Medtronic SynchroMed EL

Model 8627-10, serial numbers: NGE000001 - NGE000242R .  Model 8627-18, serial numbers: NGF000001 - NGF003266R.  Model 8627L-10, serial numbers: NGG000001R - NGG000068R,  Model 8627L-18, serial numbers: NGH000001R - NGH001780R.

General Hospital and Personal Use Devices

3

Yes

Worldwide distribution ---- including USA, Argentina, Barbados, Canada, Germany, India, Ireland, Italy, Mexico, The Netherlands, Spain, Switzerland, and United Kingdom.

Medtronic SynchroMed EL Programmable Pumps, Models 8627-10, 8627-18, 8627L-10, 8627L-18. The implantable Medtronic SynchroMed EL Programmable Pump is part of the SynchroMed EL Infusion System designed to contain and administer parenteral drugs to a specific site. The implantable components of the SynchroMed EL Infusion System include the pump with or without a side catheter access port, catheters, and catheter accessories.

General Hospital and Personal Use Devices

3

Yes

Worldwide: USA including states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY and countries of HONG KONG, AUSTRALIA, CANADA, AUSTRIA, BELGIUM, CROATIA, The CZECH REPUBLIC, DENMARK, EGYPT, FINLAND, FRANCE, GERMANY, HUNGARY, IRAN, ICELAND, IRELAND, ITALY, THE NETHERLANDS, NORWAY, POTUGAL, SAN MARINO, SAUDI ARABIA, SPAIN, SWEDEN, SWITERLAND, TURKEY, UNITED ARAB EMIRATES, UNITED KINGDOM, IRAQ, BRAZIL, and MEXICO.

Medtronic SynchroMed EL Programmable Pump, Model 8627L-18. Medtronic, Inc., 710 Medtronic Parkway, Minneapolis, MN 55432-5604 USA.--(The implantable Medtronic SynchroMed EL Programmable Pump is part of the SynchroMed EL Infusion System designed to contain and administer parenteral drugs to a specific site)

See codes for all models in associated Recall Z-0950-2008

General Hospital and Personal Use Devices

3

Yes

Worldwide-USA including states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, DS, TN, TX, UT, VA, VT, WA, WI, WV, and WY, and countries of HONG KONG, JAPAN, AUSTRALIA, CANADA, BELGIUM, CROATIA, AUSTRIA, CYPRUS, The CZECH REPUBLIC, DENMARK, EGYPT, FINLAND, FRANCE, GERMANY, GREECE, HUNGARY, INDIA, IRAN, ICELAND, IRELAND, ITALY, JORDAN, KWAIT, LEBANON, MALTA, The NETHERLANDS, NORWAY, POLAND, PORTUGAL, SAN MARINO, SAUDI ARABIA, SLOVENIA, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, TUNISIA, TURKEY, UNITED ARAB EMIRATES, The UNITED KINGDOM, CHILE, VENEZUELA, BRAZIL, and MEXICO.

Medtronic SynchroMed EL Programmable Pumps, Model 8627L-18, Medtronic, Inc., 710 Medtronic Parkway, Minneapolis, MN 55432-5604 USA. (The implantable Medtronic SynchroMed EL Programmable Pump is part of the SynchroMed EL Infusion System designed to contain and administer parenteral drugs to a specific site)

All serial numbers

General Hospital and Personal Use Devices

3

Yes

Worldwide Distribution -- USA including states of Washington D.C., Puerto Rico, and countries of Aruba, Australia, Austria, Belarus, Belgium, Brazil, Canada, China, Croatia, Cyprus, Czech Republic, Denmark, Dominican Republic, Egypt, Faroe Islands, Finland, France, French Polynesia, Germany, Greece, Guadeloupe, Hong Kong, Hungary, Iceland, India, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kuwait, Lebanon, Luxembourg, Malta, Mexico, Netherlands, Netherlands Antilles, New Caledonia, Norway, Pakistan, Poland, Portugal, Reunion, Romania, Russian Federation, San Marino, Saudi Arabia, Serbia and Montenegro, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Tunisia, Turkey, United Arab Emirates, United Kingdom, Vatican City State.

Medtronic - SynchroMed EL Implantable Infusion Pump, Model Number: 8626-10. The contents of the inner package have been sterilized by ethylene oxide gas. 10 mL pump with reservoir valve. Medtronic, Inc., 710 Medtronic Parkway NE, Minneapolis, MN 55432-5604, USA. The implantable Medtronic SynchroMed EL Programmable Pump is part of the SynchroMed EL Infusion System designed to contain and administer parenteral drugs to a specific site. The implantable components of the SynchroMed EL Infusion System include the pump with or without a side catheter access port, catheters, and catheter accessories.

all serial numbers

General Hospital and Personal Use Devices

3

Yes

Worldwide Distribution -- USA including states of Washington D.C., Puerto Rico, and countries of Aruba, Australia, Austria, Belarus, Belgium, Brazil, Canada, China, Croatia, Cyprus, Czech Republic, Denmark, Dominican Republic, Egypt, Faroe Islands, Finland, France, French Polynesia, Germany, Greece, Guadeloupe, Hong Kong, Hungary, Iceland, India, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kuwait, Lebanon, Luxembourg, Malta, Mexico, Netherlands, Netherlands Antilles, New Caledonia, Norway, Pakistan, Poland, Portugal, Reunion, Romania, Russian Federation, San Marino, Saudi Arabia, Serbia and Montenegro, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Tunisia, Turkey, United Arab Emirates, United Kingdom, Vatican City State.

Medtronic SynchroMed EL Implantable Infusion Pump, model 8627L-18. The contents of the inner package have been sterilized by ethylene oxide gas. 18 mL pump with reservoir valve, screened side catheter access port and suture loops. Medtronic, Inc., 710 Medtronic Parkway NE, Minneapolis, MN 55432-5604, USA. The implantable Medtronic SynchroMed EL Programmable Pump is part of the SynchroMed EL Infusion System designed to contain and administer parenteral drugs to a specific site. The implantable components of the SynchroMed EL Infusion System include the pump with or without a side catheter access port, catheters, and catheter accessories.