Agency classClass IIOur severity:Severe FDA (Devices)·Z-2254-2017·Announced 2017-06-14

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 has a safety cover that 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, meeting the criteria for a Severe (Score 4) classification under the rubric.

Plain-English summary

Arrow International Inc. has initiated a recall of the ARROWg+ard Blue MAC Two-Lumen Central Venous Access Kit for use with 7.5 - 8 Fr. Catheters. The recall is driven by reports of safety cover disengagement and needlestick injuries associated with the BD Eclipse Needle that is packaged with certain Arrow products.

The affected devices are intended for venous access and catheter introduction to the central circulation via the jugular, subclavian, or femoral veins. The recall number is Z-2254-2017, and the agency classification is Class II. The source text indicates that 43,394 units were distributed nationwide.

Healthcare providers and facilities should stop using the affected kits and contact Arrow International for further instructions on how to handle the recalled products.

The recalled product

Product: ARROWg+ard Blue(R) MAC(TM) Two-Lumen Central Venous Access Kit for use with 7.5 - 8 Fr. Catheters 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…
Manufacturer: Arrow International Inc
Category: Medical Device — Central Venous Access
Hazard: needlestick-injury
mechanical-failure
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 # ASK-21142-HF3

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

See all →

High
Arrow Arterial Kits Recalled Due to Open Packaging Seals
FDA (Devices) · 2024-10-02
Severe
Intra-Aortic Balloon Catheter Kit Recalled for Inflation and Structural Defects
FDA (Devices) · 2024-06-12
Severe
Arrow UltraFlex Intra-Aortic Balloon Catheter Kit Recalled for Device Malfunction
FDA (Devices) · 2024-06-12
Severe
Arrow Ultra 8 Intra-Aortic Balloon Catheter Kit Recalled for Inflation Defect
FDA (Devices) · 2024-06-12
Severe
ARROW QuickFlash Radial Artery Catheters Recalled for Defective Component
FDA (Devices) · 2024-03-27

Same hazard · needlestick injury