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U.S. Department of Health and Human Services

Class 1 Device Recall Silencer S2200 Centrifuge

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  Class 1 Device Recall Silencer S2200 Centrifuge see related information
Date Initiated by Firm July 15, 2011
Date Posted July 27, 2011
Recall Status1 Terminated 3 on November 06, 2013
Recall Number Z-2857-2011
Recall Event ID 59288
Product Classification centrifuge - Product Code JQC
Product Global Focus Marketing and Distribution, Silencer S2200 Centrifuge
Code Information Serial numbers: 0493128 through 0798286, 98267203 through 06067205, and 04084R01 through 09274R01.
Recalling Firm/
Manufacturer		 Global Focus Marketing & Develop
2280 Springlake Rd Ste 106
Dallas TX 75234-5830
For Additional Information Contact Charles Lovelady
972-247-1833
Manufacturer Reason
for Recall		 Potential for bucket and insert not seated on the rotor to cause the lid to break and buckets to be ejected.
FDA Determined
Cause 2		 Nonconforming Material/Component
Action Global Focus Marketing and Distribution, Ltd issued a press release on 07/19/11 and a URGENT: DEVICE RECALL letter was mailed to the firm's customers on 07/15/11 and 07/21/11. Discontinue use. For questions, contact: (800) 323-4306 or silencer@gfmd.com
Quantity in Commerce 859 units
Distribution Worldwide to USA, United Kingdom, Ireland, Canada, and China.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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