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FDA Medical Device Recalls (openFDA)

Puritan Bennett: Puritan Bennett 840 Series Ventilator Power Supply Model/Catalog Numbers: 4-076314-00; 4-076314-SP

Recall number
Z-1085-05
Recalling firm
Puritan Bennett
Product
Puritan Bennett 840 Series Ventilator Power Supply Model/Catalog Numbers: 4-076314-00; 4-076314-SP
Status
Terminated
Initiated
2005-04-20
Posted
2005-08-06
Terminated
2012-01-25
Reason
Manufacturing defect at contract manufacturer, employee error, poor training, improper inspection.
Root cause
Other
Action
Recall is by letter sent Fedex 4/20/05. After two weeks nonrespondants will be telephoned. Foreign customers will be handled by firm''s local offices similarly.
Quantity
309
Distribution
USA, Canada and Europe.
Lot, serial or model codes
All codes
510(k) numbers
["K970460"]
PMA numbers
not on file
Product code
CBK
Firm FEI
3001609256
Firm city
Pleasanton
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

Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.

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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