Arrow International Recalls CVC Kits Due to Needlestick Injury Risk
Arrow International is recalling ARROWg+ard Blue Large-Bore Multi-Lumen CVC Kits because packaged BD Eclipse Needles 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 medical device with reported needlestick injuries, which constitutes a significant injury report under the severity rubric.
Plain-English summary
Arrow International Inc. has initiated a nationwide recall of ARROWg+ard Blue Large-Bore Multi-Lumen CVC Kits. The affected product is identified by Material Number CDA-25123-1A. This medical device is designed to permit venous access to the central circulation for rapid fluid administration and may be inserted into the jugular, subclavian, or femoral veins.
The recall was initiated due to reports of safety cover disengagement and needlestick injury associated with the BD Eclipse Needle packaged with certain Arrow products. The disengagement of the safety cover creates a risk of needlestick injuries for healthcare professionals handling the device.
Healthcare facilities and consumers should stop using the affected ARROWg+ard Blue Large-Bore Multi-Lumen CVC Kits immediately. Users should contact Arrow International Inc. for further instructions on how to return or dispose of the recalled product.
The recalled product
- Product
- ARROWg+ard Blue Large-Bore Multi-Lumen CVC Kit. The large-bore multiple-lumen catheter permits venous access to the central circulation for rapid fluid administration. It ma be inserted into the jugular, subclavian or femoral veins
- Manufacturer
- Arrow International Inc
- Category
- Medical Device — Catheter
- 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-25123-1A
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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