Arrow initiates Class I recall of venous catheter
Arrow International, a subsidiary of Teleflex, has declared a Class I recall of its Multi-Lumen Venous catheterization set with Blue FlexTip Arrowg+ard catheter.
The device’s labeling erroneously states that the product "contains no medication;” however, the device contains chlorhexidine and silver sulfadiazine. Additionally, the product’s label is missing the appropriate chlorhexidine contraindication, according to the FDA recall notice. The product was manufactured from June 28, 2010, through March 4, 2012, and distributed from Dec. 9, 2010, through Feb. 29, 2012.
If a patient with a known or unknown allergy/sensitivity to chlorhexidine or silver sulfadiazine/sulfa drug is exposed to this product, the FDA said that 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, the agency said.
On May 3, Arrow sent its distributors an urgent field correction action letter, which asked their distributors to quarantine any affected inventory and relay the information to their Arrow sales representatives, who will place a new label on each kit within their inventory.
Class I recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death.
The device’s labeling erroneously states that the product "contains no medication;” however, the device contains chlorhexidine and silver sulfadiazine. Additionally, the product’s label is missing the appropriate chlorhexidine contraindication, according to the FDA recall notice. The product was manufactured from June 28, 2010, through March 4, 2012, and distributed from Dec. 9, 2010, through Feb. 29, 2012.
If a patient with a known or unknown allergy/sensitivity to chlorhexidine or silver sulfadiazine/sulfa drug is exposed to this product, the FDA said that 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, the agency said.
On May 3, Arrow sent its distributors an urgent field correction action letter, which asked their distributors to quarantine any affected inventory and relay the information to their Arrow sales representatives, who will place a new label on each kit within their inventory.
Class I recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death.