Arrow International Recalls 5Fr Catheter Clamps Due to Sterility Concerns
Arrow International is recalling 5Fr Catheter Clamps with Fasteners 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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the source text describes a theoretical risk of compromised sterility without reporting any specific illnesses or injuries, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Arrow International Inc is recalling 5Fr Catheter Clamps with Fasteners (Product Code: CC-00005) due to a potential sterility issue. The recall is being conducted because the product packaging may be unsealed, which could compromise the sterility of the medical device.
A total of 416,055 units are affected by this recall. The products were distributed nationwide in the United States and in numerous international locations, including Australia, Canada, the United Kingdom, and various countries in Europe, Asia, and South America. Specific lot numbers involved in the recall include 13F17A0198, 13F17C0056, 13F17D0135, 13F17D0236, 13F17F0075, 13F17F0600, 13F17G0179, 13F17H0107, 13F17H0367, 13F17J0198, and 13F17K0212.
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 manufacturer or disposed of according to local regulations. This action is taken to prevent the use of potentially non-sterile medical devices.
The recalled product
- Product
- 5Fr. Catheter Clamp with Fastener; Product Code: CC-00005
- 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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