Arrow International Recalls Central Venous Catheter Kits Due to Packaging Defect
Arrow International is recalling 416,055 Single-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 is compromised, posing a risk of harm (infection) even though no specific injuries or illnesses are reported in the source text. This aligns with 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(R) Catheter and Sharps Safety Features. The recall affects product code ASK-04301-TJ and specific lot numbers: 13F17E0674, 13F17G0265, 13F17J0087, 13F17K0099, and 13F17L0250.
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.
The affected products were distributed in the United States and numerous international locations, including Australia, Canada, the United Kingdom, and various countries in Europe, Asia, and the Americas. Healthcare facilities and distributors should check their inventory for the specific lot numbers listed and stop using the affected kits.
The recalled product
- Product
- Single-Lumen Central Venous Catheterization Kit with Blue FlexTip(R) Catheter and Sharps Safety Features; Product Codes: ASK-04301-TJ
- 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: 13F17E0674 13F17G0265 13F17J0087 13F17K0099 13F17L0250
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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