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U.S. Department of Health and Human Services

Class 2 Device Recall Henry Schein

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  Class 2 Device Recall Henry Schein see related information
Date Initiated by Firm March 25, 2016
Create Date June 09, 2016
Recall Status1 Terminated 3 on April 03, 2017
Recall Number Z-1936-2016
Recall Event ID 73828
510(K)Number K110771  
Product Classification Syringe, piston - Product Code FMF
Product Henry Schein Single Use Syringe Luer-Lock, 10 mL,
Intended for use by health care professionals for general purpose fluid aspiration/injection
Code Information Catalog (REF #) 9004476, Lot #4163707
Recalling Firm/
Manufacturer		 Becton Dickinson & Company
1 Becton Dr
Franklin Lakes NJ 07417-1815
For Additional Information Contact Ms. Zuleika Sanchez
201-847-5612
Manufacturer Reason
for Recall		 BD 10 mL Syringe Luer-Lok Tip with BD PrecisionGlide Needle 21G x 1 (0.8 mm x 25 mm) and Henry Schein 10 mL Single Use Syringe Luer-Lock are being recalled due to possible adulteration and non-conforming manufacturing practices.
FDA Determined
Cause 2		 Error in labeling
Action Becton Dickinson sent via email and UPS Ground an "Urgent Voluntary Product Recall" Letter dated March 25, 2016 along with a Recall Response Form and packaging instructions to their sole customer. Customers were instructed to immediately review their inventory , quarantine any affected product, and immediately discontinue shipment of the affected product. Customers should complete the Recall Response Card from and fax it to BD at 1-201-847-6990. Return all affected product with the completed Recall Response Card. If product was further distributed please identify your customers and notify them immediately of the product recall. Customers were also instructed to complete the Recall Response Form even if they do not have any affected lots in their inventory. Customers with questions were instructed to call 1-201-847-4267. For questions regarding this recall call 201-847-5612.
Quantity in Commerce 176,000 units
Distribution Nationwide Distribution to NY only
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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = FMF and Original Applicant = Becton, Dickinson and Company
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