Cardinal Health 203, Inc Replacement Kit, Power PCBA with DC power cord. REF 11590. Pulmonetic Systems, 17400 Medina Rd., Suite 100, Minneapolis, MN 55447, USA. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Replacement Kit, Power PCBA with DC power cord. REF 11590. Pulmonetic Systems, 17400 Medina Rd., Suite 100, Minneapolis, MN 55447, USA.
Brand
Cardinal Health 203, Inc
Lot Codes / Batch Numbers
Lot number: PWRRK0324502, PWRRK0327403, PWRRK0334402, PWRRK0336401, PWRRK0402801, PWRRK0405015, PWRRK0406201, PWRRK0408407, PWRRK0419801, PWRRK0427307, PWRRK0429501, PWRRK0430301, PWRRK0434102, PWRRK0435701, PWRRK0501302, PWRRK0505404, PWRRK0515203, PWRRK0516001, PWRRK0526901, PWRRK0527803.
Products Sold
Lot number: PWRRK0324502, PWRRK0327403, PWRRK0334402, PWRRK0336401, PWRRK0402801, PWRRK0405015, PWRRK0406201, PWRRK0408407, PWRRK0419801, PWRRK0427307, PWRRK0429501, PWRRK0430301, PWRRK0434102, PWRRK0435701, PWRRK0501302, PWRRK0505404, PWRRK0515203, PWRRK0516001, PWRRK0526901, PWRRK0527803.
Cardinal Health 203, Inc is recalling Replacement Kit, Power PCBA with DC power cord. REF 11590. Pulmonetic Systems, 17400 Medina Rd., due to 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 proper. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
PR
Page updated: Jan 10, 2026