Carina Home Ventilator. The device is used as a continuous respirator/ventilator for home use.

FDA device recall Z-1263-2009 · posted 2009-05-14 · Terminated

Recall details

Recalling firm

Draeger Medical, Inc.

Reason for recall

The device may not generate a pilot line disconnect alarm if the pilot line becomes disconnected, which may potentially result in a substantial reduction in tidal volume delivery.

Action taken

An "Urgent - Medical Device Recall" Letter dated January 2009 was issued to consignees via certified mail. The letter described the issue, specific conditions, background information, and precautions for customers. An additional letter dated January 22, 2009 was included with the "Urgent - Medical Device Recall" letter which instructed consignees to inform an enduser of the contents of the notification letter because some of the consignees are home care device/service providers. When the new hardware/software solution is available, affected devices will be updated free of charge. Direct questions about the notification letter to Drager Medical, Inc. by calling 1-800-543-5047 (press "1" at the prompt and then press "2349#"). Direct questions regarding updating your device when the new software is available, contact Drager Service Technical Support at 1-800-543-5047 (press "4" at the prompt).

Root cause

Software design

Status

Terminated

Product code

CBK

Quantity affected

40 units

Distribution

Nationwide Distribution -- states of CA, FL, GA, HI, IL, LA, MA, MN, OH, and TX.

Date initiated

2009-01-21

Date posted

2009-05-14

Date terminated

2010-01-05

Location

Telford, PA

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