Recall Z-1070-2012 ยท KYX Dispenser, Liquid Medication
Benlan, Inc.
Children's Medical Ventures 1 ml Amber Oral Syringe. The product is a Liquid Medication Dispenser.
| Date | Feb 21, 2012 (initiated Dec 12, 2011) |
| Status | Terminated |
| Reason | The tip caps may come loose from the syringe, potentially resulting in leakage of medication from the syringe. |
| 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 | 143,250 |
| Distribution | Nationwide Distribution, USA - including only the state of Pennsylvania |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.