Recall Z-0789-2020— Abbott Medical
Class II · Terminated
Class II FDA medical device recall by Abbott Medical, initiated 2019-12-09, terminated 2020-12-11. It names one FDA 510(k) clearance: K914090. 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..
- Recalling firm
- Abbott Medical
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2019-12-09
- Terminated
- 2020-12-11
- Firm location
- Plymouth, MN, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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 for recall
Three lots of Fast-Cath Hemostasis Introducer devices contained 8F sized dilators and sheaths instead of the expected 8.5F devices.
Data sourced from openFDA. This site is unofficial and independent of the FDA.