Device product
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.
Z-0789-2020
Product summary
- Firm
- Abbott Medical
- Event
- Event 84459
- Status
- Terminated
- Classification
- Class II
- Quantity
- 380 devices
- Official record key
device-enforcement:Z-0789-2020
Official wording
Reason: Three lots of Fast-Cath Hemostasis Introducer devices contained 8F sized dilators and sheaths instead of the expected 8.5F devices.
Code information: Batch 6917183; UDI (01)15414734014219(17)220228(10)6917183 Batch 6950628; UDI (01)15414734014219(17)220331(10)6950628 Batch 7099144; UDI (01)15414734014219(17)220630(10)7099144
Distribution pattern: 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
Derived failure modes
-
Unknown
Three lots of Fast-Cath Hemostasis Introducer devices contained 8F sized dilators and sheaths instead of the expected 8.5F devices.