Arrow International Recalls Central Venous Access Kits Due to Needlestick Risk
Arrow International is recalling 43,394 central venous access kits because the packaged BD Eclipse Needle has a safety cover that may disengage, posing a needlestick injury risk.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II and involves reports of needlestick injuries, which aligns with the rubric criterion for 'Severe' severity involving significant injury reports.
Plain-English summary
Arrow International Inc. is recalling 43,394 units of the ARROWg+ard Blue MAC Two-Lumen Central Venous Access 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 these specific Arrow products.
The affected product is identified by Material Number CDA-21242-1A. The MAC Two-Lumen Central Venous Access Device with ARROWg+ard Blue is designed to permit venous access and catheter introduction to the central circulation. The recall covers units distributed nationwide.
Healthcare facilities and consumers should stop using the affected kits and contact Arrow International Inc. for further instructions or replacement. The hazard involves the potential for needlestick injuries resulting from the failure of the safety cover on the packaged needle.
The recalled product
- Product
- ARROWg+ard Blue MAC Two-Lumen Central Venous Access Kit. The MAC Two-Lumen Central Venous Access Device with ARROWg+ard Blue permits venous access and catheter introduction to the central circulation
- Manufacturer
- Arrow International Inc
- 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 CDA-21242-1A
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.
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