Fast-cath Trio Hemostasis Introducer recall
Fast-Cath Trio HEMOSTASIS INTRODUCER, 14F, 4.6 mm, REF 406303
Why was Fast-cath Trio Hemostasis Introducer recalled?
Fast-Cath Trio Hemostasis Introducer devices contained 12F sized dilators and sheaths instead of the expected 14F devices.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
UDI: (01)15414734203903(17)220731(10)7133555, Batch: 7133555
- Product
- Fast-Cath Trio HEMOSTASIS INTRODUCER, 14F, 4.6 mm, REF 406303
- Recalling firm
- Abbott Medical
- Quantity
- 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
- Recall date
- January 15, 2020
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)