ConvaTec, Inc 2022-06-01 Health serious FDA
Health · FDA · Recall #FDA-Z-1134-2022
SUR-FIT Natura S4S Durahesive Wafer 70MM (1X10PK) US. Each market unit contains 10… Recall
Issued June 1, 2022 · ConvaTec, Inc
In June 2022, ConvaTec, Inc recalled the SUR-FIT Natura S4S Durahesive Wafer 70MM (1X10PK) US. Each market unit contains 10…, a serious health recall reported by the FDA.
Compiled by Maya Ellison, RecallCheckr
What this means for you
Firm received 10 complaints of skin barrier delamination issues (e.g. flange lifts from wafer, skin barrier layers separate) or tape border rips/tears.
What you should do
- 1 Stop using SUR-FIT Natura S4S Durahesive Wafer 70MM (1X10PK) US. Each market unit contains 10… right away.
- 2 Set it aside where it won't be used by mistake.
- 3 Contact ConvaTec, 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
- ConvaTec, Inc
- Category
- Health
- Recall date
- June 1, 2022
- Units affected
- Not reported
- Sold at
- Distributed nationwide to NJ, PA, OH, CA, AL, MI, NY, TX, FL, NC, VA, LA, IL, DE, KY, WA, KS, MN, MS and internationally to India.
- Recall number
- FDA-Z-1134-2022
- Made in
- United States
- Issuing agency
- FDA
In context
- ConvaTec, Inc has 2 recalls in our database.
- We're tracking 3,576 Health recalls in our database.
- This is the 870th Health recall we've logged in 2022.