NeoPICC recall

Specialties NICU

Published

http://www.arrowintl.com/about/investor/120304.asp

For Immediate Release

Date: December 3, 2004 Media Contact:

Frederick J. Hirt, 610-478-3117

ARROW INTERNATIONAL ISSUES NATIONWIDE VOLUNTARY RECALL OF

NeoPICC® 1.9 FR PERIPHERALLY INSERTED CENTRAL CATHETER

READING, PA, December 3, 2004 - Arrow International, Inc., today announced that after consulting with the FDA, the Company is voluntarily initiating a nationwide recall of all of the NeoPICC® 1.9 FR Peripherally Inserted Central Catheters (Product Numbers S1PIC19-N; S1PIC19-S; S1PIC19-SMK; and S1PIC19-C).

Arrow International is reviewing reports and investigating the root cause of several adverse events during which the NeoPICC® 1.9 FR Peripherally Inserted Central Catheter was utilized. These events, including one death, have been reported to involve possible vessel erosion.

Medical professionals who have NeoPICC® 1.9 FR Peripherally Inserted Central Catheters are advised to cease using the device. The devices can be identified by their product number.

NeoPICC® 1.9 FR Peripherally Inserted Central Catheters are distributed nationwide through the Company's distributors and to hospitals. Arrow distributes approximately 65,000 units of these products annually.

On November 23, 2004, Arrow International issued a Field Notification to its distributors and customers and is arranging for the return of all NeoPICC® 1.9 FR Peripherally Inserted Central Catheters.

Medical professionals with questions may contact Arrow Customer Service 24 hours a day, toll free, at 1-800-523-8446.

Do any of you use these and what are you doing with the babies that have these lines already in?

The events that have happened are already risks from using a PICC. We are giving the parents the option of us pulling them and replacing it or continuing to use the line.

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We stopped using them. We are using Vygon catheters instead (some doctors used this anyway)..t.

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We stopped using them. We are using Vygon catheters instead (some doctors used this anyway)..t.

Yeah, we got some of those too. Haven't had a pt with one yet. How do they compare?

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I can't tell that much of a difference. They are tinier, the backflow is a lot faster. But they've used them for the time i've been there (about 3yrs) .t.

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I can't tell that much of a difference. They are tinier, the backflow is a lot faster. But they've used them for the time i've been there (about 3yrs) .t.

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Specializes in Neonatal.

We finally got some Vygons in and already used a few. Actually just the other day one clotted off on a baby and we had to pull it. Very scary pulling it because it is very elastic and when you pull it gets tension like its going to snap. So far our unit doesn't care for them and they are harder insert (so I have been told) and tape comfortably for the babies.

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I have to say after working with these the past few week, it's hard to screw lines into the ends. Makes me nervous I'm going to find a kid in a puddle of blood and fliud one day! :uhoh21:

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Specializes in NICU, PICU, educator.

I agree..the ends are hard to work with! We have been taping our connections. Also, we can't use our Alaris pumps..the pressure doesn't go high enough and they constantly alarm...we had to change over to the Baxters and set it for the maximum pressure. That makes me nervous!

As for the old neopiccs...they all got pulled regardless. Our legal said to take no chances.

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We were using those, and we decided to leave in the ones already in place, since it was a voluntary recall, and it seemed random.....this is a potential complication of ANY PICC. Now we are using the old Bard Per-q-caths. Hate them.

Looking forward to getting NeoPiccs back!

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