Arrow International Recalls Central Venous Access Kits Due to Needlestick Risk
Arrow International is recalling MAC Two-Lumen Central Venous Access Kits because packaged BD Eclipse Needles 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 involves reported needlestick injuries, which constitute significant injury reports under the severity rubric for medical devices.
Plain-English summary
Arrow International Inc. is recalling the MAC Two-Lumen Central Venous Access Kit with ARROWg+ard Blue Access Device. 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 devices are intended for venous access and catheter introduction to the central circulation. The recall covers units distributed nationwide. The source text does not specify the exact number of units recalled, though firm reports indicate a total of 43,394 devices were distributed.
Healthcare facilities and users should stop using the affected kits and contact Arrow International for instructions on returning the products. This recall addresses a specific safety defect in the packaged needle component rather than the central venous access device itself.
The recalled product
- Product
- MAC(TM) Two-Lumen Central Venous Access Kit with ARROWg+ard Blue(R) Access Device, Integral Hemostasis Valve, Sharps Safety Features and Maximal Barrier Precautions for use with 7.5 - 8 Fr. Catheters The MAC(TM) Multi-Lumen Central Venous Access Device with ARROWg+ard Blue(R) pe
- 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 (2)
- 510K # K002507
- Material number: ASK-21142-HF2
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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