Product: Halyard 24-Hour Oral Care Kit q4, contains 2x15 mL Unit Dose Cups 0.12% Chlorhexidine Gluconate Oral Rinse.  Manufactured by Halyard Health Inc., 5405 Windward Parkway, Alpharetta, GA 30004. Distributed by Halyard Sales, LLC Alpharetta, GA 30004. REF # 97014
Reason for recall: Crystallization with subpotent out of  specification assay results for chlorhexidine.
Recall initiated: 20170712
Status: Terminated
Classification: Class III
Recall type: Voluntary: Firm initiated