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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 Recall
Children's Medical Ventures 1 ml Amber Oral Syringe
see related information
Date Posted February 21, 2012
Recall Status1 Terminated 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
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
PRODUCTION CONTROLS: 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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
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