Arrow International Extension Line Slide Clamps Recalled for Sterility Concerns
Arrow International is recalling Extension Line Slide Clamps because unsealed packaging may compromise product sterility. The recall affects 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 involves a medical device where sterility may be compromised, creating a risk of harm (infection) without reported injuries or illnesses, which aligns with the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Arrow International Inc is recalling Extension Line Slide Clamps (Product code: SA-09847) because product sterility may be compromised due to unsealed packaging. The recall involves 416,055 total products.
The affected products were distributed in the United States and 34 other countries, including Australia, Canada, the United Kingdom, and Germany. Specific lot numbers involved in the recall are 13F17A0109, 13F17D0071, 13F17E0795, 13F17F0743, 13F17H0099, and 13F17K0227.
Healthcare providers and consumers should stop using the affected products and contact Arrow International Inc for further instructions or a return.
The recalled product
- Product
- Extension Line Slide Clamps; Product codes: SA-09847
- 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.
See all 76 products in this recall →Related recalls
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