Product: Proplete 70+ KG (Intraperitoneal Parenteral Nutrition - dialysate solution with added amino acids), in a) 635mL bag and b) 660mL bag, Pentec Health Inc  4 Creek Parkway Suite A Boothwyn, PA  19061-3132
Reason for recall: Lack of Assurance of Sterility: Sterility could not be assured for compounded sterile renal nutritional prescriptions
Recall initiated: 20130515
Status: Terminated
Classification: Class II
Recall type: Voluntary: Firm initiated