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U.S. Department of Health and Human Services

Class 2 Device Recall SYRINGE 10ML E/T WITH US GRAPHICS

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  Class 2 Device Recall SYRINGE 10ML E/T WITH US GRAPHICS see related information
Date Initiated by Firm December 23, 2020
Create Date February 12, 2021
Recall Status1 Open3, Classified
Recall Number Z-1109-2021
Recall Event ID 87158
510(K)Number K980987  
Product Classification Syringe, piston - Product Code FMF
Product BD Hypodermic Syringe 10 ml, eccentric tip. Catalog (Ref No.) 305482
Code Information Catalog (Ref No.) 305482 100/package  UDI 00382903054824  Lot # 8142303  exp date 31-May-2023
Recalling Firm/
Manufacturer
Becton Dickinson & Company
1 Becton Dr
Franklin Lakes NJ 07417-1815
For Additional Information Contact Gail Griffiths
410-316-4054
Manufacturer Reason
for Recall
The product packaging for the 10 ml eccentric tip syringe may exhibit open seals. An open seal impacts package integrity and potentially compromises sterility of the syringe.
FDA Determined
Cause 2
Process control
Action On 01/13/2020 BD issued an Urgent Medical Device Recall notices to distributors via letters and via e-mail. Distributors are requested to identify their customers and provide BD a customer list so that BD can undertake further communication to the users. BD will distribute the recall communication to the distributors customers via FedEx upon receiving the customer information from the distributors. A copy of the BD product recall customer letter will be provided to distributors, in the case they opt to contact their customers directly.
Quantity in Commerce 155,200 needles
Distribution Distribution US nationwide and Canada
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
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