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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 Recall
Becton Dickinson and Company
see related information
Date Posted December 19, 2012
Recall Status1 Open
Recall Number Z-0564-2013
Recall Event ID 62394
Premarket Notification
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/
Manufacturer
Becton Dickinson & Company
1 Becton Dr
Franklin Lakes, New Jersey 07417-1815
Consumer Instructions Contact the recalling firm for information
For Additional Information Contact Mr. Greg Morgan
201-847-4344
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
COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Mix-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
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