Recall Z-0353-2017
Hospira Inc. · initiated February 5, 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; Product List Number 16026
Codes / lots: Serial Numbers: 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…
Reason for recall
Hospira has received reports of Malfunction S205 Backup Battery Failure alarms in Symbiq v3.13 pumps. This issue to an incorrect installation of components on some of the Power Supply Controller (PSC) Boards distributed prior to September 2012. On pumps where incorrect installation of components has occurred, the backup battery power discharges and subsequently, the battery cannot be charged. Because of the battery depletion, or lack of charge, a visual and audible warning alarm, S205, is displayed. An S205 alarm is intended to notify the customer that the coin call battery, powering the backup buzzer, may need to be charged or replaced.
FDA-determined cause: Process control
Action taken
Hospira sent an Urgent Field Device Correction letter dated Feburay 5, 2013, to all affected customers. Hospira has implemented a correction to the manufacturing process to address this issue. Symbiq v3.13 pumps that have been shipped from Hospira since September 2012 and pumps that were upgraded to v3.13 in the Field after September 2012 are not impacted by this issue. If you are unsure of when you were shipped Symbiq v3.13 pumps or when your devices were upgraded, contact Hospira. Please complete the attached reply form and return it via fax number or e-mail address on the form, even if you do not currently have the impacted infuser. lease contact Stericycle at 1-866-201-9072 (M-F, Bam - 5pm EST) to obtain additional copies of the reply form. If you have further distributed these devices, please notify your accounts who may have received these infusers from you and ask them to contact Stericycle at 1-866-201-9072 (M-F, 8am- 5pm EST) to receive a reply form.
Details
- Recall number
- Z-0353-2017
- Initiated
- February 5, 2013
- Terminated
- December 15, 2016
- Product code
- FRN – Pump, Infusion
- Quantity
- 20,311
- Distribution
- Nationwide Distribution and Canada
- Recalling firm
- Hospira Inc., Lake Forest, IL
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0354-2017 Class II | Symbiq Two Channel Infuser; an Rx medical device infusion pump used to administer I.V.…Hospira has received reports of Malfunction S205 Backup Battery Failure alarms in Symbiq v3.13 pumps. This… | 02/05/2013Terminated |