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

Recall Number: D-0928-2018

Firm: Avella of Deer Valley, Inc. Store 38

Classification: Class II

Status: Terminated

Report Date: 20180725

Initiation Date: 20180612

Termination Date: 20200124

Reason for Recall

Lack of Assurance of Sterility: Potential leakage of bags.

Product Description

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