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FDA Medical Device Recalls (openFDA)

Biosense Webster, Inc.: Quickcable Autoclaveable Cable Electrode Cable

Recall number
Z-1006-04
Recalling firm
Biosense Webster, Inc.
Product
Quickcable Autoclaveable Cable Electrode Cable
Status
Terminated
Initiated
2004-05-21
Posted
2004-07-20
Terminated
2005-03-31
Reason
Mislabeling.
Root cause
Other
Action
Recall was by letter on May 21, 2004 requesting return of affected lot.
Quantity
212
Distribution
Nationwide, Australia, Korea, Chile, Brazil.
Lot, serial or model codes
Lot 005955
510(k) numbers
not on file
PMA numbers
not on file
Product code
DRF
Firm FEI
3003113629
Firm city
Irwindale
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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