Arrow Maximal Barrier Drape Recalled for Incorrect Expiration Date Labeling
Arrow International Inc. is recalling Arrow Maximal Barrier Drapes because the product lidstock contains the incorrect expiration date.
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 and involves a labeling error (incorrect expiration date) without reported illnesses or injuries, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Arrow International Inc. is recalling Arrow Maximal Barrier Drapes (ASK-00002-1A) because the product lidstock contains the incorrect expiration date. The recall involves 2,080 units distributed nationwide and in foreign countries including AT, AU, DE, CA, CZ, GT, NZ, PL, SK, and ZA.
The affected lot numbers are 13F18G0481, 13F18H0652, and 13F18K0645. This recall is classified as Class II by the FDA. The source text does not report any illnesses or injuries associated with this recall.
The recalled product
- Product
- Arrow Maximal Barrier Drape ASK-00002-1A
- Manufacturer
- Arrow International Inc
- Category
- Medical Device — Surgical Drapes
- Hazard
- Affected units
- 2,080
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 Number: 13F18G0481 13F18H0652 13F18K0645
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 20 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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