Arrow International Recalls 8Fr Catheter Clamps Due to Packaging Sterility Concerns
Arrow International Inc is recalling 8Fr Catheter Clamps with Fasteners 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, posing a risk of harm (infection) without reported 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 8Fr. Catheter Clamps with Fasteners (Product Code: CC-00008) due to a potential sterility issue. The recall was initiated because product sterility may be compromised due to unsealed packaging.
The affected products are identified by the following lot numbers: 13F17B0050, 13F17D0271, 13F17F0078, and 13F17J0276. A total of 416,055 units were distributed. The distribution pattern includes the US Nationwide and numerous international locations, including Australia, Austria, Belgium, Canada, and the United Kingdom.
Healthcare providers and facilities should check their inventory for these specific lot numbers and stop using the affected products. Consumers or patients who have received these devices should contact their healthcare provider for guidance on next steps.
The recalled product
- Product
- 8Fr. Catheter Clamp with Fastener; Product Code: CC-00008
- 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: 13F17B0050 13F17D0271 13F17F0078 13F17J0276
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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