Baxter

Product code 5C4482, lot number H09E19059.

Gastroenterology-Urology Devices

2

No

US (states of Arkansas, Illinois, Mississippi, North Carolina, Tennessee and Virginia) and El Salvador.

Baxter Minicap Extended Life PD Transfer Set (6") with Twist Clamp; six sets per carton; Baxter Healthcare Corporation, Deerfield, IL 60015 USA; product code 5C4482 The set is used in disconnect applications and cycler applications where aseptic connections and disconnections are performed at the transfer set/cycler juncture.

Product code 5C4483, lot number H09E18044.

Gastroenterology-Urology Devices

2

No

US (states of Arkansas, Illinois, Mississippi, North Carolina, Tennessee and Virginia) and El Salvador.

Baxter Minicap Extended Life PD Transfer Set Extra Short (4") with Twist Clamp; six sets per carton; Baxter Healthcare Corporation, Deerfield, IL 60015 USA; product code 5C4483 The set is used in disconnect applications and cycler applications where aseptic connections and disconnections are performed at the transfer set/cycler juncture.

Product code 2C8864; Lot number UR09E21238.

General Hospital and Personal Use Devices

2

No

Worldwide Distribution -- United States (Alabama, California, Colorado, Florida, Georgia, Illinois, Kentucky, Louisiana, Michigan, Mississippi, Missouri, Nevada, New Mexico, Ohio, Tennessee, Texas, Utah and Wisconsin), Canada and New Zealand.

Buretrol Solution Sets, a sterile fluid pathway of 105 (2.7 m), 60 drops/mL, with 150 mL Burette Drip Chamber Filter Valve, 2 injection Y-sites, 3 Luer Activated Valves and Male Luer Lock Adapter with Retractable Collar; 48 individually pouched sterile sets per case; Baxter Healthcare Corporation, Deerfield, IL 60015 U.S.A. || A sterile fluid pathway used to administer fluids from a container to a patient's vascular system through a vascular access device.

All Baxter 1550 instruments and/or spare circuit boards that do not have software versions 3.0A or 4.1B

Gastroenterology-Urology Devices

2

No

Worldwide Distribution -- United States - nationwide and Puerto Rico, Argentina, Brazil, Canada, Chile, China, Colombia, Ecuador, Guatemala, Honduras, Mexico, Panama, Philippines, Romania, Turkey and Venezuela.

Baxter 1550 Single Patient System Hemodialysis Machines; Baxter Healthcare Corporation, Deerfield, IL 60015; product codes 5M5538, 5M5538R, 5M5575, 5M5551 and 5M5551R.

Lot number: G076802

Clinical Chemistry and Clinical Toxicology Devices

2

No

United States -- Nationwide and Puerto Rico, Canada and Saudi Arabia

Baxter RenAmin (Amino Acid) Injection; Pharmacy Bulk Package Not for Direct Infusion, Rx Only, 250 mL type II glass bottles; Baxter Healthcare Corporation, Clintec Nutrition Division, Deerfield, IL 60015 USA, Made in USA; product code 2A6222.