Recall Z-1070-2012

Benlan, Inc. · initiated December 12, 2011

Terminated

Product

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

Codes / lots: Catalog number 1047080 - lot numbers 076192, 076404, 076904, 077695, 078697, 079540 and 079686.

Reason for recall

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

FDA-determined cause: Process control

Action taken

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.

Details

Recall number
Z-1070-2012
Initiated
December 12, 2011
Posted by FDA
February 21, 2012
Terminated
March 19, 2013
Product code
KYX – Dispenser, Liquid Medication
Quantity
143,250
Distribution
Nationwide Distribution, USA - including only the state of Pennsylvania
Recalling firm
Benlan, Inc., Oakville

Official FDA recall record