Arrow International Recalls Multi-Lumen Central Venous Catheterization Kits
Arrow International is recalling 416,055 Pressure Injectable Multi-Lumen Central Venous Catheterization Kits 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, creating a risk of infection. This fits the 'High' severity criterion for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Arrow International Inc is recalling 416,055 units of the Pressure Injectable Multi-Lumen Central Venous Catheterization Kit (Product Code: ASK-15703-PHMC). The recall is due to a defect where product sterility may be compromised by unsealed packaging.
The affected products are distributed in the United States and numerous international locations, including Australia, Canada, the United Kingdom, and various countries in Europe, Asia, and the Middle East. Specific lot numbers involved in this recall are 13F17A0285, 13F17C0381, 13F17D0214, 13F17E0356, 13F17F0736, and 13F17H0483.
Healthcare providers and facilities should check their inventory for these specific lot numbers and stop using the affected kits. Users should contact Arrow International Inc for further instructions on how to return or dispose of the recalled products.
The recalled product
- Product
- Pressure Injectable Multi-Lumen Central Venous Catheterization Kit; Product Code: ASK-15703-PHMC
- Manufacturer
- Arrow International Inc
- Category
- Medical Device — Catheter
- 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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