Arrow International Recalls Central Venous Catheter Kits Due to Sterility Risk
Arrow International Inc is recalling Pressure Injectable ARROWg+ard Blue PLUS(R) 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 is FDA Class II involving a risk-of-harm product (compromised sterility) where injury has not yet been reported. According to the rubric, this falls under High severity as it presents a significant health risk without confirmed illness reports.
Plain-English summary
Arrow International Inc has issued a recall for the Pressure Injectable ARROWg+ard Blue PLUS(R) Two-Lumen Central Venous Catheterization Kit, identified by Product Code ASK-42802-PWHC1. The company is recalling 416,055 total units distributed across the United States and numerous international markets including Australia, Canada, France, Germany, Japan, and the United Kingdom.
The recall was initiated because the product sterility may be compromised due to unsealed packaging. Affected products include those with lot numbers 13F17D0321, 13F17H0137, 13F17L0063, and 13F17L0555.
The U.S. Food and Drug Administration has classified this recall as Class II. No specific consumer actions are detailed in the provided source text beyond the identification of the hazard.
The recalled product
- Product
- Pressure Injectable ARROWg+ard Blue PLUS(R) Two-Lumen Central Venous Catheterization Kit; Product Code: ASK-42802-PWHC1
- Manufacturer
- Arrow International Inc
- 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: 13F17D0321 13F17H0137 13F17L0063 13F17L0555
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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