FDA has issued a Class I recall notice relating to Teleflex subsidiary Arrow International’s Multi-Lumen Venous Catheterisation Set, following the company’s May Field Corrective Action Letter.
On May 3, Arrow international Inc. sent its distributors an Urgent Field Correction Action letter asking for the quarantining of any affected inventory of product manufactured from June 28, 2010 through March 4, 2012 and distributed from December 9, 2010 through February 29, 2012. Part and Lot numbers affected are available on the FDA’s recall page here.
Apparently the device’s labeling erroneously states that the product “contains no medication,” while in reality the device contains chlorhexidine and silver sulfadiazine. Additionally, the product’s label is missing the appropriate chlorhexidine contraindication.
According to the recall notice, 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 (loss of blood pressure, bronchospasm and vascular collapse).
This product may cause serious adverse health consequences, including death, if used in a patient who is allergic to either chlorhexidine or silver sulfadiazine, which is why the recall has been tagged Class I, the most serious type and reserved for situations in which there is a reasonable probability that use of the product will cause serious adverse health consequences or death.