Reported Jan 15, 2020 · Terminated
Fast-Cath Trio HEMOSTASIS INTRODUCER, 14F, 4.6 mm, REF 406303
Abbott Medical
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Abbott Medical · 5050 Nathan Ln N · Plymouth, MN · 55442-3209
Is this the product you have?
Fast-Cath Trio HEMOSTASIS INTRODUCER14F4.6 mmREF 406303
- Lot codes and dates
- UDI(01)15414734203903(17)220731(10)7133555
- Batch7133555
- Amount recalled
- 814 devices
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
Why it was recalled
Fast-Cath Trio Hemostasis Introducer devices contained 12F sized dilators and sheaths instead of the expected 14F devices.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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