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 infection. This fits the rubric for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Arrow International Inc is recalling 416,055 units of Single-Lumen Central Venous Catheterization Kits with Blue FlexTip ARROWg+ard Blue Catheter and Sharps Safety Features. The recall is being conducted because product sterility may be compromised due to unsealed packaging.
The affected products are identified by the following lot numbers: 13F17D0267, 13F17F0310, 13F17H0326, and 13F17K0315. The product code is ASK-24306-VC. These products were distributed in the United States and numerous international locations, including Australia, Canada, the United Kingdom, and various countries in Europe, Asia, and South America.
Healthcare providers and consumers should stop using the affected products and contact Arrow International Inc for further instructions or a return.
The recalled product
- Product
- Single-Lumen Central Venous Catheterization Kit with Blue FlexTip(R) ARROWg+ard Blue(R) Catheter and Sharps Safety Features; Product Code: ASK-24306-VC
- Manufacturer
- Arrow International Inc
- Category
- Medical Device — Catheters
- 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: 13F17D0267 13F17F0310 13F17H0326 13F17K0315
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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