FDA Medical Device Recalls (openFDA)
Radiometer America Inc: D711, Reference Membranes, Part #942-058, used with the ABL835 Blood Gas Analyzers.
- Recall number
- Z-1319-06
- Recalling firm
- Radiometer America Inc
- Product
- D711, Reference Membranes, Part #942-058, used with the ABL835 Blood Gas Analyzers.
- Status
- Terminated
- Initiated
- 2005-06-17
- Posted
- 2006-08-02
- Terminated
- 2011-09-14
- Reason
- The recalled membranes cause the status value of the pH and electrolyte electrodes to be offset causing readings outside of the acceptable range.
- Root cause
- Other
- Action
- The recalling firm notified their distributor/customers of this recall, via telephone on 6/17/2005, at which time, the customers were asked to destroy any and all suspect reference membranes found on-site and at their subaccount customer locations.
- Quantity
- 13 boxes/4 membranes per box
- Distribution
- Nationwide, including TX, OK, MI, CO, NY, and Canada.
- Lot, serial or model codes
- Lot Code: R0308, Expiration Date: 4/07; Lot Code: R0309, Expiration Date: 5/07; and Lot Code: R0310, Expiration Date: 5/07.
- 510(k) numbers
- ["K041874"]
- PMA numbers
- not on file
- Product code
- CHL
- Firm FEI
- 1523456
- Firm city
- Westlake
- Firm state
- OH
- 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