Device Recall STERIDYNE STERILE PRESERVED SALINE SOLUTION 의 리콜

Recall

54656

Class 2

Z-1224-2010

2010-02-03

2010-04-02

Terminated

United States

2011-01-05

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=88911

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.

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.