Arrow International Recalls Two-Lumen Central Venous Catheterization Kits
Arrow International is recalling 416,055 Two-Lumen Central Venous Catheterization Kits because unsealed packaging may compromise product sterility.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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, creating a risk of harm (infection) even though specific injuries or illnesses are not reported in the source text.
Plain-English summary
Arrow International Inc is recalling 416,055 units of the Two-Lumen Central Venous Catheterization Kit with Blue FlexTip(R) Catheter and Sharps Safety Features (Product Code: ASK-15402-HOP). The recall affects Lot Numbers 13F17C0183 and 13F17F0775.
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 internationally, including Australia, Austria, Belgium, Canada, and numerous other countries. Healthcare facilities and distributors should stop using the affected lots and contact Arrow International for further instructions.
The recalled product
- Product
- Two-Lumen Central Venous Catheterization Kit with Blue FlexTip(R) Catheter and Sharps Safety Features; Product Code: ASK-15402-HOP
- 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: 13F17C0183 13F17F0775
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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