FDA issued a Class II enforcement action. Affects Medline Industries, LP. Reason: A smaller open suction catheter, the 8 Fr Suction Catheter, may have been packed within the kit instead of the required .
A smaller open suction catheter, the 8 Fr Suction Catheter, may have been packed within the kit instead of the required 14 Fr Suction Catheter. Use of the smaller size catheter may result in hypoxi...