Arrow International Recalls Clear Fenestrated Drapes Due to Packaging Issues
Arrow International Inc is recalling 416,055 Clear Fenestrated Drapes with Adhesive 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 is compromised, posing a risk of harm (infection) even though no specific injuries are reported in the source text, fitting the 'High' severity criteria for risk-of-harm products.
Plain-English summary
Arrow International Inc is recalling 416,055 units of Clear Fenestrated Drape with Adhesive (Product Code: CD-00001). The recall involves specific lot numbers 13F17G0258 and 13F17J0281. The products were distributed in the United States and numerous international locations, including Australia, Canada, and the United Kingdom.
The recall was initiated because product sterility may be compromised due to unsealed packaging. This defect poses a risk of infection if the non-sterile product is used in a clinical setting where sterility is required.
Healthcare facilities and consumers should stop using the affected products immediately. Users should check their inventory for the specific product code and lot numbers listed above. If the products are found, they should be returned to the supplier or disposed of according to local regulations.
The recalled product
- Product
- Clear Fenestrated Drape with Adhesive; Product Code: CD-00001
- 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: 13F17G0258 13F17J0281
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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