Arrow Central Venous Catheter Kit Recalled for Needlestick Injury Risk
Arrow International is recalling 43,394 units of ARROWg+ard Blue PLUS Two-Lumen Central Venous Catheterization Kits due to safety cover disengagement and needlestick injury reports.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II and involves a risk-of-harm product (needlestick injury) where the specific injury has been reported, fitting the 'High' severity criteria for risk-of-harm products.
Plain-English summary
Arrow International Inc. is recalling 43,394 units of the ARROWg+ard Blue PLUS(R) Two-Lumen Central Venous Catheterization Kit. 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-46702-AH and was distributed nationwide.
The Arrow(r) CVC is indicated to provide short-term central venous access for the treatment of diseases or conditions requiring such access, including multiple infusions of fluids, medications, or chemotherapy, and frequent blood sampling. The hazard involves the potential for needlestick injuries resulting from the disengagement of the safety cover on the packaged needle.
Healthcare facilities and consumers who have this product should stop using it and contact Arrow International Inc. for further instructions or a replacement. The recall is classified as Class II by the FDA, indicating a reasonable probability that the use of the product could cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- ARROWg+ard Blue PLUS(R) Two-Lumen Central Venous Catheterization Kit. 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 including, but not limited to: multiple infusions of
- Manufacturer
- Arrow International Inc
- Category
- Medical Device — Catheters
- 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-46702-AH
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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