Arrow International Recalls Central Venous Catheter Kits Due to Packaging Defect
Arrow International is recalling 416,055 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 may be compromised, creating a risk of harm (infection) even though no specific injuries are reported in the source text, fitting the 'High' severity criteria for risk-of-harm products.
Plain-English summary
Arrow International Inc is recalling 416,055 units of 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-SCH, ASK-45703-UAB, and ASK-45703-VAH, 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 facilities and distributors should stop using the affected products and contact Arrow International for instructions on return or replacement. Consumers should not use these medical devices if they have them in their possession.
The recalled product
- Product
- Multi-Lumen Central Venous Catheterization Kit with Blue FlexTip(R), ARROWg+ard Blue PLUS(R) Catheter, Sharps Safety Features, and Maximal Barrier Precautions; Product Codes: ASK-45703-SCH; ASK-45703-UAB, ASK-45703-VAH
- 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.
See all 76 products in this recall →Related recalls
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Similar recalls
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