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U.S. Department of Health and Human Services

Class 2 Device Recall Becton Dickinson and Company

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  Class 2 Device Recall Becton Dickinson and Company see related information
Date Initiated by Firm October 02, 2012
Date Posted December 19, 2012
Recall Status1 Open3, Classified
Recall Number Z-0564-2013
Recall Event ID 62394
510(K)Number K980987  
Product Classification Syringe, piston - Product Code FMF
Product 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.
Code Information Device Listing Number - R060456

REF Lot #, 305217 2076404, 305217 2055156, 305217 2020057, 305217 2020056, 305219 1346419.
Recalling Firm/
Becton Dickinson & Company
1 Becton Dr
Franklin Lakes NJ 07417-1815
For Additional Information Contact Mr. Greg Morgan
Manufacturer Reason
for Recall
BD received a complaint report for mixed syringe tips (oral and non-oral syringe tips) within the same lot.
FDA Determined
Cause 2
Mixed-up of materials/components
Action Becton 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.
Quantity in Commerce 2,786,000 units
Distribution (USA) nationwide
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = FMF and Original Applicant = BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC