117 results
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27ms
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Sources: EU EUDAMED, US FDA
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FDA Recall
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Pyxis Anesthesia System Model 2000 (PAS 2000) Product Usage: The PAS 2000 is an anesthesia medication dispensing device that provides medications and inventory management for the anesthesiologist at the point of care within the operating room.
FDA Recall
Terminated
·CareFusion Corporation·Product code BRY·November 20, 2009
PAS-PORT PROXIMAL ANASTOMOSIS SYSTEM Catalog Number: FC700SU
FDA Recall
Terminated
·Aesculap Implant Systems LLC·Product code FZP·April 16, 2021
PAS-PORT PROXIMAL ANASTOMOSIS DEVICE US Catalog Number: FG-000001-13
FDA Recall
Terminated
·Aesculap Implant Systems LLC·Product code FZP·April 16, 2021
Codan Filter (Codan catalog number BC 693) used with Medrad Patient Administration Sets (PAS) and Intego PET Infusion Systems Product Usage: 1.2 micron filter for use with Intravenous Administration Sets
FDA Recall
Terminated
·Bayer Medical Care, Inc.·Product code FPA·September 7, 2018
Physiological Monitoring, Patient Monitor M31250 Information Center Local Database Releases A, B, E.01, G, H, J, K, L, & M of Philips IntelliVue Information Center Software used in conjunction with PAS-210 Kit Remote Active Speakers. The intended use of the Information Center Software is to display physiologic waves, parameters and trends, formal data for strip recordings and printed reports and provide the secondary annunciation of alarms from other networked medical devices at a centralized location. The Information Center Software provides for the retrospective review of alarms, physiologic waves and parameters from its database. An additional intended use is to provide primary annunciation of alarms and configuration and control access for networked telemetry monitors.
FDA Recall
Terminated
·Philips Healthcare Inc.·Product code MHX·December 17, 2010
Philips Audio-Video Engineering PAS-210 Remote Active Speakers Kit used with the IntelliVue Information Center The intended use of the Information Center Software is to display physiologic waves, parameters and trends, formal data for strip recordings and printed reports and provide the secondary annunciation of alarms from other networked medical devices at a centralized location. The Information Center Software provides for the retrospective review of alarms, physiologic waves and parameters from its database. An additional intended use is to provide primary annunciation of alarms and configuration and control access for networked telemetry monitors.
FDA Recall
Terminated
·Philips Healthcare Inc.·Product code MHX·May 3, 2011
Centurion scalpel handle kits labeled as: a) STERILE # 3 SCALPEL HANDLE, Product Code 66825; b) STERILE PAS #3 BLADE HANDLE (BH3PAS), Product Code I68290
FDA Recall
Open, Classified
·MEDLINE INDUSTRIES, LP Northfield·Product code GDZ·February 23, 2024
BD Pyxis Anesthesia ES System (PAS ES), REF: 327; BP Pyxis MedStation ES (Med ES Main), REF: 323; BD Pyxis MedStation ES Tower (Med ES Tower), REF: 352; all with BD Pyxis ES version 1.6.1 drawer firmware (version 1.10.2.5). Pyxis MedStation Enterprise Server (ES) System is an automated medication dispensing system supporting decentralized medication management in a pharmaceutical environment.
FDA Recall
Open, Classified
·CareFusion 303, Inc.·Product code BRY·February 14, 2023
(1) Pyxis MedStation ES, Catalog No. 323; (2) Pyxis Anesthesia Station (PAS), Catalog No. 327; (3) Pyxis MedStation ES Tower, Catalog No. 352; (4) BD Pyxis CII Safe ES, Catalog No. 1116-00
FDA Recall
Open, Classified
·CareFusion 303, Inc.·Product code BRY·January 8, 2025
Histochemical PAS (Periodic Acid Schiff) Reaction Set. in vitro diagnostic. Product size configuration: Set of 4 bottles including Schiff Reagent 225mL, Light Green SF Yellowish Stain 225mL, Sodium Carbonate Solution 225mL, and Periodic Acid Solution 225mL. Each kit provides reagents sufficient for a maximum of 100 tests.
FDA Recall
Terminated
·EMD Chemicals Inc·Product code KKS·July 25, 2006
Histochemical PAS (Periodic Acid Schiff) Reaction Set' Class I, IVD; Set of 4 bottles including Schiff Reagent 225 mL, Light Green SF Yellowish Stain 225 mL, Sodium Carbonate Solution 225 mL and Periodic Acid Solution 225 mL' EMD Chemicals, Inc. 480 S. Democrat Road, Gibbstown, NJ 08027 Each kit provides reagents sufficient for a maximum of 100 tests.
FDA Recall
Terminated
·EMD Chemicals Inc·Product code HZT·June 2, 2008
(1) BD Pyxis MedStation ES, Catalog No. 323; (2) BD Pyxis Anesthesia Station (PAS), Catalog No. 327; (3) BD Pyxis MedStation ES Tower, Catalog No. 352; (4) BD Pyxis MedStation 4000 Console, Catalog No. 309; (5) BD Pyxis MedStation 4000, Catalog No. 303; (6) BD Pyxis Anesthesia System 4000, Catalog No. 338
FDA Recall
Open, Classified
·CareFusion 303, Inc.·Product code BRY·January 8, 2025
BD MicrotainerTubes with K2E (K2EDTA) Catalog Number: 365974
FDA Recall
Terminated
·Becton Dickinson & Company·Product code JKA·May 13, 2019
BD Microtainer Tubes with LH (Lithium Heparin) Part/Catalog No.365965
FDA Recall
Terminated
·Becton Dickinson & Company·Product code JKA·May 13, 2019
BD Microtainer Z (No Additive Tubes) Part/Catalog No.365963
FDA Recall
Terminated
·Becton Dickinson & Company·Product code JKA·May 13, 2019
BD Microtainer PSTTubes with LH (Lithium Heparin) Part/Catalog Number:365985
FDA Recall
Terminated
·Becton Dickinson & Company·Product code JKA·May 13, 2019
BD Microtainer PST Tubewith LH (Lithium Heparin) - Amber Part/Catalog Number: 365987
FDA Recall
Terminated
·Becton Dickinson & Company·Product code JKA·May 13, 2019
BD Microtainer SST Part/Catalog No.365967
FDA Recall
Terminated
·Becton Dickinson & Company·Product code JKA·May 13, 2019
BD Microtainer SST- Amber Part/Catalog Number: 365978
FDA Recall
Terminated
·Becton Dickinson & Company·Product code JKA·May 13, 2019
The device's marketing brochure states: "IntelliVue M3150 Information Center...Philips Medical Systems". The beige-colored PAS-210 external speakers can be identified by their use of DB15-to-3.5 mm mini-phone jack cable (Agispec-081Y-4 or Agispec-081-6) to connect to the rp5700 PC. Indicated for central monitoring of multiple adult, pediatric, and neonatal patients.
FDA Recall
Terminated
·Philips Medical Systems North America Co. Phillips·Product code DSI·November 21, 2008