Z-1555-2022Class II

BD PhaSealTM Y-Site Connector (C80)- airtight and leak-proof Closed System Drug Transfer Device (CSTD) that...

Name: Z-1555-2022 BD PhaSealTM Y-Site Connector (C80)- airtight and leak-proof Closed System Drug Transfer Device (CSTD) that...
Creator: Becton Dickinson & Company
Published: 2022-07-18
License: https://open.fda.gov/license/

Becton Dickinson & Co / initiated 2022-07-18 / Open, Classified / root cause: manufacturing process

FDA source

Becton Dickinson & Company began a recall of BD PhaSealTM Y-Site Connector (C80)- airtight and leak-proof Closed System Drug Transfer Device (CSTD) that mechanically prohibits the transfer of... on 2022-07-18. FDA classified it as Class II and gives the reason as "Incorrect expiration date listed on the product labels. The expiration date listed on the product label is beyond the expiration date of the product". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1555-2022
Classification: Class II
Status: Open, Classified
Initiated: 2022-07-18
Posted: 2022-08-18
Recalling firm: Becton Dickinson & Co
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
Product code: ONB Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System
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.
Root cause tag: manufacturing process
FDA root cause: 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 [email protected] 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
Product codes and lots: UDI-DI: 30382905153045 Lot Numbers: 2007212, 2103205

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1555-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1555-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-08-24	2022-08-18

Product code ONB

K123213Class IIBd Phaseal Closed System Transfer DeviceBecton, Dickinson & CO / cleared 2013-01-09

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)