News

FDA Recall: Symbiq One and Two-Channel Infusers

Company:> Symbiq Product:> One and Two-Channel Infusers Recall Class:> Class I Date Recall Initiated:> March 26th 2010 Model Numbers: > 16026 Symbiq One-Channel Infuser 16027 Symbiq Two-Channel Infuser Dates of Distribution:> December 23, 2006 to January 22, 2010 Use:> The Symbiq One and Two Channel Infusers are infusion pumps intended for the delivery of fluids, solutions, drugs, agents, nutritionals, electrolytes, blood and blood products via parenteral, enteral, intravenous, intra-arterial, subcutaneous, epdidural, or irrigation routes of administration. The systems are available as a one-channel or a two-channel infuser and may be connected to configure a three or four channel pump. The cassette based system is powered by either AC power or can be powered by a rechargeable battery. The Symbiq Infusion Systems deliver basis therapy or advances therapies such as multi-step, intermittent, and interchanneling sequencing. Recalling Firm:> Hospira Inc., 775 Jarvis Drive, Morgan Hill, California, 95037 Reason for Recall: There is potential for unrestricted flow of fluid or medication if the administration set (cassette) is removed before the cassette carriage fully opens and the slide/roller clamp is not closed. Additionally, when unrestricted flow occurs, the "Check Flow Stop" alarm, which is designed to notify users of a free flow condition, may not function as intended and may not provide appropriate warning to users. Unrestricted flow of medication and/or other therapy has the potential to cause life-threatening effects and/or critical patient injury, especially in specific patient groups, such as critically ill patients, patients with congestive heart failure and/or neonates. The design of this device is being evaluated. The actions required under this recall will be supplemented with a long term solution to the "Check Stop Flow" alarm malfunction on a later date. Hospira is reinforcing that it is imperative that clinicians using the Symbiq devices adhere to the operating instructions for removing the cassette from the infuser in order to mitigate free flow until a final correction is implemented. For proper cassette removal procedures, visit www.fda.gov/medicaldevices. Via MD Publishing

Thu Nov 25 2010By Andrea Cole

[b]Company:[/b] Symbiq [b]Product:[/b] One and Two-Channel Infusers [b]Recall Class:[/b] Class I [b]Date Recall Initiated:[/b] March 26th 2010 [b]Model Numbers: [/b] 16026 Symbiq One-Channel Infuser 16027 Symbiq Two-Channel Infuser [b]Dates of Distribution:[/b] December 23, 2006 to January 22, 2010 [b]Use:[/b] The Symbiq One and Two Channel Infusers are infusion pumps intended for the delivery of fluids, solutions, drugs, agents, nutritionals, electrolytes, blood and blood products via parenteral, enteral, intravenous, intra-arterial, subcutaneous, epdidural, or irrigation routes of administration. The systems are available as a one-channel or a two-channel infuser and may be connected to configure a three or four channel pump. The cassette based system is powered by either AC power or can be powered by a rechargeable battery. The Symbiq Infusion Systems deliver basis therapy or advances therapies such as multi-step, intermittent, and interchanneling sequencing. [b]Recalling Firm:[/b] Hospira Inc., 775 Jarvis Drive, Morgan Hill, California, 95037 Reason for Recall: There is potential for unrestricted flow of fluid or medication if the administration set (cassette) is removed before the cassette carriage fully opens and the slide/roller clamp is not closed. Additionally, when unrestricted flow occurs, the "Check Flow Stop" alarm, which is designed to notify users of a free flow condition, may not function as intended and may not provide appropriate warning to users. Unrestricted flow of medication and/or other therapy has the potential to cause life-threatening effects and/or critical patient injury, especially in specific patient groups, such as critically ill patients, patients with congestive heart failure and/or neonates. The design of this device is being evaluated. The actions required under this recall will be supplemented with a long term solution to the "Check Stop Flow" alarm malfunction on a later date. Hospira is reinforcing that it is imperative that clinicians using the Symbiq devices adhere to the operating instructions for removing the cassette from the infuser in order to mitigate free flow until a final correction is implemented. For proper cassette removal procedures, visit www.fda.gov/medicaldevices. [url=https://www.medicaldealer.com]Via MD Publishing[/url]

FDA Recall: Symbiq One and Two-Channel Infusers

Site Links

Subscribe To eNews