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Internal Battery for Puritan Bennett 700 Series Ventilator recallZ-0444-05 · Nellcor Puritan Bennett Inc · initiated Dec 16, 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

Wires on battery may loosen causing disconnection.

FDA root cause category: Other

What the company is doing

Letters will be Fedexed to customers which includes a simple test instruction that users can use to test the performance of the back up alarm.

Recall details

Recall number
Z-0444-05
Recall class
Not yet classified by the FDA
Status
Terminated
Initiated by the company
Dec 16, 2004
Posted by the FDA
Jan 28, 2005
Recalling firm
Nellcor Puritan Bennett Inc
Quantity
6642 (3680 in vents and 2962 as replacements)
Product code
CBK
FDA submissions
K964540, K984379
Distribution
Nationwide, Europe, Japan, Latin America and other portions of Asia.

Product description

Internal Battery for Puritan Bennett 700 Series Ventilator.

Code information (models, lots, serial numbers)

All produced from 3/1/02 to 5/12/04

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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