Recall Z-2857-2011 ยท JQC Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use
Global Focus Marketing & Develop
Global Focus Marketing and Distribution, Silencer S2200 Centrifuge
| Date | Jul 27, 2011 (initiated Jul 15, 2011) |
| Status | Terminated |
| Reason | Potential for bucket and insert not seated on the rotor to cause the lid to break and buckets to be ejected. |
| Root cause | 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 | 859 units |
| Distribution | Worldwide to USA, United Kingdom, Ireland, Canada, and China. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.