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
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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
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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 |
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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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