Class 2 Device Recall STERIDYNE STERILE PRESERVED SALINE SOLUTION

• Date Initiated by Firm: February 03, 2010
• Date Posted: April 02, 2010
• Recall Status: Terminated on January 05, 2011
• Recall Number: Z-1226-2010
• Recall Event ID: 54656
• PMA Number: P930005
• Product Classification: Accessories, solution, ultrasonic cleaners for lenses - Product Code LYL
• Product: Kroger Sterile Preserved Saline Solution 12oz, Product SKU#011110-385956. This product is supplied in 12 fl. oz. (355 mL) bottles for use in rinsing of soft (hydrophilic) contact lenses after heat (thermal) disinfection and rinsing of contact lenses following chemical disinfection.
• Code Information: Lot #9C523.
• Recalling Firm/ Manufacturer: K C Pharmaceuticals Inc; 3201 Producer Way; Pomona CA 91768-3916
• For Additional Information Contact: Warren Cheung; 909-598-9499 Ext. 41
• Manufacturer Reason for Recall: The recall was initiated because the affected lots were manufactured between two failed media fills; therefore the lots produced cannot be assured as being free of contamination and may not be sterile.
• FDA Determined Cause: Other
• Action: An "Urgent: Medical Device Recall Notification" letter dated February 17, 2010 was issued to customers. Consignees were instructed to immediately hold and discontinue selling the existing, affected stock. Consignees were also instructed to check inventories at all distribution locations for affected products shipped between June 8, 2OO9 and August 7, 2009 and perform a SUBRECALL to the retail level and report back to KC Pharmaceuticals. If the retailers indicate they have any of the affected lots of product, please have them contact KC Pharmaceuticals at 1-888-527-4276 for a shipping authorization number. Consignees were asked to complete the enclosed Recall Effectiveness Check Form, even if they did not have the products in question and return the form to KC Pharmaceuticals via mail within five (5) business days. The recalled lot and completed packing slips were asked to be shipped to: KC Pharmaceuticals-SALP Recall, 3201 Producer Way, Pomona, CA 91768. Direct questions to KC Pharmaceuticals by calling 1-888-527-4276, extension 27.
• Quantity in Commerce: 16,824 units
• Distribution: Nationwide Distribution.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.