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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 GRAPHICSsee related information
Date Initiated by FirmDecember 23, 2020
Create DateFebruary 12, 2021
Recall Status1 Terminated 3 on November 21, 2022
Recall NumberZ-1109-2021
Recall Event ID 87158
510(K)NumberK980987 
Product Classification Syringe, piston - Product Code FMF
ProductBD 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 ContactGail 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
ActionOn 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 Commerce155,200 needles
DistributionDistribution US nationwide and Canada
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = FMF
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