Parker Waichman LLP

Class I Recall Launched for Arrow International Venous Catheterization Set

A Class I recall was launched for Arrow International’s Venous Catheterization Set, the U.S. Food & Drug Administration (FDA) just announced. An FDA Class I designation is the agency’s most serious type of recall and involves situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences […]

A Class I recall was launched for Arrow International’s Venous Catheterization Set, the U.S. Food & Drug Administration (FDA) just announced. An FDA Class I designation is the agency’s most serious type of recall and involves situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death.

The recall involved Arrow International’s Multi-Lumen Venous Catheterization Set with Blue FlexTip ARROWg+ard Catheter. A list of involved part and lot numbers can be accessed on the FDA’s web site.

The recalled multiple-lumen catheter was manufactured from June 28, 2010 through March 4, 2012 and distributed from December 9, 2010 through February 29, 2012. The catheter is used for insertion into a large vein to administer drug therapy. Arrow International, Inc., a subsidiary of Teleflex, Inc., is located at 2400 Bernville Road, Reading, Pennsylvania, 19605

The Arrow International Venous Catheterization Set’s labeling erroneously states that the product “contains no medication”; however, the device contains chlorhexidine and silver sulfadiazine. Also, the product’s label is missing the appropriate chlorhexidine contraindication. If a patient with a known or unknown allergy/sensitivity to chlorhexidine or silver sulfadiazine/sulfa drug is exposed to this product, there is the potential for an allergic reaction such as a delayed rash; hives; or, potentially, an immediate Type 1, IgE mediated anaphylaxis, which involves loss of blood pressure, bronchospasm, and vascular collapse

On May 3, 2012, the firm sent its distributors an Urgent Field Correction Action letter. In the letter, the firm asked its distributors to quarantine affected inventory and relay the information to their Arrow sales representatives. The Arrow sales representatives will place a new label on each kit within their inventories. Arrow International, Inc. can be reached at 1.610.378.0131.

Last year, Arrow International Inc. recalled certain lots of its NextStep Antegrade Chronic Hemodialysis Catheters in another a Class I recall after it received complaints indicating breakage and/or separation of the stylet within the catheters. Those Arrow catheters are indicated for use in adult patients for attaining long-term vascular access for hemodialysis and apheresis. Chronic hemodialysis catheters are typically placed into a large vein in the patient’s neck.

The prior year, Arrow International recalled its Ultra 8 Intra-Aortic Balloon Catheters (IABS) 8 FR 30CC and 40CC Universal and Arrow Intra-Aortic Balloon (IAB) Catheter with a Fiber Optic Sensor and Measurement System, used in the treatment of a variety of cardiac conditions, including heart failure, septic shock, and myocardial infarction. They are also used to support and stabilize high-risk patients undergoing diagnostic and non-surgical procedures. Those catheters could become stuck in the sheath, rendering the user unable to move the IAB catheter forward or backward, causing a delay in therapy, bleeding, or arterial injury.

What Our Clients Say About Us
We have worked with thousands of clients and we appreciate them and their positive reviews. Here are just a few recent client reviews...
5 Star Reviews 150
Positive: Professionalism Well there is always room for improvement but I've been satisfied with the communication with all that were involved with my case.
Kevin Fulton
2 years ago
5 Star Reviews 150
Parker Waichman was there for me when I needed them. They came through 100% x 10.. I highly recommend Parker Waichman LLP.
Even Levee
a month ago
5 Star Reviews 150
Cases apparently take some time to resolve, the staff has worked diligently for a resolution in my case and I appreciate the hard work being done over this period of time.
Valerie Maddox
5 years ago

Why Choose Us to Help You?

We Take Care of Everything
Your situation is stressful enough: Let us take on the deadlines, paperwork, investigation, and litigation. We'll handle every detail so you don't have to worry.
No Recovery = No Legal Fees
We work on a contingency-fee basis, meaning that we only get paid from a portion of your settlement or jury award. If you don't get compensation, you owe us nothing.
Decades of Experience
Your situation is stressful enough: Let us take on the deadlines, paperwork, investigation, and litigation. We'll handle every detail so you don't have to worry.
Respected by Our Peers
Judges, insurance adjusters, and fellow attorneys all speak highly of our skills, and we've earned numerous accolades, including a flawless rating from AVVO.
We Have Many Locations To Serve You
We have the experience and the skilled litigators to win your case. Contact us and speak with a real attorney who can help you.
Long Island – Nassau
Parker Waichman LLP
6 Harbor Park Drive
Port Washington, NY 11050
Long Island – Suffolk
Parker Waichman LLP
201 Old Country Road – Suite 145
Melville, NY 11747
New York
Parker Waichman LLP
59 Maiden Lane, 6th Floor
New York, NY 10038
Queens
Parker Waichman LLP
118-35 Queens Boulevard, Suite 400
Forest Hills, NY 11375
Brooklyn
Parker Waichman LLP
300 Cadman Plaza West
One Pierrepont Plaza, 12th Floor
Brooklyn, NY 11201
New Jersey
Parker Waichman LLP
80 Main Street, Suite 265
West Orange, NJ 07052
Florida
Parker Waichman LLP
27299 Riverview Center Boulevard
Suite 108
Bonita Springs, FL 34134
Nationwide Service
Parker Waichman LLP
59 Maiden Lane, 6th Floor
New York, NY 10038