Product: 0.2% ROPivacaine - OnQ Pump, (ROPivacaine HCL (USP) 1100mg, 0.9% Sodium Chloride (USP) QS 550 ml, single dose pump. For: Vidant Medical Center, By: Avella of Houston, 9265 Kirby Dr., Houston, TX 77056. NDC: 42852-661-02
Reason for recall: Lack of Assurance of Sterility: Potential leakage of bags.
Recall initiated: 20180612
Status: Terminated
Classification: Class II
Recall type: Voluntary: Firm initiated