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U.S. Department of Health and Human Services

Class 2 Device Recall PSD/4 Syringe Drive module

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  Class 2 Device Recall PSD/4 Syringe Drive module see related information
Date Initiated by Firm August 24, 2005
Date Posted October 22, 2005
Recall Status1 Terminated 3 on March 24, 2006
Recall Number Z-0087-06
Recall Event ID 33435
Product Classification Analyzer, Chemistry (Sequential Multiple, Continuous Flow) Clinical Use - Product Code JJC
Product Y-valve and T-valve, PSD/4 Syringe Drive Module parts.
Code Information catalog number 7427-01 (Y-valve), catalog number 7990-01 (T-valve), catalog number 51863-01-IL (PSD/4 with valve and syringe), no 510k number.  For 7427-01 (Lot number, date of manufacture): 277702, 4/29/2003; 282550A, 8/11/2003; 282550, 8/13/2003; 286630, 10/1/2003; 287449, 10/20/2003; 287137, 10/20/2003; 287949, 12/18/2003; 301809, 6/30/2004; 305599, 8/19/2005; 309328, 11/5/2004; 313276, 12/17/2004; 314662, 3/7/2005; 317940, 4/6/2005; 319506, 4/11/2005; 321121, 5/6/2005; 324204, 6/23/2005; 325483, 7/20/2005.  For 7990-01: 277703, 4/30/2003; 283119, 9/30/2003 291279, 1/7/2004; 303942, 7/19/2004; 303687, 7/19/2004; 318833, 3/24/2005; 319684, 5/5/2005.
Recalling Firm/
Manufacturer
Hamilton Co
4970 Energy Way
Reno NV 89502-4123
Manufacturer Reason
for Recall
The product valve has a high probability of deforming and may result in leakage during use.
FDA Determined
Cause 2
Other
Action Recall initiated on 08/24/2005. The firm issued notification to its consignees via overnight letter, and via e-mail for its distributor (Hamilton Bonaduz).
Quantity in Commerce 271 Y and 78 T valves were distributed.
Distribution One distributor and 8 consumers received this product in CA, MA, MI, WI, Japan and Switzerland.
Total Product Life Cycle TPLC 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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