Cook Incorporated 2024-10-16 Health serious FDA
Health · FDA · Recall #FDA-Z-0045-2025
Check-Flo Performer Introducer Set, Reference Part Number RCF-5.0-35-45-J, Order Number… Recall
Issued October 16, 2024 · Cook Incorporated
In October 2024, Cook Incorporated recalled the Check-Flo Performer Introducer Set, Reference Part Number RCF-5.0-35-45-J, Order Number…, a serious health recall reported by the FDA.
Compiled by Maya Ellison, RecallCheckr
What this means for you
Cook Medical is conducting removal of a lot of Check-Flo Performer Introducer Set due to complaints that the white caps that connect the shaft to the hub of these products may disconnect.
What you should do
- 1 Stop using Check-Flo Performer Introducer Set, Reference Part Number RCF-5.0-35-45-J, Order Number… right away.
- 2 Set it aside where it won't be used by mistake.
- 3 Contact Cook Incorporated to arrange your voluntary. See the official notice below for contact details.
- 4 Keep the product until your remedy is fully processed. You may need it.
Official remedy (Voluntary):
Recall details
- Brand
- Cook Incorporated
- Category
- Health
- Recall date
- October 16, 2024
- Units affected
- Not reported
- Sold at
- International distribution to the country of Australia.
- Recall number
- FDA-Z-0045-2025
- Made in
- United States
- Issuing agency
- FDA
In context
- Cook Incorporated has 12 recalls in our database, including 1 rated Critical.
- We're tracking 3,576 Health recalls in our database.
- This is the 737th Health recall we've logged in 2024.