Recall Z-1555-2022 ยท ONB Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System
Becton Dickinson & Company
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
| Date | Jul 18, 2022 |
| Status | Open, Classified |
| 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. |
| Root cause | Employee error |
| Action | 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 trans |
| Quantity | 9,340 units |
| Distribution | US Nationwide Distribution CA FL GA IL MD MI OR PA PR TN TX |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K123213 | BD PHASEAL CLOSED SYSTEM TRANSFER DEVICE Becton, Dickinson & CO, Jan 9, 2013 |