Safety Alerts for Human Medical Products > Silencer S2200 Centrifuge by Global Focus Marketing & Distribution, Ltd.: Class I Recall - Biohazardous Materials May be Released

Silencer S2200 Centrifuge by Global Focus Marketing & Distribution, Ltd.: Class I Recall - Biohazardous Materials May be Released

[Posted 07/27/2011]

AUDIENCE: Laboratory

ISSUE: There is a potential for a centrifuge’s bucket and insert not being seated on the rotor, breaking the lid and being forced out of the centrifuge. This could result in serious personal injury and damage to the surrounding area. See the Recall Notice for a list of affected serial numbers.

BACKGROUND: The Silencer 2200 is a general purpose centrifuge designed to be used in educational, biochemistry, clinical or industrial laboratories. Its applications include urine and blood separations or other procedures where solids, particles or cells are separated from liquids.

RECOMMENDATION: The model number can be found on the front of the centrifuge and the serial number can be found on the back. Customers who have one of these affected units should STOP using the S2200 and contact Global Focus Marketing & Distribution, Ltd.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

• Complete and submit the report Online: www.fda.gov/MedWatch/report.htm¹
• Download form² or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

[07/27/2011 - Recall Notice³ - FDA]

Go there...
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm265707.htm

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Silencer S2200 Centrifuge by Global Focus Marketing & Distribution, Ltd.: Class I Recall - Biohazardous Materials May be Released

[Posted 07/27/2011]

AUDIENCE: Laboratory

ISSUE: There is a potential for a centrifuge’s bucket and insert not being seated on the rotor, breaking the lid and being forced out of the centrifuge. This could result in serious personal injury and damage to the surrounding area. See the Recall Notice for a list of affected serial numbers.

BACKGROUND: The Silencer 2200 is a general purpose centrifuge designed to be used in educational, biochemistry, clinical or industrial laboratories. Its applications include urine and blood separations or other procedures where solids, particles or cells are separated from liquids.

RECOMMENDATION: The model number can be found on the front of the centrifuge and the serial number can be found on the back. Customers who have one of these affected units should STOP using the S2200 and contact Global Focus Marketing & Distribution, Ltd.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

• Complete and submit the report Online: www.fda.gov/MedWatch/report.htm¹
• Download form² or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

[07/27/2011 - Recall Notice³ - FDA]
 

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