Cook Incorporated 2022-10-05 Health serious FDA
Health · FDA · Recall #FDA-Z-1836-2022
Newton Wire Guide (LT Taper/10cm Distal Flexibility), Guidewire Reference Part… Recall
Issued October 5, 2022 · Cook Incorporated
In October 2022, Cook Incorporated recalled the Newton Wire Guide (LT Taper/10cm Distal Flexibility), Guidewire Reference Part…, a serious health recall reported by the FDA.
Compiled by Maya Ellison, RecallCheckr
What this means for you
Cook Medical identified that devices from the affected device lots may have a complete breach of the chevron seal of the packaging. Therefore, the sterility of affected devices may be compromised.
What you should do
- 1 Stop using Newton Wire Guide (LT Taper/10cm Distal Flexibility), Guidewire Reference Part… 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 5, 2022
- Units affected
- Not reported
- Sold at
- Domestic distribution nationwide. Foreign distribution worldwide.
- Recall number
- FDA-Z-1836-2022
- 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 870th Health recall we've logged in 2022.