Z-0723-2023 Class II Ongoing
FDA device recall Z-0723-2023 was initiated by ConvaTec, Inc on Nov 15, 2022 and is designated Class II. Reason for recall: 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 dressing… The recall status is ongoing. Affected quantity: 5300 devices.
Recall Details
- Product Type
- Devices
- Report Date
- Dec 28, 2022
- Initiation Date
- Nov 15, 2022
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 5300 devices
Product Description
ConvaTec AQUACEL Foam Ag Adhesive, wound dressing advesive
Reason for Recall
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.
Distribution Pattern
US Nationwide distribution.
Code Information
REF number 420861, Batch 1C03858, exp 01 Mar 2023