CLASS II Device recall · Reported 15 Jan 2020 · FDA Enforcement Report
Fast-Cath Hemostasis Introducer, Hemostasis Introducer, 8.5F recalled
Abbott Medical is recalling Fast-Cath Hemostasis Introducer, Hemostasis Introducer, 8.5F, distributed nationwide in the US. The recall was initiated on 9 Dec 2019 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0789-2020
- FDA event ID
- 84459
- Recalling firm
- Abbott Medical, Plymouth, MN
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 9 Dec 2019
- FDA classified
- 8 Jan 2020
- Reported
- 15 Jan 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Visit
- Reason category
- Other Reasons
- Device type
- Heart & Vascular Devices
Timeline
| 9 Dec 2019 | Recall initiated by company | |
| 8 Jan 2020 | Classified by FDA | +30 days |
| 15 Jan 2020 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Three lots of Fast-Cath Hemostasis Introducer devices contained 8F sized dilators and sheaths instead of the expected 8.5F devices.
Product as listed by the FDA
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.
Where it was distributed
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
Nationwide ConnecticutFloridaIowaMassachusettsMichiganMississippiNew HampshireNew YorkOhioPennsylvaniaUtahVirginiaWisconsin
Questions about this recall
Why was it recalled?
Three lots of Fast-Cath Hemostasis Introducer devices contained 8F sized dilators and sheaths instead of the expected 8.5F devices.
Which lots 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
Where was it sold?
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
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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