Arrow International Recalls Central Venous Access Kits Due to Needlestick Risk
Arrow International is recalling specific Central Venous Access Kits because the packaged BD Eclipse Needle may disengage, posing a needlestick injury risk.
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 involves a risk-of-harm product (needlestick injury) where the specific hazard is explicitly named, fitting the High severity criteria for injury risks without confirmed fatalities or Class I classification.
Plain-English summary
Arrow International Inc. has initiated a recall of the ARROWg+ard Blue MAC Two-Lumen Central Venous Access Kit. The recall is 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 devices are identified by 510K # K011761 and material numbers CDA-21242-1A, CDA-29803-1A, and CDA-29903-1A. The firm reports that a total of 43,394 units were distributed nationwide. The MAC Multi-Lumen Central Venous Access Device is intended for venous access and catheter introduction to the central circulation via the jugular, subclavian, or femoral veins.
Healthcare providers and consumers should stop using the affected kits and contact Arrow International for further instructions on the recall process.
The recalled product
- Product
- ARROWg+ard Blue MAC Two-Lumen Central Venous Access Kit The MAC(TM) Multi-Lumen Central Venous Access Device with ARROWg+ard Blue(R) permits venous access and catheter introduction to the central circulation. It may be inserted into the jugular, subclavian, or femoral veins. The
- 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 (3)
- 510K # K011761 and Material numbers CDA-21242-1A
- CDA-29803-1A
- and CDA-29903-1A
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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