Global Focus Marketing & Distribution, Ltd. is initiating a recall of the Silencer ® S2200 model centrifuge due to a reported incident of a 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. Biohazardous materials may be released into the immediate area of the projectiles and caution should be utilized. .
There has been one reported incident and no reports of injury or property damage to date.
Customers who have one of the affected units should discontinue use of the S2200 and contact Global Focus Marketing & Distribution, Ltd at (800) 323-4306 or silencer@gfmd.com.
Normal business hours are 8:00AM to 4:30 PM Central Time, Monday through Friday, excluding holidays.
Global Focus Marketing & Distribution, Ltd. has notified the FDA of its decision to voluntarily recall the affected product.
Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.
- Online: https://www.accessdata.fda.gov/scripts/medwatch/medwatch-online.htm.
- Regular Mail: use postage-paid, pre-addressed Form FDA 3500 available at: http://www.fda.gov/Safety/MedWatch/HowToReport/DownloadForms/default.htm Mail to address on the pre-addressed form.
- Fax: 1-800-FDA-0178.
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