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.
|