Arrow International Recalls Two-Lumen Hemodialysis Catheterization Kits
Arrow International Inc is recalling specific lots of two-lumen hemodialysis catheterization kits due to a Class II medical device recall.
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. The source text does not report specific injuries, illnesses, or hospitalizations, but identifies a risk of harm related to infection protection efficacy, fitting the 'High' criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Arrow International Inc is recalling the Two-Lumen Hemodialysis Catheterization Kit with Blue FlexTip, ARROWg+ard Blue Catheter, Sharps Safety Features and Maximal Barrier Precautions for High Volume Infusions. The recall involves material number ASK-22122-MM. The firm reports that a total of 43,394 devices were distributed nationwide.
The recall is classified as Class II by the U.S. Food and Drug Administration. The source text describes the catheter as providing protection against catheter-related infections but notes that clinical data have not been collected to demonstrate that the antimicrobial surface decreases infections in hemodialysis patients. The catheter is not intended to treat existing infections or for long-term use.
Healthcare providers and patients should stop using the affected devices and contact Arrow International Inc for further instructions.
The recalled product
- Product
- Two-Lumen Hemodialysis Catheterization Kit with Blue FlexTip(R), ARROWg+ard Blue(R) Catheter, Sharps Safety Features and Maximal Barrier Precautions for High Volume Infusions The Arrow(r) CVC is indicated to provide short-term ( < 30 days) central venous access for treatment of…
- Manufacturer
- Arrow International Inc
- Category
- Medical Device — Catheters
- Affected units
- 43,394
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)
- Material number ASK-22122-MM
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 56 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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