Covidien Llc 2022-07-13 Health critical FDA
Health · FDA · Recall #FDA-Z-1312-2022
Palindrome Precision Chronic Catheter, Sterile, Single Use, Rx Only. For vascular access… Recall
Issued July 13, 2022 · Covidien Llc
In July 2022, Covidien Llc recalled the Palindrome Precision Chronic Catheter, Sterile, Single Use, Rx Only. For vascular access…, a critical health recall reported by the FDA. Affected owners are eligible for a voluntary. Here is what the hazard is and exactly what to do about it.
Compiled by Maya Ellison, RecallCheckr
What this means for you
There is a potential leaking condition within the hub of specific chronic dialysis catheters, due to an inter-lumen void in the hub component, which may result in unanticipated fluid return during use.
What you should do
- 1 Stop using Palindrome Precision Chronic Catheter, Sterile, Single Use, Rx Only. For vascular access… right away.
- 2 Set it aside where it won't be used by mistake.
- 3 Contact Covidien Llc 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
- Covidien Llc
- Category
- Health
- Recall date
- July 13, 2022
- Units affected
- Not reported
- Sold at
- Worldwide distribution - US Nationwide distribution in the states of AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA,
- Recall number
- FDA-Z-1312-2022
- Made in
- United States
- Issuing agency
- FDA
In context
- Covidien Llc has 1 recall 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.