Agency classClass IIOur severity:Severe FDA (Devices)·Z-2253-2017·Announced 2017-06-14

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.

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 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)…
Manufacturer: Arrow International Inc
Category: Medical Device — Central Venous Access
Hazard: needlestick-injury
safety-cover-disengagement
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.

See all 56 products in this recall →

Same manufacturer · Arrow International Inc

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Same hazard · needlestick injury