Arrow VPS Access Kit Recalled Due to Needlestick Injury Risk
Arrow International is recalling VPS Access Kits because packaged BD Eclipse Needles may disengage, posing a needlestick injury risk.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall involves a Class II medical device with reported needlestick injuries, which aligns with the rubric criterion for significant injury reports.
Plain-English summary
Arrow International is recalling the Arrow VPS Access Kit, which is used with 4 Fr. Peripherally Inserted Central Venous Catheters. The recall is initiated due to reports of safety cover disengagement and needlestick injury associated with the BD Eclipse Needle packaged with certain Arrow products.
The affected product is identified by material number ASK-04001-DU10 and was distributed nationwide. The VPS System is intended to guide peripherally inserted central catheters to the cavo-atrial junction.
Healthcare providers and consumers should stop using the affected Arrow VPS Access Kits and contact Arrow International for instructions on how to return the product or obtain a replacement.
The recalled product
- Product
- Arrow(R) VPS(R) Access Kit for use with 4 Fr. Peripherally Inserted Central Venous Catheter The intended use of the VPS Stylet and Console (VPS System) is to quickly and accurately guide market available peripherally inserted central catheters (PICCs) to the goal location which…
- Manufacturer
- Arrow International Inc
- Hazard
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-04001-DU10
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.
See all 56 products in this recall →Related recalls
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