Arrow International Recalls Catheter Clamps Due to Sterility Risk
Arrow International Inc is recalling 7Fr. Catheter Clamps with Fastener 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 hazard involves a risk of harm (compromised sterility) where injury has not yet been reported, fitting the 'High' criteria. The FDA classification is Class II, which aligns with this severity level when no severe outcomes are confirmed.
Plain-English summary
Arrow International Inc is voluntarily recalling the 7Fr. Catheter Clamp with Fastener (Product Code: CC-00007). The recall affects a total of 416,055 units distributed across the United States and numerous international markets including Australia, Canada, France, Germany, Japan, and the United Kingdom.
The specific lots included in this recall are 13F17B0257, 13F17D0260, 13F17E0342, 13F17F0076, 13F17F0795, and 13F17J0271. The reason for the recall is that the product sterility may be compromised due to unsealed packaging.
The U.S. Food and Drug Administration has classified this recall as Class II. No illnesses or injuries have been reported in connection with this issue.
The recalled product
- Product
- 7Fr. Catheter Clamp with Fastener; Product Code: CC-00007
- 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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