Ethicon, Inc. 2024-06-26 Health serious FDA
Health · FDA · Recall #FDA-Z-2147-2024
PDS Plus Antibacterial (polydioxanone) Suture - Intended for use in general soft tissue… Recall
Issued June 26, 2024 · Ethicon, Inc.
In June 2024, Ethicon, Inc. recalled the PDS Plus Antibacterial (polydioxanone) Suture - Intended for use in general soft tissue…, a serious health recall reported by the FDA.
Compiled by Maya Ellison, RecallCheckr
What this means for you
Issue on a specific packaging machine resulted in a hole in the primary packaging, product sterility compromised and could result in infection .
What you should do
- 1 Stop using PDS Plus Antibacterial (polydioxanone) Suture - Intended for use in general soft tissue… right away.
- 2 Set it aside where it won't be used by mistake.
- 3 Contact Ethicon, Inc. 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
- Ethicon, Inc.
- Category
- Health
- Recall date
- June 26, 2024
- Units affected
- Not reported
- Sold at
- Worldwide distribution - US Nationwide including PR and the countries of AR, AU, AU, BE, BR, CA, CA, CL, CN, CO, CR, EC, IL, JP, JP, KW, MX,
- Recall number
- FDA-Z-2147-2024
- Made in
- United States
- Issuing agency
- FDA
In context
- Ethicon, Inc. has 1 recall in our database.
- We're tracking 3,576 Health recalls in our database.
- This is the 737th Health recall we've logged in 2024.