Arrow VPS Access Kit Recalled for 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 reported needlestick injuries, which constitute significant injury reports, meeting the criteria for a Severe (4) rating.
Plain-English summary
Arrow International Inc. is recalling Arrow VPS Access Kits with Maximal Barrier Precautions for use with 4 Fr. Peripherally Inserted Central Venous Catheters. The recall was initiated due to reports of safety cover disengagement and needlestick injury associated with BD Eclipse Needles that are packaged with certain Arrow products.
The affected product is identified by material number ASK-04001-DU8. The firm reports that a total of 43,394 devices were distributed nationwide. The VPS System is intended to guide peripherally inserted central catheters (PICCs) to the cavo-atrial junction.
Healthcare facilities and users should stop using the affected kits and contact Arrow International for further instructions on return or replacement.
The recalled product
- Product
- Arrow¿ VPS¿ Access Kit with Maximal Barrier Precautions 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…
- Manufacturer
- Arrow International Inc
- Hazard
- 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-04001-DU8
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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