Aquacel Ag Surgical SP Surgical Dressing Recalled for Out-of-Specification Thickness
ConvaTec is recalling Aquacel Ag Surgical SP dressings (Lot 5G00809) that were manufactured with greater-than-specified thickness. The dressing is used in surgical wound care.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is an FDA Class II recall with no reported illnesses or injuries. The hazard is a dimensional specification issue (thickness) that represents a quality defect but not an acute safety threat. Per the rubric, FDA Class II recalls without reported hospitalization or injury fall into the Moderate category.
Plain-English summary
ConvaTec, Inc is recalling Aquacel Ag Surgical SP surgical dressings, reference number 413556, measuring 9cm x 15cm (3.5 in. x 6 in.), due to manufacturing out of specification. Specifically, the affected dressing has greater thickness than specified.
The recall affects 4,230 units distributed nationwide across the following states: Maryland, Ohio, Illinois, North Carolina, Arizona, New York, Minnesota, Texas, Kansas, Tennessee, Indiana, Delaware, Michigan, Florida, Pennsylvania, California, Virginia, Mississippi, New Mexico, Georgia, and Colorado.
The affected product is identified by Lot/Batch number 5G00809. Healthcare providers and patients who have received or are using this product should contact ConvaTec for instructions on how to proceed. The FDA classified this as a Class II recall.
The recalled product
- Product
- Aquacel Ag Surgical SP REF: 413556 9cm x 15cm/3.5 in. x 6 in., Sterile R
- Manufacturer
- ConvaTec, Inc
- Hazard
- manufacturing-defect
- out-of-specification
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot/Batch: 5G00809
Distribution
Distributed nationwide across the United States.
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