Arrow International Recalls Access Kits Due to Needlestick Injury Risk
Arrow International is recalling specific Access Kits because the packaged BD Eclipse Needle safety cover 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 constitutes a significant injury report under the severity rubric.
Plain-English summary
Arrow International has initiated a recall of the Arrow Access Kit with Maximal Barrier Precautions for use with 5 Fr. Peripherally Inserted Central Venous Catheter. The recall is due to reports that the safety cover on the BD Eclipse Needle, which is packaged with certain Arrow products, may disengage.
This disengagement creates a risk of needlestick injury. The affected product is identified by material number ASK-04001-DU5S. The firm reports that a total of 43,394 devices were distributed nationwide.
Healthcare providers and facilities should stop using the affected Arrow Access Kits and contact Arrow International for instructions on how to return or dispose of the products.
The recalled product
- Product
- Arrow¿ Access Kit with Maximal Barrier Precautions for use with 5 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
- 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-DU5S
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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