The Recall Desk
HighFDA (Devices)·Z-1555-2022·Announced 2022-08-24

BD PhaSeal Y-Site Connector recalled for mislabeled expiration dates

Becton Dickinson recalls 9,340 units of BD PhaSeal Y-Site Connectors (Catalog 515304) due to incorrect expiration dates printed on product labels that extend beyond the actual product expiration.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This Class II medical device recall involves an incorrect expiration date on the product label. While no illnesses or injuries have been reported, the mislabeled expiration date creates a risk that users will employ the device beyond its actual safe life, potentially compromising the sterility and effectiveness of the CSTD.

Plain-English summary

Becton Dickinson & Company is recalling 9,340 units of the BD PhaSeal Y-Site Connector (C80), a Closed System Drug Transfer Device (Catalog Number 515304). The recalled product includes Lot Numbers 2007212 and 2103205.

The recall is due to incorrect expiration dates printed on the product labels. The expiration date shown on the label extends beyond the actual expiration date of the product, creating a risk that the device could be used after it has expired.

The affected devices have been distributed nationwide across the United States, including California, Florida, Georgia, Illinois, Maryland, Michigan, Oregon, Pennsylvania, Tennessee, and Texas, as well as Puerto Rico. Healthcare facilities and users should verify their inventory against the recalled lot numbers and ensure that affected devices are not used beyond their actual expiration date.

The recalled product

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: 51530
Manufacturer
Becton Dickinson & Company
Hazard
  • mislabeled-expiration-date

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

  • UDI-DI: 30382905153045 Lot Numbers: 2007212
  • 2103205

Distribution

Distributed nationwide across the United States.