Arrow Maximal Barrier Drapes Recalled for Potential Sterility Compromise
Arrow International is recalling Maximal Barrier Drapes because unsealed packaging may compromise sterility. The recall covers 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 is classified as FDA Class II and involves a risk-of-harm product (sterile medical device) where injury has not yet been reported, fitting the 'High' severity criteria.
Plain-English summary
Arrow International Inc is recalling Maximal Barrier Drapes (Product Codes: ASK-00376-SU) due to a potential sterility issue. The recall is triggered by unsealed packaging, which may compromise the sterility of the medical devices.
The recall affects 416,055 total products, specifically Lot Numbers 13F17B0089 and 13F17L0152. 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 the affected drapes and contact Arrow International Inc for instructions on return or replacement. The FDA has classified this as a Class II recall, indicating a reasonable probability that use of the product could cause temporary or medically reversible health consequences.
The recalled product
- Product
- Maximal Barrier Drape; Product Codes: ASK-00376-SU
- 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: 13F17B0089 13F17L0152
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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