Andover Healthcare Recalls Sterile Co-Flex Med Wound Dressings Due to Packaging Seal Defects
Andover Healthcare Inc. is recalling 1,050 cases of Sterile Co-Flex Med 4-inch wound dressings because of incomplete packaging seals that may compromise sterility.
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: The recall is classified as FDA Class II, but the source text does not report any illnesses, injuries, or hospitalizations. The hazard is a potential loss of sterility due to packaging defects, which fits the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Andover Healthcare Inc. is voluntarily recalling 1,050 cases of Sterile Co-Flex Med 4-inch single-use secondary wound dressings or compression wraps. The recall is due to incomplete packaging seals, which may compromise the sterile integrity of the product.
The affected products are identified by Catalog # 7400S, with expiration dates ranging from October 1, 2021, to June 14, 2022. Specific lot numbers involved in the recall are CI0X0D, CI18K8, and CI1DXN. The products were distributed nationwide in the United States, including Massachusetts, Texas, Rhode Island, Ohio, New York, Minnesota, South Dakota, Illinois, Missouri, Florida, Virginia, Nebraska, Utah, and California.
Consumers and healthcare facilities should stop using the affected products and contact Andover Healthcare Inc. for instructions on return or replacement. The FDA classifies this as a Class II recall, indicating a reasonable probability that the use of the product may cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- Sterile Co-Flex Med 4" - Product Usage: Single Use secondary wound dressing or compression wrap
- Manufacturer
- Andover Healthcare Inc.
- Category
- Medical Device — Wound Dressings
- Affected units
- 1,050
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 (2)
- CI18K8
- CI1DXN
Distribution
Part of a larger recall action
This product is one of 6 recalled by Andover Healthcare Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 6 products in this recall →Related recalls
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