Arrow International Recalls Two-Lumen CVC Kits Due to Foreign Material
Arrow International Inc is recalling 1,195 ARROWg+ard Blue PLUS Pressure Injectable Two-Lumen CVC Kits because visible foreign material was found inside the kits.
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 with a risk of harm from foreign material, but the source text does not report any injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Arrow International Inc is recalling 1,195 units of the ARROWg+ard Blue PLUS Pressure Injectable Two-Lumen CVC Kit. The recall is due to the discovery of foreign material within the kits. The foreign material consists of white or black particles and/or thread, which is visible and can be identified by the user.
The affected product is identified by product number CDC-42802-P1A and lot number 23F14A0063. The kits were distributed nationwide. The Multiple-Lumen Catheter is designed to permit venous access to the central circulation via the femoral, jugular, or subclavian veins.
Healthcare facilities and users should check their inventory for the specific product number and lot number listed above. If the product is found, it should be removed from use and returned to the manufacturer or disposed of according to local regulations.
The recalled product
- Product
- ARROWg+ard Blue PLUS Pressure Injectable Two-Lumen CVC Kit. The Multiple-Lumen Catheter permits venous access to the central circulation by way of the femoral jugular, or subclavian veins.
- Manufacturer
- Arrow International Inc
- Category
- Medical Device — Catheter
- Hazard
- Affected units
- 1,195
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 (2)
- product number CDC-42802-P1A
- lot number 23F14A0063
Distribution
Distributed nationwide across the United States.
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