FDA Medical Device Recalls (openFDA)
Cardinal Health 203, Inc: Replacement Kit, Power PCBA without Memory Board. REF 14157. Pulmonetic Systems, 17400 Medina Rd., Suite 100, Minneapolis, MN 55447, USA.
- Recall number
- Z-1468-2008
- Recalling firm
- Cardinal Health 203, Inc
- Product
- Replacement Kit, Power PCBA without Memory Board. REF 14157. Pulmonetic Systems, 17400 Medina Rd., Suite 100, Minneapolis, MN 55447, USA.
- Status
- Terminated
- Initiated
- 2008-02-22
- Posted
- 2008-08-13
- Terminated
- 2012-08-16
- Reason
- The failure of an electronic component could result in failure of the ventilator to breathe for the patient and/or failure of the ventilator to properly alarm to alert the caregiver.
- Root cause
- Device Design
- Action
- An Urgent Medical Device Recall letter dated February 22, 2008 was sent to ventilator consignees/owners and distributors. The letter describes the issue, identifies the affected devices, states that the devices will be corrected by Cardinal Health and provides direction to verify ventilator operation and audible alarm function daily. Service Centers were provided information to identify affected printed circuit board assembly replacement kits' lot numbers and asked to return them. An "Update" was mailed 03/04/2008 to identify additional ventilator serial numbers that also need correction.
- Quantity
- 3,368 (1,892 US, 1,476 OUS)
- Distribution
- 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.
- Lot, serial or model codes
- 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
- 510(k) numbers
- ["K002881","K010508","K040540","K981371","K984056"]
- PMA numbers
- not on file
- Product code
- CBK
- Firm FEI
- 3002617992
- Firm city
- Minneapolis
- Firm state
- MN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28