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
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 harm (infection) even though no specific injuries or illnesses are reported in the source text.
Plain-English summary
Arrow International Inc is recalling 416,055 units of Double-Lumen Central Venous Catheterization Kits with Blue FlexTip(R), ARROWg+ard Blue PLUS(R) Catheter and Sharps Safety Features. The recall involves product codes ASK-42802-VC and ASK-47702-VC.
The recall was initiated because product sterility may be compromised due to unsealed packaging. This defect could potentially affect the safety of the medical devices.
The affected products were distributed in the United States and numerous international locations, including Australia, Canada, and the United Kingdom. Specific lot numbers for the ASK-42802-VC code are 13F17B0388, 13F17E0134, 13F17H0132, and 13F17K0152. Specific lot numbers for the ASK-47702-VC code are 13F17E0669, 13F17H0311, and 13F17L0076. Healthcare facilities and consumers should check their inventory for these specific product codes and lot numbers.
The recalled product
- Product
- Double-Lumen Central Venous Catheterization Kit with Blue FlexTip(R), ARROWg+ard Blue PLUS(R) Catheter and Sharps Safety Features; Product Codes: ASK-42802-VC and ASK-47702-VC
- 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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