Recall Z-0306-2017
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 Two 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: 14589003 14589008 14589009 14589012 14589013 14589014 14589015 14589017 14589020 14589022 14589028 14589030 14589031 14589033 14589034 14589035 14589043 14589046 14589048 14589049 14589050 14589053 14589057 14589060 14589063 14589064 14589066 14589068 14589072 14589078 14589082 14589083 14589086 14589092 14589095 14589100 14589101 14589105 14589108 14589110 14589111 14589116 14589117 14589118 14589121 14589127 14589131 14589133 14589135 14589136 14589137 14589139 14589140 14589141 14589144 14589148 14589149 14589151 14589154 14589159 14589160 14589161 14589162 14589165 14589167 14589169 14589172 14589174 14589175 14589178 14589180 14589188 14589195 14589203 14589204 14589206 14589214 14589215 14589221 14589222 14589225 14589228 14589230 14589231 14589232 14589233 14589235 14589237 14589241 14589245 14589248 14589252 14589257 14589258 14589259 14589260 14589264 14589265 14589267 14589270 14589272 14589273 14589275 14589276 14589277 14589278 14589279 14589282 14589283 14589285 14589292 14589293 14589294 14589296 14589298 14589302 14589303 14589304 14589317 14589320 14589321 14589323 14589327 14589328 14589331 14589339 14589346 14589350 14589351 14589353 14589355 14589356 14589360…
Reason for recall
Symbiq Infusers have the potential to experience a white screen during titration of a Keep Vein Open (KVO) delivery. This can allow the clinician to select the "NEXT" button prior to completion of the programming. If this error occurs, a delay in therapy could occur and potentially result in significant injury.
FDA-determined cause: Software design
Action taken
Hospira sent an Urgent Device Field Correction notice dated February 4, 2013, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to follow the steps provided in the letter while Hospira is developing a software change. Customers were asked to complete the attached reply form and return it via fax to the number on the form. Customers with questions were instructed to contact Stericycle at 1-888-201-9332. For questions regarding this recall call 224-212-4892.
Details
- Recall number
- Z-0306-2017
- Initiated
- February 4, 2013
- Terminated
- December 15, 2016
- Product code
- FRN – Pump, Infusion
- Quantity
- 35,596 devices in total
- Distribution
- Worldwide Distribution - USA (nationwide) and Canada
- Recalling firm
- Hospira Inc., Lake Forest, IL
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0305-2017 Class II | Symbiq One Channel Infuser; an Rx medical device infusion pump used to administer I.V.…Symbiq Infusers have the potential to experience a white screen during titration of a Keep Vein Open (KVO)… | 02/04/2013Terminated |