590035 14590117 14590153 14590279 14590287 14590315 14590324 14590409 14590436 14590445 14590469 14590484 14590507 14590526 14590527 14590531 14590542 14590544 14590548 14590568 14590582 14590677 14590687 14590693 14590736 14590796 14590830 14590877 14590905 14590947 14590956 14591038 14591080 14591081 14591182 14591210 14591386 14591406 14591442 14591460 14591473 14591496 14591500 14591518 14591574 14591583 14591599 14591632 14591634 14591672 14591673 14591678 14591696 14591697 14591723 14591741 14591760 14591761 14591762 14591773 14591783 14591815 14591819 14591820 14591828 14591841 14591861 14591870 14591876 14591879 14591880 14591886 14591887 14591899 14591906 14591914 14591928 14591930 14591950 14591972 14591995 14591997 14592016 14592034 14592041 14592065 14592067 14592068 14592069 14592075 14592090 14592095 14592112 14592116 14592122 14592125 14592143…
Reason for recall
May go to a white screen due to a problem with the SOM2 module. A white screen is a diagnostic screen displayed to the user as part of the safety shutdown procedure of the device. The infusion and the processor stop, sound a 3 minute audible alarm from the backup buzzer and deactivate the couch screen and the automated loading/unloading of cassettes. Delay or interruption of therapy.
FDA-determined cause: Device Design
Action taken
Hospira sent an Urgent Device Recall Letters, dated February 5, 2013, to all affected customers. Customers were directed to notify their consignees if they further distributed the product and confirm they have done so by return of the reply form. Healthcare professionals were to contact Stericycle. Hospira discontinued support of these devices as of June 30, 2015. Customers with questions were instructed to call 1-800-201-9064. For questions regarding this recall call 224-212-4892.
Details
- Recall number
- Z-0362-2017
- Initiated
- March 16, 2011
- Terminated
- November 28, 2016
- Product code
- FRN – Pump, Infusion
- Quantity
- 10897
- Distribution
- Worldwide Distribution - US (nationwide) and Canada
- Recalling firm
- Hospira Inc., Lake Forest, IL
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0361-2017 Class II | Symbiq One Channel Infuser; an Rx medical device infusion pump used to administer I.V.…May go to a white screen due to a problem with the SOM2 module. A white screen is a diagnostic screen… | 03/16/2011Terminated |