Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-2857-2011

Global Focus Marketing and Distribution, Silencer S2200 Centrifuge

Global Focus Marketing & Develop / initiated 2011-07-15 / Terminated / root cause: manufacturing process

Global Focus Marketing & Develop began a recall of Global Focus Marketing and Distribution, Silencer S2200 Centrifuge on . The reason FDA records is "Potential for bucket and insert not seated on the rotor to cause the lid to break and buckets to be ejected". As of , the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number
Z-2857-2011
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Global Focus Marketing & Develop
Product
Global Focus Marketing and Distribution, Silencer S2200 Centrifuge
Product code
JQC Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use
Reason for recall
Potential for bucket and insert not seated on the rotor to cause the lid to break and buckets to be ejected.
Root cause tag
manufacturing process
FDA 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 [email protected]
Quantity in commerce
859 units
Distribution
Worldwide to USA, United Kingdom, Ireland, Canada, and China.
Product codes and lots
Serial numbers: 0493128 through 0798286, 98267203 through 06067205, and 04084R01 through 09274R01.