FDA Medical Device Recalls (openFDA)
Becton Dickinson & Company: 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
- Recall number
- Z-1555-2022
- Recalling firm
- Becton Dickinson & Company
- 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
- Status
- Open, Classified
- Initiated
- 2022-07-18
- Posted
- not on file
- Terminated
- not on file
- 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.
- 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 productcomplaints@bd.com General Follow-up, Product Complaints, Technical Questions
- Quantity
- 9,340 units
- Distribution
- US Nationwide Distribution CA FL GA IL MD MI OR PA PR TN TX
- Lot, serial or model codes
- UDI-DI: 30382905153045 Lot Numbers: 2007212, 2103205
- 510(k) numbers
- ["K123213"]
- PMA numbers
- not on file
- Product code
- ONB
- Firm FEI
- 2243072
- Firm city
- Franklin Lakes
- Firm state
- NJ
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28