Fast-Cath Trio HEMOSTASIS INTRODUCER, 14F, 4.6 mm, REF 406303
Reported: January 15, 2020 Initiated: December 9, 2019 #Z-0783-2020
Product Description
Fast-Cath Trio HEMOSTASIS INTRODUCER, 14F, 4.6 mm, REF 406303
Reason for Recall
Fast-Cath Trio Hemostasis Introducer devices contained 12F sized dilators and sheaths instead of the expected 14F devices.
Details
- Recalling Firm
- Abbott Medical
- Units Affected
- 814 devices
- Distribution
- Worldwide Distributed - US Nationwide in sates of: FL, PA, NY, TX, MI CA, IL, NE, AL, NV, including PR and the countries of: Malaysia, Korea, Paraguay
- Location
- Plymouth, MN
Frequently Asked Questions
What product was recalled? ▼
Fast-Cath Trio HEMOSTASIS INTRODUCER, 14F, 4.6 mm, REF 406303. Recalled by Abbott Medical. Units affected: 814 devices.
Why was this product recalled? ▼
Fast-Cath Trio Hemostasis Introducer devices contained 12F sized dilators and sheaths instead of the expected 14F devices.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on January 15, 2020. Severity: Moderate. Recall number: Z-0783-2020.
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