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U.S. Department of Health and Human Services

Class 2 Device Recall

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 Class 2 Device Recallsee related information
Date Initiated by FirmDecember 29, 2003
Date PostedFebruary 04, 2004
Recall Status1 Terminated 3 on April 08, 2004
Recall NumberZ-0512-04
Recall Event ID 28016
Product Classification Tubes, Vials, Systems, Serum Separators, Blood Collection - Product Code JKA
Product50 mL sterile plastic centerfuge tubes.
Code Information Codes 3250, 3250P, 3252, 3252P and the lot numbers: 69766 through 87512 which were manufactured from 02/03/03 - 09/22/2003  Also:  3250-DES1, 3250P-DES1, 3252-DES1, 3252P-DES1  3250P-MIS1, 3252P-MIS1  3250P-USA1, 3252P-USA1 
FEI Number 3000013175
Recalling Firm/
Manufacturer		 Stockwell Scientific Inc
7325 E Evans Rd
Scottsdale AZ 85260-3101
For Additional Information ContactRobert Bajadek
480-951-1111
Manufacturer Reason
for Recall		Tubes are brittle and break during centerfuging specimens.
FDA Determined
Cause 2		Other
ActionFirm sent a recall letter to all customers 12/30/2003 requesting return of existing stock and subrecall of subdistributed product.
Quantity in Commerce3762 cases (500 tubes/cs)
DistributionNationwide and Canada
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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