Arrow International Recalls Central Venous Catheter Kits Due to Packaging Issues
Arrow International is recalling 416,055 central venous catheterization kits because unsealed packaging may compromise product sterility.
What this means for you
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 hazard involves a packaging defect that may compromise sterility. As no specific injuries or illnesses are reported in the source text, it falls under the moderate category for potential risk without confirmed harm.
Plain-English summary
Arrow International Inc is recalling 416,055 units of Pressure Injectable Multi-Lumen Central Venous Catheterization Kits with Blue FlexTip, ARROWg+ard Blue PLUS Catheter, Sharps Safety Features and Maximal Barrier Precautions. The recall affects specific product codes ASK-45703-LDP1, ASK-45703-PBHS, and ASK-45703-PHMC, distributed in the United States and numerous international locations.
The recall was initiated because product sterility may be compromised due to unsealed packaging. This defect poses a risk of infection if the non-sterile product is used in a clinical setting.
Healthcare providers and consumers should stop using the affected products immediately. Users should check their inventory for the specific lot numbers listed in the recall notice and contact Arrow International Inc for instructions on returning the products.
The recalled product
- Product
- Pressure Injectable Multi-Lumen Central Venous Catheterization Kit with Blue FlexTip¿, ARROWg+ard Blue PLUS¿ Catheter, Sharps Safety Features and Maximal Barrier Precautions; Product Codes: ASK-45703-LDP1, ASK-45703-PBHS, ASK-45703-PHMC
- Manufacturer
- Arrow International Inc
- Category
- Medical Device — Catheters
- 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.
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