BD PhaSealTM Y-Site Connector (C80)- airtight and leak-proof Closed System Drug Transfer Device (CSTD) that mechanically
Summary
The FDA issued a Class II for BD PhaSealTM Y-Site Connector (C80)- airtight and leak-proof Closed System Drug by Becton Dickinson & Company. 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..
Details
Source
Device Recall
External ID
Z-1555-2022
Action Date
2022-08-24
Status
Ongoing
Category
device
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
Lot/Code Info: UDI-DI: 30382905153045 Lot Numbers: 2007212, 2103205
Quantity Affected: 9,340 units
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.
Distribution
US Nationwide Distribution CA FL GA IL MD MI OR PA PR TN TX
Type: Voluntary: Firm initiated
Recall Initiated: 2022-07-18
Company
Franklin Lakes, NJ
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 132 device recalls issued in the same week, part of 413 device-related FDA actions this month.
Becton Dickinson & Company has 39 FDA actions in our database, including 39 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Becton Dickinson & Company) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Becton Dickinson & Company have FDA actions?
Becton Dickinson & Company has 39 FDA actions in our database, including 39 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1555-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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