Arrow International Recalls Maximal Barrier Drapes Due to Packaging Defect
Arrow International is recalling 416,055 Maximal Barrier Drapes because unsealed packaging may compromise product sterility. The recall covers lots 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 infection. This fits the rubric for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Arrow International Inc is recalling 416,055 units of Maximal Barrier Drape (Product Code: ASK-01000-UPMS). The recall is due to a defect where product sterility may be compromised by unsealed packaging.
The affected lots are 13F17A0280, 13F17H0434, and 13F17L0480. These products were distributed nationwide in the United States and in 34 other countries, including Australia, Canada, and the United Kingdom.
Healthcare facilities and consumers should check their inventory for these specific lot numbers. If the product is found, it should be removed from use and returned to the distributor or manufacturer in accordance with recall instructions.
The recalled product
- Product
- Maximal Barrier Drape; Product Code: ASK-01000-UPMS
- 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: 13F17A0280 13F17H0434 13F17L0480
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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