Arrow International Recalls PICC Powered by VPS Stylet Kits
Arrow International is recalling 601 PICC powered by VPS Stylet kits because they may contain an incorrect catheter length.
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 component error that poses a risk of harm, but the source text does not report any injuries or illnesses, fitting the High severity criteria for risk-of-harm products without reported injury.
Plain-English summary
Arrow International Inc is recalling 601 units of ARROW PICC powered by ARROW VPS Stylet kits. The recall is due to a manufacturing error where kits intended to contain a 40cm catheter may instead contain a 55cm catheter.
The affected products were distributed in Arizona, California, Georgia, Massachusetts, Missouri, New York, and Virginia. The specific lot numbers involved are 23F17A0037 and 23F17B0035, with CDC code 34041 VPS.
Healthcare facilities and consumers should stop using these kits and contact Arrow International Inc for instructions on how to return the product.
The recalled product
- Product
- ARROW¿ PICC powered by ARROW¿ VPS¿ Stylet
- Manufacturer
- Arrow International Inc
- Category
- Medical Device — Catheters
- Hazard
- Affected units
- 601
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)
- CDC 34041 VPS Lot# 23F17A0037 23F17B0035
Distribution
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