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Recall Observatory FDA recall evidence

Device 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

Z-1555-2022

July 18, 2022

Class II

Product summary

Firm
Becton Dickinson & Company
Event
Event 90567
Status
Ongoing
Classification
Class II
Quantity
9,340 units
Official record key
device-enforcement:Z-1555-2022

Official wording

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.

Code information: UDI-DI: 30382905153045 Lot Numbers: 2007212, 2103205

Distribution pattern: US Nationwide Distribution CA FL GA IL MD MI OR PA PR TN TX

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Incorrect expiration date listed on the product labels. The expiration date listed on the product label is beyond the expiration date of the product.