Recall Z-0789-2020 ยท DYB Introducer, Catheter
Abbott Medical
Fast-Cath Hemostasis Introducer, HEMOSTASIS INTRODUCER, 8.5F, 2.83 mm, REF 406143 - Product Usage: The Fast-Cath Hemostasis Introducers are indicated for the introduction of angiographic catheters, closed-end catheters, balloon catheters, and electrodes into a vessel where minimizing blood loss is essential.
| Date | Dec 9, 2019 |
| Status | Terminated |
| Reason | Three lots of Fast-Cath Hemostasis Introducer devices contained 8F sized dilators and sheaths instead of the expected 8.5F devices. |
| Root cause | Packaging |
| Action | Beginning on December 9, 2019, US consignees will be notified in person by an Abbott field representative. OUS consignees will be notified by mail. The firm is seeking return of the devices. |
| Quantity | 380 devices |
| Distribution | Worldwide distribution - US Nationwide distribution in the states of MA, VA, NH, FL, CT, UT, OH, WI, NY, IA, MI, MS, PA, and countries of Canada, Czech Republic |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K914090 | DAIG FAST CATH(TM) INTRODUCER, MODIFICATION Daig Corp., Oct 28, 1991 |