Arrow Maximal Barrier Drape Recalled for Potential Sterility Compromise
Arrow International Inc is recalling Maximal Barrier Drapes because unsealed packaging may compromise product sterility. The recall affects 416,055 units distributed in the US and 34 other countries.
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. The hazard is a potential sterility compromise due to packaging issues, which is a theoretical risk without reported illnesses or injuries in the source text, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Arrow International Inc is recalling 416,055 units of Maximal Barrier Drapes (Product Code: ASK-00002-1A). The recall is being conducted because product sterility may be compromised due to unsealed packaging.
The affected products were distributed in the United States and 34 other countries, including Australia, Canada, the United Kingdom, and Germany. Specific lot numbers are listed in the recall documentation.
Healthcare facilities and consumers should stop using these products and contact Arrow International Inc for instructions on return or replacement. This recall is classified as Class II by the FDA, indicating a reasonable probability that the use of the product could cause temporary or medically reversible health consequences.
The recalled product
- Product
- Maximal Barrier Drape; Product Codes: ASK-00002-1A
- Manufacturer
- Arrow International Inc
- Category
- Medical Device — Surgical Drapes
- Affected units
- 416,055
Distribution
Part of a larger recall action
This product is one of 76 recalled by Arrow International 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.
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