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Terminated

Children's Medical Ventures 1 ml Amber Oral Syringe. The product is a Liquid Medication Dispenser.

FDA Recall Z-1070-2012 · Posted 2012-02-21

Recalling FirmBenlan, Inc.
Recall StatusTerminated
Product CodeKYX
Date Initiated2011-12-12
Date Terminated2013-03-19
Product Quantity143,250

Reason for Recall

The tip caps may come loose from the syringe, potentially resulting in leakage of medication from the syringe.

Firm 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.

Root Cause

Process control

Distribution Pattern

Nationwide Distribution, USA - including only the state of Pennsylvania

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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