Arrow Access Kit Recalled Due to Needlestick Injury Risk
Arrow International is recalling specific Access Kits because the packaged BD Eclipse Needle 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 is recalling the Arrow Access Kit for use with 4 Fr. Peripherally Inserted Central Venous Catheter. The recall is initiated due to reports of safety cover disengagement and needlestick injury associated with the BD Eclipse Needle that is packaged with certain Arrow products.
The affected product is identified by material number ASK-04001-DU4S1. The firm reports that a total of 43,394 devices were distributed nationwide. The Arrow GlideThru Peel-Away Sheath/Dilator Introducer is used for the percutaneous introduction of diagnostic or therapeutic devices into the vasculature.
Healthcare providers and facilities should stop using the affected Arrow Access Kits immediately. Users should contact Arrow International for instructions on returning the product or obtaining a replacement.
The recalled product
- Product
- Arrow(R) Access Kit for use with 4 Fr. Peripherally Inserted Central Venous Catheter The Arrow¿ GlideThru" Peel-Away Sheath/Dilator Introducer is used for the percutaneous introduction of diagnostic or therapuetic devices into the vasculature.
- Manufacturer
- Arrow International Inc
- Category
- Medical Device — Vascular Access
- 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-DU4S1
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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