Fast-Cath Hemostasis Introducer recall
Fast-Cath Hemostasis Introducer, HEMOSTASIS INTRODUCER, 8.5F, 2.83 mm, REF 406143 - Product Usage: The Fast-Cath Hemostasis Introducers are indicated…
Why was Fast-Cath Hemostasis Introducer recalled?
Three lots of Fast-Cath Hemostasis Introducer devices contained 8F sized dilators and sheaths instead of the expected 8.5F 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?
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
- Product
- Fast-Cath Hemostasis Introducer, HEMOSTASIS INTRODUCER, 8.5F, 2.83 mm, REF 406143 - Product Usage: The Fast-Cath Hemostasis Introducers are indicated…
- Recalling firm
- Abbott Medical
- Quantity
- 380 devices
- Distribution
- Worldwide distribution - US Nationwide distribution in the states of MA, VA, NH, FL, CT, UT, OH, WI, NY, IA, MI, MS, PA, and countries of Canada, Czech Republic
- Recall date
- January 15, 2020
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)