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 Insight

This FDA Devices action (record #Z-1555-2022) was formally reported on August 24, 2022, with the manufacturer initiating the action on July 18, 2022. It is classified under Moderate severity (Class II), with a current status of Ongoing. Becton Dickinson & Company is listed as the recalling firm, operating out of Franklin Lakes, NJ. Federal records indicate 9,340 units units are affected.

The documented reason for this recall is: 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 data in the federal record shows the product reached: US Nationwide Distribution CA FL GA IL MD MI OR PA PR TN TX. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.

To put this record in context, PlainRecalls indexes 83,949 recalls across the FDA, CPSC, NHTSA and USDA FSIS going back to 1995. Within the same product category, the database holds 6 closely related recalls, of which 6 were also issued by FDA Devices. That clustering is a signal — repeated actions in a narrow category often indicate a systemic quality-control issue, a supplier-wide contamination, or a design defect that has propagated across product lines. This recall is roughly 4 years old; older recalls can remain relevant because many units enter resale, rental, and secondary-market channels where the original warning never reaches the end user. Always cross-check the recall number against the official agency page before relying on any summary.