Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-1070-2012

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

Canadian Hospital Specialties Ltd. / initiated 2011-12-12 / Terminated / root cause: manufacturing process

Benlan, Inc. began a recall of Children's Medical Ventures 1 ml Amber Oral Syringe. The product is a Liquid Medication Dispenser on . The reason FDA records is "The tip caps may come loose from the syringe, potentially resulting in leakage of medication from the syringe". As of , the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number
Z-1070-2012
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Canadian Hospital Specialties Ltd.
Product
Children's Medical Ventures 1 ml Amber Oral Syringe. The product is a Liquid Medication Dispenser.
Product code
KYX Dispenser, Liquid Medication
Reason for recall
The tip caps may come loose from the syringe, potentially resulting in leakage of medication from the syringe.
Root cause tag
manufacturing process
FDA root cause
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
Product codes and lots
Catalog number 1047080 - lot numbers 076192, 076404, 076904, 077695, 078697, 079540 and 079686.