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U.S. Department of Health and Human Services

Medical Device Recalls

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API ZYM Bx2 (Ref 70493) Product Usage: ZYM B reagent is an additional test used for revealing th... 2 Feb-04-2016 BioMerieux SA
BacT/ALERT® FA, bioM®rieux, Inc., Product Usage: BacT/ALERT® Culture Bottles are used with the B... 2 Feb-04-2016 bioMerieux, Inc.
ADVIA Centaur PSA Assay; Catalog Number: 06574155/SMN 10310292 (100 test kit) and Catalog Number: 02... 2 Feb-04-2016 Siemens Healthcare Diagnostics, Inc
ADVIA Chemistry XPT Systems, Software Version 1.0.3, SMN 11127538 Clinical chemistry analyzer tha... 2 Feb-04-2016 Siemens Healthcare Diagnostics, Inc.
BacT/ALERT® SN, bioM®rieux, Inc. Product Usage: BacT/ALERT® Culture Bottles are used with the Ba... 2 Feb-04-2016 bioMerieux, Inc.
Astral 100, 150 Model: 27001, 27003 In the US, Astral devices are primarily used as non-invasive h... 2 Feb-03-2016 Resmed Corporation
ET-20 Anesthesia Extension Tubes, 2.5 ml approximately, Sterile and Disposable, Wall Medical Inc., 4... 2 Feb-03-2016 Global Healthcare Inc
Synthes Small Electric Drive (SED). For use in general traumatology. 2 Feb-03-2016 The Anspach Effort, Inc.
Emergency Transport Ventilator Oxylog 3000 Ventilator and Oxylog 3000 plus Ventilator Catalog Numb... 1 Feb-03-2016 Draeger Medical, Inc.
AQURE System; Model Number: 933-599. The AQURE System manages blood gas and immunoassay analyzers. 2 Feb-03-2016 Radiometer America Inc

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