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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 Posted December 19, 2012
Recall Status1 Terminated
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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = FMF and Original Applicant = BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC