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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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
- Affected units
- 4,230
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
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