FDA Medical Device Recalls (openFDA)
Sendx Medical Inc: ABL77 Cal Pack, Model Number 944-069, Lot Number 17323, SenDx Medical Inc., A Radiometer Company
- Recall number
- Z-1173-2007
- Recalling firm
- Sendx Medical Inc
- Product
- ABL77 Cal Pack, Model Number 944-069, Lot Number 17323, SenDx Medical Inc., A Radiometer Company
- Status
- Terminated
- Initiated
- 2007-06-19
- Posted
- 2007-08-18
- Terminated
- 2011-11-07
- Reason
- Error in the Ca12 calibration value for pCO2 recorded in the cal pack barcode for lot 17323. This error will result in falsely elevated pCO2 results at the high end of the measuring range.
- Root cause
- Other
- Action
- A total of four (4) distributors were sent the recall package (Field Action Notice) by email on 6-29-07. The distributors were provided background information and specific instruction that all Cal packs from lot 17323 should be removed from customer sites and destroyed. The Recall package included a Management Cover for Field Action Notes, a Customer Letter and the Field Action Notice #915-261. All communications regarding field actions associated with this recall were distributed using the Radiometer Field Action Note (FAN) system.
- Quantity
- 69
- Distribution
- Worldwide Distribution --- USA including state of OH and countries of China, Denmark Latvia, Mexico & Spain.
- Lot, serial or model codes
- Lot Number 17323
- 510(k) numbers
- ["K994346"]
- PMA numbers
- not on file
- Product code
- CHL
- Firm FEI
- 2027541
- 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
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