Date Initiated by Firm | March 25, 2016 |
Create Date | June 09, 2016 |
Recall Status1 |
Terminated 3 on April 03, 2017 |
Recall Number | Z-1937-2016 |
Recall Event ID |
73828 |
510(K)Number | K110771 |
Product Classification |
Syringe, piston - Product Code FMF
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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 #) 309642, Lot #'s 4163814, 4252723, 4252726, 4252729, 4293878, 4340516, 5017729 and 5017735 |
Recalling Firm/ Manufacturer |
Becton Dickinson & Company 1 Becton Dr Franklin Lakes NJ 07417-1815
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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 | 811,200 units |
Distribution | Nationwide Distribution to NY only |
Total Product Life Cycle | TPLC Device Report |
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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.
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510(K) Database | 510(K)s with Product Code = FMF
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