Recall record at a glance
| Official record | Z-0354-2017 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class II |
| FDA record status | Terminated |
| Recalling firm | Hospira Inc. |
| Report date | Nov 9, 2016 |
| Recall initiation date | Feb 5, 2013 |
| Quantity | 15,285 |
| Location | Lake Forest, IL, United States |
Official product description
Symbiq Two Channel Infuser; an Rx medical device infusion pump used to administer I.V. fluids; Product List Number 16027
Why the product was recalled
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.
Distribution information
Nationwide Distribution and Canada
How to read the classification
FDA Class II indicates a situation in which use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious consequences is remote. The classification shown here comes from the FDA record.
Additional record details
Recall type: Voluntary: Firm initiated. Initial notification: Letter.
What to do next
If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.
About this record
Recall Lookup USA preserves the most complete source information successfully retrieved. We do not create missing facts or infer affected lots or VINs. The official record may still change, so use the identifier above when verifying current instructions.
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