Recall Z-1555-2022— Becton Dickinson & Company

Name: FDA recall Z-1555-2022
Creator: U.S. Food and Drug Administration
Published: 2022-07-18

Class II · Ongoing

Class II FDA medical device recall by Becton Dickinson & Company, initiated 2022-07-18. It names one FDA 510(k) clearance: K123213. 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. Reason: Incorrect expiration date listed on the product labels. The expiration date listed on the product label is beyond the expiration date of the product..

Recalling firm: Becton Dickinson & Company
Classification: Class II
Status: Ongoing
Initiated: 2022-07-18
Firm location: Franklin Lakes, NJ, United States

510(k) clearances named in this recall

1 on FDA's record

K123213 — BD PHASEAL CLOSED SYSTEM TRANSFER DEVICEBecton, Dickinson & CO·cleared 2013-01-09

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.