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U.S. Department of Health and Human Services

Class 3 Device Recall Children's Medical Ventures 1 ml Amber Oral Syringe

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  Class 3 Device Recall Children's Medical Ventures 1 ml Amber Oral Syringe see related information
Date Initiated by Firm December 12, 2011
Date Posted February 21, 2012
Recall Status1 Terminated 3 on March 19, 2013
Recall Number Z-1070-2012
Recall Event ID 60828
Product Classification Dispenser, liquid medication - Product Code KYX
Product Children's Medical Ventures 1 ml Amber Oral Syringe. The product is a Liquid Medication Dispenser.
Code Information Catalog number 1047080 - lot numbers 076192, 076404, 076904, 077695, 078697, 079540 and 079686.
Recalling Firm/
Manufacturer		 Benlan, Inc.
2760 Brighton Road
Oakville Canada
For Additional Information Contact Cheryl Brown
905-829-5007 Ext. 233
Manufacturer Reason
for Recall		 The tip caps may come loose from the syringe, potentially resulting in leakage of medication from the syringe.
FDA Determined
Cause 2		 Process control
Action The firm initiated their recall of the specified lots of product in November, 2011 by sending a "Customer/Distributor Medical Device Correction" letter to their consignee. The letter requested they examine their inventory, quarantine any affected product and complete a verification and response form to be returned to the firm. Questions were directed to (905) 829-5004 ext 233.
Quantity in Commerce 143,250
Distribution Nationwide Distribution, USA - including only the state of Pennsylvania
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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