Medical Device
Manufacturing
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Z-0564-06

Centrifuge Model CF-6 with lid lock. (Block Model Number OCT-VI). Units are distributed to Bloch Scientific...

Cygnus, LLC / initiated 2005-09-08 / Terminated / root cause: packaging

Cygnus LLC began a recall of Centrifuge Model CF-6 with lid lock. (Block Model Number OCT-VI). Units are distributed to Bloch Scientific, Holbrook, NY for Bloch''s customers MFT and Cascade on . The reason FDA records is "When device was packaged, too much expanding foam was added causing the lid to deform and causing the lid locking mechanism to be out of alignment". As of , the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number
Z-0564-06
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Cygnus, LLC
Product
Centrifuge Model CF-6 with lid lock. (Block Model Number OCT-VI). Units are distributed to Bloch Scientific, Holbrook, NY for Bloch''s customers MFT and Cascade.
Product code
JQC Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use
Reason for recall
When device was packaged, too much expanding foam was added causing the lid to deform and causing the lid locking mechanism to be out of alignment.
Root cause tag
packaging
FDA root cause
Other
Action
A recall notice was sent to Bloch Scientific on September 8, 2005. Bloch further distributed the product to MTF, Cascade and will conduct a sub-recall
Quantity in commerce
110 units
Distribution
All product was shipped domestically to the firm''s distributor: Block Scientific, 1170 Lincoln Ave., Unit 11, Holbrook, NY 11741
Product codes and lots
Serial Numbers: Labeled for MFT --  033824; 033825; 033827 through 033840; 033842 through 033844; 033852 through 033855; 033857 through 033863; 034411 through 034415; 034417 through 034445; 08296594 through 08296608.  Labeled for Cascade --  033690; 033989; 034109; 033942 through 033956; 033958 through 033960; 034119 through 034128.