Lot Numbers:  13F17D0240 13F17G0371 13F17K0408

Anesthesiology Devices

2

No

US Nationwide, AUSTRALIA, AUSTRIA, BELGIUM, CANADA, CZECH REPUBLIC, DENMARK, ECUADOR, FRANCE, GERMANY, GREECE, HONG KONG, INDONESIA, IRELAND, ITALY, JAPAN, KOREA, NETHERLANDS, NEW ZEALAND, PANAMA, PHILIPPINES, POLAND, PUERTO RICO, ROMANIA, SAUDI ARABIA, SINGAPORE, SLOVENIA, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, THAILAND, TRINIDAD AND TOBAGO, UNITED KINGDOM

0.2 Micron Flat Epidural Filter; Product Code: EF-05500

Lot Numbers:  13F17C0328 13F17F0296 13F17G0202 13F17H0104 13F17J0207

General Hospital and Personal Use Devices

2

No

US Nationwide, AUSTRALIA, AUSTRIA, BELGIUM, CANADA, CZECH REPUBLIC, DENMARK, ECUADOR, FRANCE, GERMANY, GREECE, HONG KONG, INDONESIA, IRELAND, ITALY, JAPAN, KOREA, NETHERLANDS, NEW ZEALAND, PANAMA, PHILIPPINES, POLAND, PUERTO RICO, ROMANIA, SAUDI ARABIA, SINGAPORE, SLOVENIA, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, THAILAND, TRINIDAD AND TOBAGO, UNITED KINGDOM

10 cc Luer-Slip Loss of Resistance Syringe; Product Code: LR-05501

Catalog/Model number CL-07011, Lot number CF03075226

General Hospital and Personal Use Devices

2

No

The products were shipped to medical facilities in AR, CA, NH, VA and VT. The product was also shipped to a distributor in Srialanka

10 FR Super Arrow-Flex Percutaneous Sheath Introducer Set

see list | see list | see list

MD: Cardiac catheter, balloon, intra-aortic

Lot Numbers:  13F17A0199 13F17C0048 13F17D0270 13F17F0258 13F17G0529

Cardiovascular Devices

2

No

US Nationwide, AUSTRALIA, AUSTRIA, BELGIUM, CANADA, CZECH REPUBLIC, DENMARK, ECUADOR, FRANCE, GERMANY, GREECE, HONG KONG, INDONESIA, IRELAND, ITALY, JAPAN, KOREA, NETHERLANDS, NEW ZEALAND, PANAMA, PHILIPPINES, POLAND, PUERTO RICO, ROMANIA, SAUDI ARABIA, SINGAPORE, SLOVENIA, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, THAILAND, TRINIDAD AND TOBAGO, UNITED KINGDOM

4Fr. Catheter Clamp with Fastener; Product Code: CC-00004

4FR Single Lumen Pressure Injectable Peripherally Inserted Central Catheter (PICC)Catalogue number: PR-05041-HPARTG Number: 148784

General Hospital and Personal Use Devices

Aortic Balloon catheters-cardiology

5800 Series FibreOptix ™ and Ultra 8 ® Catheters CC IAB Catheters

Cardiovascular Devices

medical_device

Lot Numbers:  13F17A0198 13F17C0056 13F17D0135 13F17D0236 13F17F0075 13F17F0600 13F17G0179 13F17H0107 13F17H0367 13F17J0198 13F17K0212

Cardiovascular Devices

2

No

US Nationwide, AUSTRALIA, AUSTRIA, BELGIUM, CANADA, CZECH REPUBLIC, DENMARK, ECUADOR, FRANCE, GERMANY, GREECE, HONG KONG, INDONESIA, IRELAND, ITALY, JAPAN, KOREA, NETHERLANDS, NEW ZEALAND, PANAMA, PHILIPPINES, POLAND, PUERTO RICO, ROMANIA, SAUDI ARABIA, SINGAPORE, SLOVENIA, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, THAILAND, TRINIDAD AND TOBAGO, UNITED KINGDOM

