Arrow Central Venous Catheter Kits Recalled for Packaging Sterility Concerns
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 is classified as FDA Class II and involves a medical device where sterility may be compromised, posing a risk of harm without reported injuries, which aligns with the 'High' severity criteria for risk-of-harm products.
Plain-English summary
Arrow International Inc is recalling 416,055 units of Pressure Injectable Multi-Lumen Central Venous Catheterization Kits with Blue FlexTip, ARROWg+ard Blue PLUS Catheter, and Sharps Safety Features. The recall involves product codes ASK-42703-PTJH and ASK-45703-PTJH. The agency classifies this as a Class II recall.
The recall is being conducted because product sterility may be compromised due to unsealed packaging. The affected products were distributed in the United States and numerous international locations, including Australia, Canada, and the United Kingdom.
Healthcare providers and consumers should stop using the affected products and contact Arrow International Inc for further instructions or a replacement.
The recalled product
- Product
- Pressure Injectable Multi-Lumen Central Venous Catheterization Kit with Blue FlexTip(R), ARROWg+ard Blue PLUS(R) Catheter and Sharps Safety Features; Product Codes: ASK-42703-PTJH and ASK-45703-PTJH
- 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
Same manufacturer · Arrow International Inc
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Same hazard · sterility compromise
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- HighMedline Recalls Cataract Convenience Kits Due to Open Sterile Seals
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- HighMedline Myringotomy Kits Recalled for Potential Sterility Compromise
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Similar recalls
- ModerateArrow Recalls Central Venous Catheter Kits Due to Sterility Concerns
FDA (Devices) · 2017-06-21
- ModerateArrow International Recalls Central Venous Catheter Kits Due to Packaging Seal Issues
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