Arrow International Recalls Catheter Clamps Due to Sterility Risk
Arrow International Inc is recalling 4Fr. Catheter Clamps with Fastener 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 is FDA Class II involving a medical device with compromised sterility due to unsealed packaging. This presents a risk of harm (infection) where injury has not yet been reported, fitting the 'High' severity criteria.
Plain-English summary
Arrow International Inc has initiated a recall of the 4Fr. Catheter Clamp with Fastener, identified by Product Code CC-00004. The company is recalling approximately 416,055 units distributed nationwide in the United States and internationally to countries including Australia, Canada, France, Germany, Japan, the United Kingdom, and others.
The recall was triggered because the product's packaging may be unsealed, which compromises the sterility of the medical device. Affected items include specific lot numbers: 13F17A0199, 13F17C0048, 13F17D0270, 13F17F0258, and 13F17G0529.
The U.S. Food and Drug Administration (FDA) has classified this recall as Class II. Consumers or healthcare providers who possess these products should contact the firm for further instructions regarding return or replacement.
The recalled product
- Product
- 4Fr. Catheter Clamp with Fastener; Product Code: CC-00004
- Manufacturer
- Arrow International Inc
- 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: 13F17A0199 13F17C0048 13F17D0270 13F17F0258 13F17G0529
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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