5Fr. Catheter Clamp with Fastener; Product Code: CC-00005

Lot Numbers:  13F17B0257 13F17D0260 13F17E0342 13F17F0076 13F17F0795 13F17J0271

Cardiovascular Devices

2

No

US Nationwide, AUSTRALIA, AUSTRIA, BELGIUM, CANADA, CZECH REPUBLIC, DENMARK, ECUADOR, FRANCE, GERMANY, GREECE, HONG KONG, INDONESIA, IRELAND, ITALY, JAPAN, KOREA, NETHERLANDS, NEW ZEALAND, PANAMA, PHILIPPINES, POLAND, PUERTO RICO, ROMANIA, SAUDI ARABIA, SINGAPORE, SLOVENIA, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, THAILAND, TRINIDAD AND TOBAGO, UNITED KINGDOM

7Fr. Catheter Clamp with Fastener; Product Code: CC-00007

Lot Numbers:  13F17B0050 13F17D0271 13F17F0078 13F17J0276

Cardiovascular Devices

2

No

US Nationwide, AUSTRALIA, AUSTRIA, BELGIUM, CANADA, CZECH REPUBLIC, DENMARK, ECUADOR, FRANCE, GERMANY, GREECE, HONG KONG, INDONESIA, IRELAND, ITALY, JAPAN, KOREA, NETHERLANDS, NEW ZEALAND, PANAMA, PHILIPPINES, POLAND, PUERTO RICO, ROMANIA, SAUDI ARABIA, SINGAPORE, SLOVENIA, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, THAILAND, TRINIDAD AND TOBAGO, UNITED KINGDOM

8Fr. Catheter Clamp with Fastener; Product Code: CC-00008

Lot Numbers:  13F17H0405

Cardiovascular Devices

2

No

US Nationwide, AUSTRALIA, AUSTRIA, BELGIUM, CANADA, CZECH REPUBLIC, DENMARK, ECUADOR, FRANCE, GERMANY, GREECE, HONG KONG, INDONESIA, IRELAND, ITALY, JAPAN, KOREA, NETHERLANDS, NEW ZEALAND, PANAMA, PHILIPPINES, POLAND, PUERTO RICO, ROMANIA, SAUDI ARABIA, SINGAPORE, SLOVENIA, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, THAILAND, TRINIDAD AND TOBAGO, UNITED KINGDOM

9 Fr. Radiopaque || Polyurethane Sheath/Dilator || with Integral Hemostasis Valve/Side Port || for use with 7 - 8 Fr. Catheters and || Arrow Percutaneous Introducer System; Product codes: SS-09903-S

ASK-03000-CHUQ Lot Numbers: RF7125131, RF8044816, RF9056379, RL8088126 and RL8118762.  ASK-3000-CHUQ1 Lot Numbers: RF0076695, RF9056277, RF9071611, RF9113177 and RF9127313.  ASK-04001-GFH Lot Numbers: RF0019576, RF0050476 and RF0063762.  ASK-04001-SUH Lot Numbers: RF0018516, RF0022619, RF0035227, RF0062121, RF0076516, RF9015142, RF9028180, RF9057183, RF9086014, RF9109959, RF9114930 and RL8129036.  ASK-04001-UHC Lot Numbers: RF0018444, RF0048049, RF0088324, RF8057019, RF8084220, RF8123782, RF9031837, RF9084607, RF9097370 and RF9101531.

Anesthesiology Devices

2

No

Worldwide Distribution -- United States - all 50 States, and the countries of Canada, South America, China, South Africa, Australia, Puerto Rico, Philippines, Singapore, South Korea, New Zealand, Mexico, Japan, India, Indonesia, Bahamas, Taiwan, Thailand, Finland, France, Cyprus, Czech Republic, Belgium, Germany, Ireland, Italy, Latvia, Netherlands, Poland, Slovakia, Spain, Bahamas, Costa Rico, Dominican Republic, Ecuador, Guatamala and the United Kingdom.

ACCESS TRAY/Product SKU's (Codes) ASK-03000-CHUQ, ASK-03000-CHUQ1, ASK-04001-GFH, ASK-04001-SUH and ASK-04001-UHC. || Access tray for epidural anesthesia kit

medical_device

see letter

MD: Nebulizing adaptor

md

md