FDA Device recall Z-0789-2020
Fast-Cath Hemostasis Introducer, HEMOSTASIS INTRODUCER, 8.5F, 2.83 mm, REF 406143 - Product Usage: The Fast-Cath Hemostasis Introducers are…
- FDA Device
- Class II
- terminated
- Published 2020-01-15
On 2020-01-15 the FDA classified a Class II recall of Fast-Cath Hemostasis Introducer, HEMOSTASIS INTRODUCER, 8.5F, 2.83 mm, REF 406143 - Product Usage: The Fast-Cath Hemostasis Introducers are… by Abbott Medical, citing three lots of Fast-Cath Hemostasis Introducer devices contained 8F sized dilators and sheaths instead of the expected 8.5F devices.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0789-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2019-12-09 |
| Published | 2020-01-15 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Abbott Medical |
| Distribution | US |
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.
Reason
Three lots of Fast-Cath Hemostasis Introducer devices contained 8F sized dilators and sheaths instead of the expected 8.5F devices.
Identifiers
| code_info | Batch 6917183; UDI (01)15414734014219(17)220228(10)6917183 Batch 6950628; UDI (01)15414734014219(17)220331(10)6950628…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 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
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Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0789-2020%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.