Recall Z-1795-2020 ยท GCB Needle, Catheter
Becton Dickinson & Company
CareFusion Safe-T-Centesis Catheter Drainage Tray, Sterile, For Single Use Only, Rx only, Catalog Number PIG1280T, UDI Number 01)10885403108402(17) 210930(10)0001304986
| Date | Mar 26, 2020 |
| Status | Terminated |
| Reason | The 8 Fr catheter was manufactured with the 6.9 Fr needle instead of the 8 Fr needle. |
| Root cause | Mixed-up of materials/components |
| Action | On March 26, 2020, an Urgent Medical Device Recall Notification was sent to consignees stating that Lot #0001304986 of the Safe-T-Centesis 8 Fr Catheter Drainage Trays shipped between June 27, 2019 and September 6, 2019 should be discarded. In addition, they were instructed to complete the Customer Response form regardless of whether or not they have any of the product. Customers with discarded product were instructed to indicate the number of affected products that were discarded on the response form and replacements would be issued to those customers. |
| Quantity | 900 |
| Distribution | Domestic distribution to the following states: Alabama, Colorado, Illinois, Massachusetts, Missouri, Oklahoma, Rhode Island, Virginia, and Wisconsin. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.