Sterile Water

Model: Part Number: 003-40, Affected: Selected lots

medical_device

catalog number 037-00, lot 150150, exp. 2009-10

Anesthesiology Devices

2

No

Colorado, Nebraska, Oregon, Minnesota, California, Pennsylvania, Michigan, Louisiana, Oklahoma and Texas.

AquaPak Sterile Water for Inhalation, USP, 760 mL blow-molded plastic bottle for use with a respiratory gas humidifier; 10 bottles per case; manufactured by Hudson Respiratory Care, Inc., Temecula, CA 92589-9020 USA; catalog #037-00

Lot 600783 Exp Feb-08 Lot 600815 Exp Jan-08 Lot 600874 Exp Feb-08 Lot 600875 Exp Jan-08 Lot 600814 Exp Jan-08 Lot 600771 Exp Jan-08 Lot 600692 Exp Dec-07 Lot 600540 Exp Nov-07 Lot 600630 Exp Dec-07 Lot 600538 Exp Dec-07 Lot 600408 Exp Dec-07 Lot 600145 Exp Sep-07 Lot 600146 Exp Sep-07 Lot 600147 Exp Sep-07

Gastroenterology-Urology Devices

3

No

Products were distributed to one distributor in MA and eight medical device users in MA, IL, NJ, FL, NY, CO, OH, and MI.

Prolieve¿ Thermodilatation¿ Kit, consisting of a Prolieve Thermodilatation Catheter, Prolieve Heat Exchanger cartridge and 500 ml bag of sterile water, Catalog # 880-8023, Material Number M0068808023, labeled in part *** Distributed by Boston Scientific Corporation, Natck, MA***Manufacturer: Celsion Corporation, Columbia, MD***.

Product code: UKF7114, Batch number 12H28B27

Sterile Water, irrigation