Malaysian data is current through October 2018. All of the data comes from the Ministry of Health Malaysia, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Malaysia.

ALERT- PRODUCT CORRECTIONProduct: spesific STERRAD 50 SterilizerRead More:1. Alert Letter from MDB2. Johnson & Johnson's Letter to MDB 3. Johnson & Johnson's Customer Notification Letter

Malaysian data is current through October 2018. All of the data comes from the Ministry of Health Malaysia, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Malaysia.

ALERT: MEDTRONICS Dual Chambers Pacemaker1. Letter from MDB 2. Letter from Medtronic

Malaysian data is current through October 2018. All of the data comes from the Ministry of Health Malaysia, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Malaysia.

ALERT: Thermo Fisher Scientific’s – THERMO SCIENTIFIC HM355S-31. Letter from MDCD 2. Direct Customer letter 3. Distributor letter 4. FSCA MY 5. Unit list-HM355S

Malaysian data is current through October 2018. All of the data comes from the Ministry of Health Malaysia, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Malaysia.

MDB/A/2008/007 -  Gambro has identified the potential for a total or partial occlusion of the arterial (red) and/or venous (blue) dialyser connectors of these blood tubing sets.   This is due to a moulding defect.Read more.

Malaysian data is current through October 2018. All of the data comes from the Ministry of Health Malaysia, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Malaysia.

ALERT: Limited number of LIFEPAK 15 Monitor/Defibrillator1. Letter from MDB 2. Letter from Medtronic

Malaysian data is current through October 2018. All of the data comes from the Ministry of Health Malaysia, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Malaysia.

ALERT: MODEL 5388 DUAL CHAMBER EXTERNAL TEMPORARY PULSE GENERATOR1. Letter from MDB 2. Letter from Medtronic

Malaysian data is current through October 2018. All of the data comes from the Ministry of Health Malaysia, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Malaysia.

Alert: Omnifuse and Omnifuse PCA Syringe Pumps (“Omnifuse Pumps”)1. Letter from MDB 2. Customer Information Bulletin 2015 3. Field Safety Notice 4. MEDDEV FSCA Report Form 5. Response Form 6. Risk Review Analysis Summary

Malaysian data is current through October 2018. All of the data comes from the Ministry of Health Malaysia, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Malaysia.

ALERT: CONSULTA CRT-D, SECURA DR/VR, CONCERTO II CRT-D, VIRTUOSO II DR/VR, MAXIMO II CRT-D, MAXIMO I1. MDB Alert2. Letter from Medtronic

Malaysian data is current through October 2018. All of the data comes from the Ministry of Health Malaysia, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Malaysia.

ALERT : Baxter Infusor - Product Codes: 2C1008KP, 2C1009KP - Multiple lots affected.1. MDB Alert Letter2. Baxter's Letter3. Product Brochure

Malaysian data is current through October 2018. All of the data comes from the Ministry of Health Malaysia, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Malaysia.

MDB/A/2008/013  -  Deep Brain Stimulation Lead Kits Model 3387, 3387S, 3389 and 3389S DBS Lead Kits.  Field Corrective Action letter dated 15 August 2008 from Medtronic International Ltd.Read more.

Malaysian data is current through October 2018. All of the data comes from the Ministry of Health Malaysia, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Malaysia.

ALERT: LIFEPAK 20 AND LIFEPAK 20e DEFIBRILLATORS/MONITORS1. MDB's Alert 2. Letter form Medtronic

Malaysian data is current through October 2018. All of the data comes from the Ministry of Health Malaysia, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Malaysia.

ALERT: EnRhythm Pacemakers1. Letter from MDB 2.  Letter from Medtronic International

Malaysian data is current through October 2018. All of the data comes from the Ministry of Health Malaysia, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Malaysia.

ALERT: HomeChoice Automated PD System and HomeChoice PRO Automated PD SystemProduct Codes: 5C4474 and R5C83201. Letter from MDB 2. Letter from Baxter 1 3. Letter from Baxter 2

Malaysian data is current through October 2018. All of the data comes from the Ministry of Health Malaysia, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Malaysia.

ALERT: CORDIS Cypher Select + Sirolimus-eluting Coronary Stent.1. Letter from MDB 2. Letter from Johnson & Johnson

Malaysian data is current through October 2018. All of the data comes from the Ministry of Health Malaysia, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Malaysia.

MDB/A/2008/003 - Homechoice / Homechoice Pro Automated Peritoneal Dialysis System - current software versions by Baxter Internationals.  The company has received a report of dehydration occurring in a pediatric patient, where patient received incorrect amount of dextrose (with different concentration).Read more.

Malaysian data is current through October 2018. All of the data comes from the Ministry of Health Malaysia, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Malaysia.

ALERT: NIKKISO AQUARIUS SYSTEM – MACHINE’S WHEEL –  AQUARIUS HEMOFILTRATION DEVICE1. Letter from MDB 2. Letter from Nikkiso 3. Letter from Baxter to Medical Device Control Division 4. Letter from Baxter

Malaysian data is current through October 2018. All of the data comes from the Ministry of Health Malaysia, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Malaysia.

MDB/A/2008/001 - Hospira butterfly winged needle infusion set  -  regular and intermittent.  All batches manufactured prior to April 2008. Read more.

Malaysian data is current through October 2018. All of the data comes from the Ministry of Health Malaysia, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Malaysia.

ALERT : All TomoTherapy Hi-ART Systems – with Version 3.x and 4.0.x software1. Letter from MDB 2. Letter from TomoTherapy [LETTER 1 ]  [LETTER 2 ]  [LETTER 3 ]

Malaysian data is current through October 2018. All of the data comes from the Ministry of Health Malaysia, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Malaysia.

MDB/A/2008/005 - Invasive blood pressure monitoring sets: LogiCal, NovaTrans and TransStar models with trigger flush device.  These devices are disposable blood pressure monitoring sets with a trigger flush device to maintain patency of the line during invasive pressure monitoring.Read more.

Malaysian data is current through October 2018. All of the data comes from the Ministry of Health Malaysia, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Malaysia.

ALERT: All TomoDirect Delivery licensed systems1. Letter from MDB 2.TomoTherapy Inc

Malaysian data is current through October 2018. All of the data comes from the Ministry of Health Malaysia, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Malaysia.

MDB/A/2008/004 - Lifepak 12 and Lifepak 20/20e Defibrillators/Monitors by Medtronics.  Field corrective action due to some of the above models have a potential to incorrectly render a shock or no shock decision during automated external defibrillators (AED) analysis.Read more.

Malaysian data is current through October 2018. All of the data comes from the Ministry of Health Malaysia, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Malaysia.

MDB/A/2008/010  -  Smiths Medical Graseby Omnifuse and Omnifuse PCA syringe pumps.  Possibility of patients being given an additional / unnecessary infusion when syringes are changed or infusion restarted when using DrugPro software.Read more.

Malaysian data is current through October 2018. All of the data comes from the Ministry of Health Malaysia, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Malaysia.

ALERT: Discolouration and Haemolysis of 0.8% RRBCproducts: (certain number of products within the indicated batch)- not all kits are affected.Abtectcell III 0.8%Phenocell C 0.8%1. Letter from MDB 2. Letter from CSL [Page 1 ] [Page 2 ]