—#194790

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

FDA product code: ONB — Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System
Device class: Class 2
Medical specialty: General Hospital
510(k) numbers: K123213
Affected lot / code info: UDI-DI: 30382905153045 Lot Numbers: 2007212, 2103205

Why it was recalled

Incorrect expiration date listed on the product labels. The expiration date listed on the product label is beyond the expiration date of the product.

Root cause (FDA determination)

Employee error

Action the firm took

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

Recalling firm

Firm: Becton Dickinson & Company
Address: 1 Becton Dr, Franklin Lakes, New Jersey 07417-1815

Distribution

Distribution pattern: US Nationwide Distribution CA FL GA IL MD MI OR PA PR TN TX

Timeline

Recall initiated: 2022-07-18
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #194790. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.