FDA Enforcement
Class II
Ongoing
ConvaTec AQUACEL Foam Ag Adhesive, wound dressing advesive
Recall: Z-0723-2023
·
Reported December 28, 2022
Enforcement
- Recall Number
- Z-0723-2023
- Event ID
- 91081
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- ConvaTec, Inc
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- December 28, 2022
- Initiation Date
- November 15, 2022
- Classification Date
- December 19, 2022
- Address
- 7815 National Service Rd Ste 600, Greensboro, NC, 27409-9403, United States
Description
ConvaTec AQUACEL Foam Ag Adhesive, wound dressing advesive
Reason
ConvaTec are voluntarily recalling a batch of AQUACEL¿ Foam Ag Adhesive 10cm x 10cm (x 10 pack) due to the identification of visual contamination in the form of brown spots present on several dressings.
Code Info
REF number 420861, Batch 1C03858, exp 01 Mar 2023
Distribution
US Nationwide distribution.
Quantity
5300 devices