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Model 740 and 760 series Ventilators recallZ-0445-05 · Nellcor Puritan Bennett Inc · initiated Dec 17, 2004

Terminated All recalls posted in January 2005

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Nellcor Puritan Bennett Inc or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

Capacitor weakness in backup alarm system might fail causing lack of backup alarm to function in the event of total power loss.

FDA root cause category: Other

What the company is doing

Customers of record will be notified by letter sent FEDEX, a simple test instruction will be included to use to test the performance of the backup alarm.

Recall details

Recall number
Z-0445-05
Recall class
Not yet classified by the FDA
Status
Terminated
Initiated by the company
Dec 17, 2004
Posted by the FDA
Jan 28, 2005
Recalling firm
Nellcor Puritan Bennett Inc
Quantity
13,010 worldwide, 3,948 in USA and territories.
Product code
CBK
FDA submissions
K964540, K984379
Distribution
Worldwide.

Product description

Model 740 and 760 series Ventilators.

Code information (models, lots, serial numbers)

All units ever manufactured. The product may be identified and tracked through serial numbers. This is a tracked device.

Other devices under the same FDA submission

1 device cleared under K964540, K984379 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Sources and updates

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