Arrow International Recalls CVC Kits Due to Needlestick Injury Risk
Arrow International is recalling specific CVC kits because the packaged BD Eclipse Needle may disengage, posing a needlestick injury risk to medical personnel.
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 aligns with the rubric criteria for significant injury reports.
Plain-English summary
Arrow International is recalling the AGB+ Pressure Injectable Multi-Lumen CVC Kit. 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 products are intended to permit venous access to the central circulation. The recall is limited to the specific material number CDA-42703-P1A. The products were distributed nationwide.
Healthcare facilities should stop using the affected kits and contact Arrow International for further instructions. The recall is classified as Class II by the FDA.
The recalled product
- Product
- AGB+ Pressure Injectable Multi-Lumen CVC Kit The Arrow Central Venous Catheters are intended to permit venous access to the central circulation by way of the femoral, jugular or subclavian veins.The ARROWg+ard Blue¿ Catheter permits venous access to the central circulation by…
- Manufacturer
- Arrow International Inc
- Hazard
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 CDA-42703-P1A
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.
See all 56 products in this recall →Related recalls
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Similar recalls
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