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U.S. Department of Health and Human Services

Class 2 Device Recall BD Precision Glide Needle

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  Class 2 Device Recall BD Precision Glide Needle see related information
Date Initiated by Firm May 31, 2017
Create Date December 07, 2017
Recall Status1 Terminated 3 on June 28, 2018
Recall Number Z-0207-2018
Recall Event ID 77639
510(K)Number K021475  
Product Classification Needle, hypodermic, single lumen - Product Code FMI
Product BD Precision Glide Needle 18G x 1 RB, Catalog 305195

Product Usage:
These needles are intended for general purpose fluid injection/aspiration, infusion, venipuncture to obtain blood collection and insulin injection.
Code Information Lot Number: 6152995 Expiration Date: 31-Jul-21
Recalling Firm/
Manufacturer		 Becton Dickinson & Company
1 Becton Dr
Franklin Lakes NJ 07417-1815
For Additional Information Contact Leslie Robinson-Frye
201-847-6891
Manufacturer Reason
for Recall		 Hub damage resulting in breakage and/or leakage during use.
FDA Determined
Cause 2		 Process control
Action On May 31, 2017 BD distributed Urgent Medical Device Recall notices and Business Response Cards to their customers. Customers were advised to immediately review their inventory for the specific Catalog (Ref) and lot number, discontinue use of and quarantine the affected item. Complete and return the Business Response Card form via fax to BD 855-544-4803 or email the form to bd4354@stericycle.com. Return all affected products with the completed Business Response Card form following the instruction on the enclosed packing instruction. Upon receipt of the returned product, BD will issue product replacement. Note: If customers do not have any of the affected lots in your inventory, please complete the Business Response Card form indicating you have zero (0) quantity. Customers who have questions or require further assistance with the return of the recalled product, please contact 855-215-4932 between 8AM and 5PM, EST, Monday through Friday.
Quantity in Commerce 2,598,000 units
Distribution Nationwide Distribution
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 = FMI and Original Applicant = BD
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