BD PhaSeal recallZ-1555-2022 · Becton Dickinson & Company · initiated Jul 18, 2022
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Becton Dickinson & Company or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
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.
FDA root cause category: Employee error
What the company is doing
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
Recall details
- Recall number
- Z-1555-2022
- Status
- Open, Classified
- Initiated by the company
- Jul 18, 2022
- Recalling firm
- Becton Dickinson & Company
- Quantity
- 9,340 units
- Product code
- ONB
- FDA submissions
- K123213
- Distribution
- US Nationwide Distribution CA FL GA IL MD MI OR PA PR TN TX
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
Code information (models, lots, serial numbers)
UDI-DI: 30382905153045 Lot Numbers: 2007212, 2103205
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- BD PhaSeal 515304BD Switzerland Sàrl · Closed antineoplastic and hazardous drug reconstitution and transfer system2 recalls16 reports
Product lines
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
How recalls are matched to devices · Editorial policy · Report an error on this page