Cardinal Health 203, Inc

Recalled ventilators were manufactured prior to September 2003. Models LTV 1000, 950, 900, and 900 Model contain serial numbers less than A006500, C07000, B03500, and D01400, respectively.

Anesthesiology Devices

2

No

Nationwide and worldwide

The LTV Series ventilators provides continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation. This is a prescription medical device intended for use by personnel under the direction of a physician. The ventilator is suitable for use in institutional, home and transport settings.

Lot number: UK0335101, UK0400602, UK0404202, UK0408406, UK0410704, UK0412510, UK0424602, UK0427801, UK0430110, UK0433602, UK0504203, UK0508201

Anesthesiology Devices

2

No

Worldwide Distribution --- USA including Puerto Rico and countries of Algeria, Argentina, Australia, Austria, Bahamas, Belgium, Brazil, Canada, Chile, China Peoples Republic, Colombia, Denmark, Finland, France, Germany, Greece, Hong Kong, India, Indonesia, Israel, Italy, Japan, Malaysia, Mexico, New Zealand, Norway, Panama, Paraguay, Philippines, Portugal, Saudi Arabia, Serbia & Montenegro, Singapore, South Africa, South Korea, Spain, Sri Lanka, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, Vietnam, and West Indies.

Replacement Kit, Power PCBA, REF 17345-001. only distributed outside the US. || Pulmonetic Systems, 17400 Medina Rd., Suite 100, Minneapolis, MN 55447, USA.

Lot number: PWRMK0325902, PWRMK0407201, PWRMK0420105, PWRMK0436501, PWRMK0501101, PWRMK0504603, PWRMK0505402, PWRMK0506602, PWRMK0510303, PWRMK0510804, PWRMK0512201, PWRMK0512303, PWRMK0514313, PWRMK0515201, PWRMK0515701, PWRMK0517802, PWRMK0518701, PWRMK0526503

Anesthesiology Devices

2

No

Worldwide Distribution --- USA including Puerto Rico and countries of Algeria, Argentina, Australia, Austria, Bahamas, Belgium, Brazil, Canada, Chile, China Peoples Republic, Colombia, Denmark, Finland, France, Germany, Greece, Hong Kong, India, Indonesia, Israel, Italy, Japan, Malaysia, Mexico, New Zealand, Norway, Panama, Paraguay, Philippines, Portugal, Saudi Arabia, Serbia & Montenegro, Singapore, South Africa, South Korea, Spain, Sri Lanka, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, Vietnam, and West Indies.

Replacement Kit, Power PCBA with Memory PCBA. REF 14425. || Pulmonetic Systems, 17400 Medina Rd., Suite 100, Minneapolis, MN 55447, USA.

Lot number: RKPWR0323911, RKPWR0325801, RKPWR0326802, RKPWR0328802, RKPWR0329504, RKPWR0330701, RKPWR0331801, RKPWR0334504, RKPWR0416008, RKPWR0420104, RKPWR0423903, RKPWR0430201, RKPWR0430803, RKPWR0434902, RKPWR0435702, RKPWR0502401, RKPWR0503901, RKPWR0504602, RKPWR0505403, RKPWR0506601, RKPWR0507701, RKPWR0508211, RKPWR0509501, RKPWR0510302, RKPWR0510803, RKPWR0511501, RKPWR0511904, RKPWR0514312, RKPWR0515202, RKPWR0516002, RKPWR0516602, RKPWR0519302, RKPWR0525802

Anesthesiology Devices

2

No

Worldwide Distribution --- USA including Puerto Rico and countries of Algeria, Argentina, Australia, Austria, Bahamas, Belgium, Brazil, Canada, Chile, China Peoples Republic, Colombia, Denmark, Finland, France, Germany, Greece, Hong Kong, India, Indonesia, Israel, Italy, Japan, Malaysia, Mexico, New Zealand, Norway, Panama, Paraguay, Philippines, Portugal, Saudi Arabia, Serbia & Montenegro, Singapore, South Africa, South Korea, Spain, Sri Lanka, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, Vietnam, and West Indies.

Replacement Kit, Power PCBA without Memory Board. REF 14157. Pulmonetic Systems, 17400 Medina Rd., Suite 100, Minneapolis, MN 55447, USA.

Lot number: PWRRK0324502, PWRRK0327403, PWRRK0334402, PWRRK0336401, PWRRK0402801, PWRRK0405015, PWRRK0406201, PWRRK0408407, PWRRK0419801, PWRRK0427307, PWRRK0429501, PWRRK0430301, PWRRK0434102, PWRRK0435701, PWRRK0501302, PWRRK0505404, PWRRK0515203, PWRRK0516001, PWRRK0526901, PWRRK0527803.

Anesthesiology Devices

2

No

Worldwide Distribution --- USA including Puerto Rico and countries of Algeria, Argentina, Australia, Austria, Bahamas, Belgium, Brazil, Canada, Chile, China Peoples Republic, Colombia, Denmark, Finland, France, Germany, Greece, Hong Kong, India, Indonesia, Israel, Italy, Japan, Malaysia, Mexico, New Zealand, Norway, Panama, Paraguay, Philippines, Portugal, Saudi Arabia, Serbia & Montenegro, Singapore, South Africa, South Korea, Spain, Sri Lanka, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, Vietnam, and West Indies.

Replacement Kit, Power PCBA with DC power cord. REF 11590. || Pulmonetic Systems, 17400 Medina Rd., Suite 100, Minneapolis, MN 55447, USA.