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U.S. Department of Health and Human Services

Class 3 Device Recall

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 Class 3 Device Recallsee related information
Date Initiated by FirmSeptember 08, 2005
Date PostedFebruary 28, 2006
Recall Status1 Terminated 3 on April 17, 2007
Recall NumberZ-0564-06
Recall Event ID 34386
Product Classification Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use - Product Code JQC
ProductCentrifuge 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.
Code Information 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. 
FEI Number 1000121662
Recalling Firm/
Manufacturer		 Cygnus LLC
510 E 41st St
Paterson NJ 07504-1210
For Additional Information ContactMr. James Kearney
973-523-0668
Manufacturer 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.
FDA Determined
Cause 2		Other
ActionA 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 Commerce110 units
DistributionAll product was shipped domestically to the firm''s distributor: Block Scientific, 1170 Lincoln Ave., Unit 11, Holbrook, NY 11741
Total Product Life CycleTPLC 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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