Medtronic Gastroenterology / Urology

Lots 0001391 and 0001464

Gastroenterology-Urology Devices

2

No

Worldwide Distribution-including states of IL, NC, NY. and countries of Austria, Chile, Finland, Germany, Greece, Hong Kong, Italy, Japan, Lebanon, Norway, Peru, Portugal, Saudi Arabi, Spain

Medtronic Zinetics Manometric Catheter, Model 9012P2271. Water perfused, motility catheter. Distributed by Medtronic, Inc. 710 Medtronic Parkway NE, Minneapolis, MN 55432-5604 USA.

All serial numbers

Gastroenterology-Urology Devices

2

No

The devices were distributed nationwide in the United States.

Medtronic Gastro pH in a Box System, Model 43A008, Catalog Number 9043A0081

Lot 0001491

Gastroenterology-Urology Devices

1

No

within US only: MI, PA, TX

Medtronic Zinetics 24ME Multi-Use External Reference pH Catheter. For Gastroesophageal pH Measurements. Catalog number 9012P2121. Distributed by Medtronic, Inc., 710 Medtronic Parkway NE, Minneapolis, MN 55432-5604, USA.

Lot numbers 571, 606, 695, 754, 952, 945, 1024, 1066

Gastroenterology-Urology Devices

1

No

CA, CO, FL, MA, OH, PA. OUS to include Finland, Italy and Portugal

Medtronic Slimline Single-Use Internal Reference pH Catheter for Gastroesophageal pH measurements. Models 9012P3101, 9012P3111, 9012P3121, 9012P3131 and 9012P3141. Distributed by / Medtronic Inc. 710 Medtronic Parkway NE, Minneapolis, MN 55432-5604 USA

All serial numbers less than 400,000 are involved.

Gastroenterology-Urology Devices

1

No

The devices were distributed nationwide in the United States and worldwide.

Bravo pH Monitoring System Receiver