Allegedly Defective Balt USA Catheters Issued a Class I Recall Due to Serious Health and Death Risks
SANTA ANA, Calif. — The U.S. Food and Drug Administration has announced a recall of select Balt USA catheters after a manufacturing defect was discovered involving hydrophilic coating found inside the device’s inner tubing. The recall is classified as a Class I event, the agency’s most serious designation, indicating that use of the device could…