Zevex International, Inc.

***EXPANDED RECALL*** Lot Codes added 05/12/2011: CF1019717, CF1019719.

General Hospital and Personal Use Devices

2

No

Worldwide Distribution: USA including states of: AR, CA, FL, IA, KS, MS, NE, NY, OH, OK, TN, TX, and UT; and countries including: Australia, Croatia, France, Germany, Kuwait, New Zealand, Qatar, Saudi Arabia, South Africa, United Arab Emirates, and UK.

***EXPANDED RECALL*** Curlin Infusion Administration Set, REF 340-4119, Sterile EO, Zevex, Inc., 4314 Zevex Park Lane, Salt Lake City, UT 84123. || The Curlin Ambulatory Infusion Pump System with disposable PVC Administration Tubing Sets and user accessories, provide a means for the volumetric delivery of fluids used in Parenteral, Enteral, Epidural, Subcutaneous and Intravenous applications.

***EXPANDED RECALL*** Lot Codes added 05/12/2011: CF1025201.

General Hospital and Personal Use Devices

2

No

Worldwide Distribution: USA including states of: AR, CA, FL, IA, KS, MS, NE, NY, OH, OK, TN, TX, and UT; and countries including: Australia, Croatia, France, Germany, Kuwait, New Zealand, Qatar, Saudi Arabia, South Africa, United Arab Emirates, and UK.

***EXPANDED RECALL*** Curlin Infusion Administration Set, REF 340-4175, Sterile EO, Zevex, Inc., 4314 Zevex Park Lane, Salt Lake City, UT 84123. || The Curlin Ambulatory Infusion Pump System with disposable PVC Administration Tubing Sets and user accessories, provide a means for the volumetric delivery of fluids used in Parenteral, Enteral, Epidural, Subcutaneous and Intravenous applications.

***EXPANDED RECALL*** Lot Codes added 05/12/2011: CF1022905.

General Hospital and Personal Use Devices

2

No

Worldwide Distribution: USA including states of: AR, CA, FL, IA, KS, MS, NE, NY, OH, OK, TN, TX, and UT; and countries including: Australia, Croatia, France, Germany, Kuwait, New Zealand, Qatar, Saudi Arabia, South Africa, United Arab Emirates, and UK.

***EXPANDED RECALL*** Curlin Infusion Administration Set, REF 340-4165, Sterile EO, Zevex, Inc., 4314 Zevex Park Lane, Salt Lake City, UT 84123. || The Curlin Ambulatory Infusion Pump System with disposable PVC Administration Tubing Sets and user accessories, provide a means for the volumetric delivery of fluids used in Parenteral, Enteral, Epidural, Subcutaneous and Intravenous applications.

Serial numbers in range: 506297001 - 508290050

General Hospital and Personal Use Devices

2

No

Nationwide, including 1 VA facility in CA. Foreign distribution to 1 consignee in Canada.

EnteraLite Infinity Enteral Feeding Pump, REF INFP01, Zevex Enteral Nutrition Delivery Systems, Salt Lake City, UT 84123. || A rotary peristaltic pump designed to deliver programmed doses of enteral nutrition solutions at selectable rates.

Serial numbers in range: 607129001 - 608275026

General Hospital and Personal Use Devices

2

No

Nationwide, including 1 VA facility in CA. Foreign distribution to 1 consignee in Canada.

Infinity Orange Enteral Feeding Pump, REF INFORNG, Zevex Enteral Nutrition Delivery Systems, Salt Lake City, UT 84123.