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.