Covidien LP 2024-02-07 Health serious FDA
Health · FDA · Recall #FDA-Z-0844-2024
Surgilon Braided Nylon sutures: 88861919-31 SURGILON* 4-0 BLK 7X75CMPCT 88861919-41… Recall
Issued February 7, 2024 · Covidien LP
In February 2024, Covidien LP recalled the Surgilon Braided Nylon sutures: 88861919-31 SURGILON* 4-0 BLK 7X75CMPCT 88861919-41…, a serious health recall reported by the FDA.
Compiled by Maya Ellison, RecallCheckr
What this means for you
Specific lots of sutures were sterilized with gamma doses that exceeded the range approved. The extra gamma levels may decrease the strength of the sutures over time, which could result in harms such as wound dehiscence and hemorrhage/blood loss/ bleeding at a critical level.
What you should do
- 1 Stop using Surgilon Braided Nylon sutures: 88861919-31 SURGILON* 4-0 BLK 7X75CMPCT 88861919-41… right away.
- 2 Set it aside where it won't be used by mistake.
- 3 Contact Covidien LP 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 LP
- Category
- Health
- Recall date
- February 7, 2024
- Units affected
- Not reported
- Sold at
- Worldwide US Nationwide distribution including in the states of AL, AZ, CA, FL, GA, HI, IA, IL, IN, MD, MI, MN, MO, MS, NC, NE, NJ, NV, NY
- Recall number
- FDA-Z-0844-2024
- Made in
- United States
- Issuing agency
- FDA
In context
- Covidien LP has 6 recalls in our database, including 4 rated Critical.
- We're tracking 3,576 Health recalls in our database.
- This is the 737th Health recall we've logged in 2024.