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FDA Medical Device Recalls (openFDA)

Nellcor Puritan Bennett Inc: Internal Battery for Puritan Bennett 700 Series Ventilator.

Recall number
Z-0444-05
Recalling firm
Nellcor Puritan Bennett Inc
Product
Internal Battery for Puritan Bennett 700 Series Ventilator.
Status
Terminated
Initiated
2004-12-16
Posted
2005-01-28
Terminated
2008-01-23
Reason
Wires on battery may loosen causing disconnection.
Root cause
Other
Action
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.
Quantity
6642 (3680 in vents and 2962 as replacements)
Distribution
Nationwide, Europe, Japan, Latin America and other portions of Asia.
Lot, serial or model codes
All produced from 3/1/02 to 5/12/04
510(k) numbers
["K964540","K984379"]
PMA numbers
not on file
Product code
CBK
Firm FEI
3002658105
Firm city
Carlsbad
Firm state
CA
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

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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

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