Arrow International recalls Peel Away Sheath over Dilator due to packaging defect
Arrow International is recalling 416,055 units of Peel Away Sheath over Dilator because unsealed packaging may compromise product sterility.
What this means for you
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) even though no specific injuries or illnesses are reported in the source text.
Plain-English summary
Arrow International Inc is recalling 416,055 units of Peel Away Sheath over Dilator (Product Codes PL-05041 and PL-05052). The recall is being conducted because product sterility may be compromised due to unsealed packaging.
The affected products were distributed in the United States and internationally, including Australia, Austria, Belgium, Canada, and the United Kingdom. Specific lot numbers for Product Code PL-05041 include 13F17G0050, 13F17J0360, and 13F17K0376. Specific lot numbers for Product Code PL-05052 include 13F17C0435, 13F17E0720, 13F17G0077, and 13F17G0514.
Consumers and healthcare providers should stop using the affected products and contact Arrow International Inc for further instructions or a replacement.
The recalled product
- Product
- Peel Away Sheath over Dilator; Product Codes: PL-05041 and PL-05052
- Manufacturer
- Arrow International Inc
- 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.
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