Arrow Maximal Barrier Drape Recalled for Unsealed Packaging
Arrow International Inc. is recalling 416,055 Maximal Barrier Drapes because unsealed packaging may compromise product 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 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, posing a risk of infection. Per the rubric, this is classified as High (3) because it is a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Arrow International Inc. is recalling 416,055 units of Maximal Barrier Drapes (Product Codes: ASK-00001-1A). The recall is due to a defect where unsealed packaging may compromise the sterility of the product.
The affected products were distributed in the United States and numerous international locations, including Australia, Canada, the United Kingdom, and various countries in Europe, Asia, and the Middle East. Specific lot numbers involved in this recall are 13F17E0104, 13F17F0318, 13F17G0569, 13F17J0423, and 13F17L0130.
Healthcare facilities and consumers should check their inventory for these specific product codes and lot numbers. If the packaging is unsealed, the product should not be used. Users should contact Arrow International Inc. for further instructions or to arrange for the return of the affected products.
The recalled product
- Product
- Maximal Barrier Drape; Product Codes: ASK-00001-1A
- Manufacturer
- Arrow International Inc
- Category
- Medical Device — Surgical Drapes
- Affected units
- 416,055
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 Numbers: 13F17E0104 13F17F0318 13F17G0569 13F17J0423 13F17L0130
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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