Date Initiated by Firm | March 28, 2006 |
Date Posted | June 22, 2006 |
Recall Status1 |
Terminated 3 on December 21, 2006 |
Recall Number | Z-1169-06 |
Recall Event ID |
35292 |
Product Classification |
syringe HPLC - Product Code JQW
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Product | Syringe, 62RNR 2.5 Microliter Syringe, with needle point style 3 (blunt needle point for use with HPLC injection valves and for sample pipetting) Part #: 87942. |
Code Information |
Lot 340007 and 342081 |
Recalling Firm/ Manufacturer |
Hamilton Co 4970 Energy Way Reno NV 89502-4123
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For Additional Information Contact | Wayne McAuliffe 775-858-3000 |
Manufacturer Reason for Recall | There is an error in the marking of the graduated divisions on syringes in affected lots that shows an amount that is double the actual volume of the syringe |
FDA Determined Cause 2 | Other |
Action | On 3/28/06, the firm initiated the recall and its notification was via letters explaining the reason for the recall and requesting the product be returned. |
Quantity in Commerce | 63 units |
Distribution | Worldwide-The product was distributed to 28 U.S. consignees and 3 foreign consignees. (Canada, Switzerland, Japan)
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Total Product Life Cycle | TPLC Device Report |
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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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