Arrow VPS Access Kit Recalled for Needlestick Injury Risk
Arrow International is recalling VPS Access Kits due to safety cover disengagement on packaged BD Eclipse Needles, 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 (Score 4) classification.
Plain-English summary
Arrow International Inc. is recalling 43,394 units of the Arrow VPS Access Kit with Maximal Barrier Precautions for use with 5 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 packaged with these specific Arrow products.
The affected product is identified by Material Number ASK-04001-DU7. The Arrow CVC is indicated for short-term central venous access, including for infusions of fluids, medications, or chemotherapy, and frequent blood sampling. The recall covers units distributed nationwide.
Healthcare facilities and consumers should stop using the affected Arrow VPS Access Kits immediately. Users should contact Arrow International Inc. for further instructions on how to return or dispose of the recalled products.
The recalled product
- Product
- Arrow VPS Access Kit with Maximal Barrier Precautions for use with 5 Fr. Peripherally inserted Central Venous Catheter The Arrow(r) CVC is indicated to provide short-term (<30 days) central venous access for treatment of diseases or conditions requiring central venous access…
- Manufacturer
- Arrow International Inc
- Category
- Medical Device — Catheter
- 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-DU7
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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