ClearanceBrief
Recall Z-0564-2013 ยท FMF Syringe, Piston

Becton Dickinson & Company

Case Carton: BD Oral Dispensing Syringe 1 mL Clear with Tip Cap BD, Franklin Lakes, NJ 07417 USA Made in USA www.bd.com BD, Laagstraat 57, B-9140 Temse, Belgium On 100 unit plastic bag: BD oral syringes are intended to dispense oral medications.

DateDec 19, 2012 (initiated Oct 2, 2012)
StatusTerminated
ReasonBD received a complaint report for mixed syringe tips (oral and non-oral syringe tips) within the same lot.
Root causeMixed-up of materials/components
ActionBecton Dickinson sent a Urgent Product Recall letter/Customer Packing list dated October 2, 2012, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Customers were instructed to review inventory and determine if they have any of the affected product. If so, it should be removed from inventory. The enclosed customer list should be completed as well. Any questions please call 1-201-847-4267.
Quantity2,786,000 units
Distribution(USA) nationwide
FDA recordOpen on fda.gov

510(k) clearances named in this recall

K980987BECTON DICKINSON SYRINGE
Bd Becton Dickinson Vacutainer Systems Preanalytic, Jun 11, 1998