Arrow Maximal Barrier Drape Recalled for Potential Sterility Compromise
Arrow International 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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device where sterility may be compromised, creating a risk of harm (infection) without reported injuries or illnesses, which aligns with the 'High' severity criteria for risk-of-harm products.
Plain-English summary
Arrow International Inc is recalling 416,055 units of Maximal Barrier Drape (Product Code: ASK-04000-HMC). The recall is being conducted because product sterility may be compromised due to unsealed packaging.
The affected lots are 13F17A0216, 13F17D0073, 13F17F0163, 13F17G0522, 13F17H0487, 13F17L0121, and 13F17L0651. These products were distributed nationwide in the United States and in 34 other countries, including Australia, Canada, the United Kingdom, and Germany.
Healthcare facilities and consumers should stop using these products and contact Arrow International Inc for further instructions or a refund.
The recalled product
- Product
- Maximal Barrier Drape; Product Code: ASK-04000-HMC
- 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.
See all 76 products in this recall →Related recalls
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