Agency classClass IIOur severity:Severe FDA (Devices)·Z-2275-2017·Announced 2017-06-14

Arrow Central Venous Catheter Kits Recalled for Needlestick Injury Risk

Arrow International is recalling specific central venous catheter kits because the packaged BD Eclipse Needle safety cover 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 is classified as FDA Class II and involves reported needlestick injuries, which aligns with the rubric criteria for Severe severity involving significant injury reports.

Plain-English summary

Arrow International Inc. has initiated a recall of Pressure Injectable Two-Lumen Central Venous Catheterization Kits with Blue FlexTip and ARROWg+ard Blue PLUS Catheters. The recall is driven by reports that the safety cover on the BD Eclipse Needle, which is packaged with these specific Arrow products, may disengage. This disengagement creates a risk of needlestick injury for healthcare professionals handling the device.

The affected product is identified by material number ASK-42802-PST1. The recall is classified as Class II by the FDA, indicating a reasonable probability that the use of the product could cause temporary or medically reversible adverse health consequences. The product was distributed nationwide.

Healthcare facilities and users should stop using the affected kits and contact Arrow International for instructions on how to return or dispose of the product. The catheters are indicated for short-term central venous access, including multiple infusions, blood sampling, and pressure monitoring.

The recalled product

Product: Pressure Injectable Two-Lumen Central Venous Catheterization Kit with Blue FlexTip(R), ARROWg+ard Blue PLUS(R) Catheter The ARROWg+ard Blue Plus" antimicrobial catheter is indicated in the short-term ( < 30 days) treatment of diseases or conditions requiring central venous…
Manufacturer: Arrow International Inc
Category: Medical Device — Catheters
Hazard: needlestick-injury
mechanical-failure

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 ASK-42802-PST1

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