Recall Z-2055-2016
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
Symbiq One Channel Infuser; an Rx medical device infusion pump used to administer I.V. fluids Device is a general purpose infusion pump designed to deliver fluids, solutions, medications, agents, nutritionals, electrolytes, blood and blood products for parenteral administration; and various solution through enteral, intravenous, intra-arterial, subcutaneous, and pathways.
Codes / lots: 14339017 14339062 14339063 14339066 14339071 14339072 14339076 14339078 14339079 14339084 14339086 14339087 14339089 14339090 14339091 14339095 14339097 14339098 14339099 14339102 14339104 14339105 14339107 14339108 14339111 14339113 14339114 14339115 14339116 14339119 14339121 14339125 14339128 14339130 14339133 14339136 14339138 14339139 14339140 14339141 14339142 14339145 14339146 14339149 14339150 14339152 14339154 14339155 14339158 14339168 14339171 14339172 14339179 14339180 14339185 14339190 14339192 14339194 14339195 14339200 14339201 14339205 14339216 14339228 14339230 14339231 14339233 14339236 14339243 14339246 14339248 14339250 14339251 14339254 14339262 14339271 14339274 14339280 14339283 14339287 14339291 14339293 14339299 14339302 14339304 14339308 14339322 14339327 14339328 14339344 14339346 14339348 14339349 14339351 14339358 14339359 14339361 14339362 14339367 14339369 14339370 14339371 14339372 14339373 14339377 14339378 14339380 14339384 14339388 14339389 14339391 14339392 14339394 14339395 14339396 14339399 14339401 14339407 14339408 14339409 14339410 14339411 14339413 14339414 14339415 14339422 14339423 14339424 14339426 14339504 14339517 14339519 14339522…
Reason for recall
Frequent Proximal Occlusion Alarms (POAs) occurring on Symbiq devices with list numbers 16026 and 16027. When there are false alarms, the pump will continue to alarm even though there is no occlusion present. False POAs could result in a delay/interruption in therapy, and require the clinician to reset the alarm multiple times or to replace the pump.
FDA-determined cause: Software design
Action taken
Hospira sent letters on May 2, 2013, to customers informing them of the discontinuation of sales, service, and support for the Symbiq pump were sent via traceable mailing to all affected customers. For questions regarding this recall call 224-212-4892.
Details
- Recall number
- Z-2055-2016
- Initiated
- February 4, 2013
- Terminated
- September 12, 2016
- Product code
- FRN – Pump, Infusion
- Quantity
- 20,311
- Distribution
- Worldwide Distribution - USA (nationwide)
- Recalling firm
- Hospira Inc., Lake Forest, IL
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-2056-2016 Class II | Symbiq Two Channel Infuser; an Rx medical device infusion pump used to administer I.V.…Frequent Proximal Occlusion Alarms (POAs) occurring on Symbiq devices with list numbers 16026 and 16027.… | 02/04/2013Terminated |