BEUDAMED
    FDA Recall Terminated

    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

    Recall: Z-1097-2012 · Initiated October 5, 2011

    Recall

    Recall Number
    Z-1097-2012
    Event Number
    61206
    Firm
    Becton Dickinson & Company
    FEI Number
    2243072
    Product Code
    KYX
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    October 5, 2011
    Posted
    February 23, 2012
    Terminated
    February 1, 2013
    Address
    1 Becton Dr, Franklin Lakes, NJ, 07417-1815

    Description

    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

    Reason

    There are complaint reports for loose tip caps in various types of oral syringes

    Action

    Becton 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 replacement, follow the instructions on the attached form. 4) If they have no inventory of the affected lots, indicate this on the website.

    Distribution

    (USA) Nationwide Distribution

    Quantity

    22,827,500 units