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U.S. Department of Health and Human Services

Class 3 Device Recall Hamilton microliter syringe without needle

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 Class 3 Device Recall Hamilton microliter syringe without needlesee related information
Date Initiated by FirmMarch 28, 2006
Date PostedJune 22, 2006
Recall Status1 Terminated 3 on December 21, 2006
Recall NumberZ-1170-06
Recall Event ID 35292
Product Classification Microliter syringe - Product Code JQW
Product62 RNR Series 2.5 microliter syringe without needle, Part#: 7632-01
Code Information Lot 342268 and 345852
FEI Number 2915796
Recalling Firm/
Manufacturer		 Hamilton Co
4970 Energy Way
Reno NV 89502-4123
For Additional Information ContactWayne 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
ActionOn 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 Commerce36 units
DistributionWorldwide-The product was distributed to 28 U.S. consignees and 3 foreign consignees. (Canada, Switzerland, Japan)
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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