Medical Devices
Global Focus Marketing & Distribution, Ltd., Silencer® S2200 Centrifuge
Recall Class: Class I
Date Recall Initiated: July 15, 2011
Product: Global Focus Marketing & Distribution, Ltd., Silencer® S2200 Centrifuge
| Sales Dates | Serial Numbers |
|---|---|
| March 17, 1995 - December 1, 1998 | 0493128 through 0798286 |
| November 6, 1998 through June 30, 2006 | 98267203 through 06067205 |
| March 31, 2004 through October 14, 2009 | (Demo units) 04084R01 through 09274R01 |
The model number can be found on the front of the centrifuge and the serial number can be found on the back.
Use: 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.
Recalling Firm:
Global Focus Marketing & Distribution, Ltd.
2280 Springlake Road, Suite 106
Dallas, Texas 75234-5830
Reason for Recall: 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. In addition, there is a risk that the ejected parts may contain biohazardous materials. This product may cause serious adverse health consequences, including death.
Public Contact: By phone at 1-800-323-4306 or by email at silencer@gfmd.com Normal business hours are 8:00 AM to 4:30 PM Central Time, Monday through Friday, excluding holidays.
FDA District: Dallas
FDA Comments:
Customers who have one of these affected units should STOP using the S2200 and contact Global Focus Marketing & Distribution, Ltd. by the methods listed above.
The firm mailed a recall letter to their customers on July 15, 2011 and they issued a press release on July 19, 2011 (see under Additional Links below).
Class I recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death.
Health care professionals and consumers may report adverse reactions or quality problems they experienced using these products to the FDA’s Safety Information and MedWatch Adverse Event Reporting Program either online, by regular mail or by FAX.
Additional Links:
