Teleflex Medical's ($TFX) Arrow International unit has been slapped with a Class I recall over its Arrowg+ard catheter, which the FDA says was dangerously mislabeled.
Designed to administer therapies within large veins, the catheter is labeled as containing no drugs, but is in fact coated with chlorhexidine and silver sulfadiazine, the agency said. Patients who are allergic to these drugs could experience allergic reactions, including venal failure, possibly leading to death. The FDA tagged the recall with its most serious Class I designation.
Arrow launched a recall on May 3, sending a letter to its distributors asking them to quarantine the affected products, so they can be relabeled with accurate information. The FDA is asking patients already implanted with the catheter to report adverse events through its MedWatch program.
Back in 2007, Arrow got a warning letter from the agency over its manufacturing practices before being acquired by Teleflex, and, once the issue was resolved in 2011, the parent company's CEO said Teleflex had implemented its standards on Arrow's production process.
- read the recall notice