Symbiq Two Channel Infuser — Class II medical device recall Z-0354-2017
Terminated recall by Hospira Inc., reported 2016-11-09, distributed nationwide. Hospira has received reports of Malfunction S205 Backup Battery Failure alarms in Symbiq v3.13 pumps. This iss
| Recall number | Z-0354-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Hospira Inc., Lake Forest, IL, United States |
| Recall initiated | 2013-02-05 |
| Classified | 2016-11-03 |
| Reported by FDA | 2016-11-09 |
| Terminated | 2016-12-15 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA |
| Quantity | 15,285 |
| Reason classes | device malfunction |
| Serial numbers | 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 and 475 more |
Product
Symbiq Two Channel Infuser; an Rx medical device infusion pump used to administer I.V. fluids; Product List Number 16027
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0354-2017. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.