ClearanceBrief
Recall Z-1097-2012 ยท KYX Dispenser, Liquid Medication

Becton Dickinson & Company

BD Oral Dispensing Syringe Oral Syringe Tip Caps various sizes ( 1 mL, 3 mL, 5 mL. 10 mL BD, Franklin Lakes, NJ 07417 USA Made in USA www.bd.com Ref Numbers 305207, 305218, 305210, 305220, 305208, 305218, 305219 Product Usage: Used for the oral administration of medications

DateFeb 23, 2012 (initiated Oct 5, 2011)
StatusTerminated
ReasonThere are complaint reports for loose tip caps in various types of oral syringes
Root causeDevice Design
ActionBecton Dickinson (BD) sent an Urgent: Product Recall letters dated October 5, 2011 to all affected consignees. The letter identifies the affected product, problem and actions to be taken. Customers are instructed to follow the instructions on how to handle the affected product: 1) Check their inventory to determine if they have any Oral Syringe Tip Caps from the impacted lot numbers. 2) If they have any of the impacted product return the Oral Syringe Tip Caps to BD for replacements as directed on the attached recall packing list. 3) If they use the Oral Syringe Tip Caps and require repla
Quantity22,827,500 units
Distribution(USA) Nationwide Distribution
FDA recordOpen on fda.gov

510(k) clearances named in this recall

This recall record lists no 510(k) number.