Agency classClass IIOur severity:Severe FDA (Devices)·Z-1823-2012·Announced 2012-06-27

Arrow Recalls Central Venous Catheters Due to Potential Hub Voids

Arrow International is recalling 1,085 units of 7FR 3-Lumen Arrowg+ard Blue Plus Central Venous Catheters due to potential voids in the catheter hub that could cause interlumen crossover.

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 FDA classified this as a Class II recall. Per the rubric, an FDA Class II recall involving a medical device with a structural defect that could lead to significant injury or adverse health consequences is rated as Severe (4).

Plain-English summary

Arrow International, Inc. is recalling 1,085 units of the 7FR 3-Lumen Arrowg+ard Blue Plus(R) Pressure Injectable Central Venous Catheter (Catalog number CDC-42703-XP1A, Lot number RF2033361). The recall was initiated due to the possibility of voids in the catheter hub, which could lead to an interlumen crossover.

The affected products were distributed nationwide in the United States, specifically in the states of Alabama, Arizona, Arkansas, California, Colorado, Florida, Georgia, Illinois, Indiana, Kansas, Louisiana, Massachusetts, Michigan, Missouri, Nevada, New Hampshire, North Carolina, Ohio, Pennsylvania, Texas, Virginia, Washington, and Wisconsin.

Healthcare facilities and consumers should stop using the affected catheters and contact Arrow International for further instructions or a replacement. The FDA has classified this as a Class II recall.

The recalled product

Product: Arrow International, Inc. 7FR 3-Lumen Arrowg+ard Blue Plus(R) Pressure Injectable Central Venous Catheter - Catalog number CDC-42703-XP1A The multiple-lumen pressure injectable catheter permits venous access to central circulation and injection of contrast media. The…
Manufacturer: Arrow International Inc
Category: Medical Device — Catheter
Hazard: structural-defect
interlumen-crossover
Affected units: 1,085

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)

Lot number RF2033361

Distribution

Distributed nationwide across the United States.

The notice also names 23 states specifically:

Same manufacturer · Arrow International Inc

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