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U.S. Department of Health and Human Services

Class 2 Device Recall BD

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  Class 2 Device Recall BD see related information
Date Initiated by Firm July 18, 2022
Create Date August 18, 2022
Recall Status1 Open3, Classified
Recall Number Z-1555-2022
Recall Event ID 90567
510(K)Number K123213  
Product Classification Closed antineoplastic and hazardous drug reconstitution and transfer system - Product Code ONB
Product BD PhaSealTM Y-Site Connector (C80)- airtight and leak-proof Closed System Drug Transfer Device (CSTD) that mechanically prohibits the transfer of environmental contaminants into the system and the escape of drug or vapor concentrations outside the system.
Catalog Number: 515304
Code Information UDI-DI: 30382905153045  Lot Numbers: 2007212, 2103205
Recalling Firm/
Manufacturer		 Becton Dickinson & Company
1 Becton Dr
Franklin Lakes NJ 07417-1815
For Additional Information Contact SAME
201-847-6800
Manufacturer Reason
for Recall		 Incorrect expiration date listed on the product labels. The expiration date listed on the product label is beyond the expiration date of the product.
FDA Determined
Cause 2		 Employee error
Action BD issued Urgent Medical Device Recall letter on 7/18/22 to Distributors and Customers. via email or mail. Letter states reason for recall, health risk and action to take: 1. Immediately review your inventory for the specific Catalog (Ref) and Lot numbers listed in table above and destroy following your institutions process for destruction. 2. Share this notification with all users within your facility network of the product to ensure they are also aware of this field action. This recall notice should also be shared with any organization where the potentially affected products have been transferred. 3. Complete the attached Customer Response Form and return form to the BD contact noted on the form whether or not you have any of the impacted material so that BD may acknowledge your receipt of this notification per FDA requirements and subsequently process your product replacement. BD Contact Contact Information Areas of Support North American Regional Complaint Center 1-844-8BD-LIFE (1-844-823-5433) Say Recall when prompted Mon Fri 8:00am and 5:00pm CT or productcomplaints@bd.com General Follow-up, Product Complaints, Technical Questions
Quantity in Commerce 9,340 units
Distribution US Nationwide Distribution CA FL GA IL MD MI OR PA PR TN TX
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 = ONB and Original Applicant = BECTON DICKINSON & CO.
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