Recall Z-0361-2017
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 One Channel Infuser; an Rx medical device infusion pump used to administer I.V. fluids. List number 16026. 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: 14339017 14339063 14339071 14339076 14339078 14339084 14339086 14339087 14339091 14339095 14339097 14339104 14339105 14339108 14339114 14339115 14339119 14339125 14339130 14339140 14339142 14339145 14339146 14339149 14339158 14339171 14339172 14339192 14339195 14339200 14339271 14339283 14339304 14339308 14339322 14339327 14339328 14339344 14339358 14339359 14339362 14339367 14339369 14339370 14339377 14339380 14339384 14339389 14339391 14339392 14339396 14339407 14339411 14339413 14339414 14339415 14339422 14339424 14339426 14339504 14339517 14339519 14339524 14339529 14339534 14339545 14339569 14339572 14339664 14339669 14339681 14339723 14339789 14339849 14339905 14339921 14339932 14339933 14339985 14339987 14339989 14339990 14340000 14340002 14340004 14340006 14340008 14340017 14340027 14340038 14340039 14340041 14340048 14340053 14340058 14340060 14340063 14340065 14340067 14340071 14340072 14340077 14340078 14340080 14340084 14340088 14340089 14340103 14340105 14340106 14340123 14340125 14340126 14340128 14340138 14340150 14340153 14340167 14340170 14340180 14340186 14340192 14340205 14340214 14340217 14340223 14340232 14340255 14340272 14340273 14340277 14340287 14340377…
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-0361-2017
- Initiated
- March 16, 2011
- Terminated
- November 28, 2016
- Product code
- FRN – Pump, Infusion
- Quantity
- 10,337
- 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-0362-2017 Class II | Symbiq Two 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 |