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.
Notas adicionales en la data
RECALL: ETHILON. Suture, ETHIBOND. and MERSILENE. Polyester Fiber SUTURES and MERSILK. SUTURES, MULTIPLE LOTS1. 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.
Notas adicionales en la data
RECALL: Medtronic CoreValve Delivery System (DCS) Model:- DCS-C3-18FR or DCS-C4-18FR1. 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.
Notas adicionales en la data
MDB/R/2008/006 - Surgical Blades manufactured by ConMed Linvatec Hall, in blister packaging - single use device. Holes have been discovered in the corners of the blister packaging for these devices. This may compromise the sterility of the device and lead to the possibility of infection.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.
Notas adicionales en la data
RECALL: Symbiq One-Channel Infuser and Symbiq Two-Channel Infuser1. Letter from MDB 2. Letter from Hospira
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.
Notas adicionales en la data
RECALL: BD Microlance 30G x Needle by Becton Dickinson & Co.1. Letter from MDB
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.
Notas adicionales en la data
RECALL: JOHNSON & JOHNSON 1•DAY ACUVUE® TRUEYETM BRAND CONTACT LENSES1. 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.
Notas adicionales en la data
MDB/R/2008/005 - IntraStent Unmounted Balloon Expandable Stent. The manufacturer has advised the Irish Medicines Board of a recall of specific lots of the IntraSrent Unmounted Balloon Expandable Stent.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.
Notas adicionales en la data
MDB/R/2008/008 - Robertshaw endotracheal tubes (PVC, disposable) all sizes - manufactured by Phoenix Medical, a P3 Medical Ltd company. Due to a manufacturing defect there is a risk of damage to the intubating stylet on its removal from the endotracheal tube. 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.
Notas adicionales en la data
MDB/R/2008/001 - Implantable Cardioverter Defibrillator (ICD) lead. Sprint Fidelis manufactured by Medtronic. ICD lead recall due to risk of inappropriate patient shocks, loss of defibrillation therapy and/or loss of pacing output, caused by fracture of the lead conductor.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.
Notas adicionales en la data
Recall : Voluntary Recall Of Durex Real Feel Batch1. Letter from MDB
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.
Notas adicionales en la data
RECALL: Exel Huber Needles, Exel Huber Infusion Sets, and Exel "SecureTouch+" Safety Huber Infusion 1. Letter from MDB 2. Reference
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.
Notas adicionales en la data
MDB/R/2008/010 - A limited number of electrosurgical blades and needles may have an inadequate packaging seal, potentially compromising the sterility of the device.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.
Notas adicionales en la data
RECALL: Arrow Ultra 8 Intra-Aortic Balloon Catheters (IABS) 8 FR 30CC and 40CC Universal and Arrow Intra-Aortic Balloon (IAB) Catheter with a Fiber Optic Sensor and Measurement System.1. Letter from MDB 2. Letter from Arrow [Page 1 ] [Page 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.
Notas adicionales en la data
RECALL: Voluntary Recall of Clear & Simple Digital Pregnancy Test 1. Letter from MDB.
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.
Notas adicionales en la data
MDB/R/2008/009 - Small number of SynchroMed II infusion pumps may have been manufactured without propellant, according to report. 8 SynchroMed II pump have been returned to Medtronic and confirmed to have a missing propellant.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.
Notas adicionales en la data
MDB/A/2008/006 - Reports received from users stating that the Sterrad Sterilisers emitting a mist due to a premature mechanical failure in its oil mist filter and/or filter assemblies.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.
Notas adicionales en la data
ALERT: Fisher & Paykel Healthcare SleepStyle Series CPAP – Power Cord1. Letter from MDB 2. Letter from Fisher & Paykel 1 3. Letter from Fisher & Paykel 2 4. Letter from Fisher & Paykel3
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.
Notas adicionales en la data
ALERT : Polydent Denture Adhesive Cream1. Letter from MDB 2. Letter from GlaxoSmithKline
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.
Notas adicionales en la data
MDB/A/2008/002 - H-1200 Fast Fluid Warmer with integrated Air Detector/Clamp and H-31B and H-30 Air Detector/Clamp Accessory. The risk of air embolism if the power of the fluid warmer unit is interrupted either manually or through power failure during an air detection event.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.
Notas adicionales en la data
MDB/A/2008/011 - Maximo II ICD, DR ICD and CRT-D by Medtronics. The company is notifying customers that some of the above mentioned models have a configuration issue.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.
Notas adicionales en la data
ALERT: All TomoTherapy Hi-ART Treatment Systems – operating on Version 4.0.0, 4.0.1 and 4.0.2 software1. Letter from MDB 2. TomoTherapy Notice 1 3. TomoTherapy Notice 2 4. TomoTherapy Notice 3 5. TomoTherapy Notice 4
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.
Notas adicionales en la data
ALERT: Thoratec Heartmate II Left Ventricular Assist System (HM II LVAS) System Controllers1. Letter from MDB 2. Letter from THORATEC
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.
Notas adicionales en la data
MDB/A/2008/012 - Prostiva RF Model 8929 Hand Piece Device - field corrective action letter dated 4 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.
Notas adicionales en la data
MDB/A/2008/008 - Baxter Colleague Triple Channel Mono, CX and CXE Volumetric Infusion Pumps - upgrading of software. Users of the abovementioned device should contact the distributor/supplier of this device.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.
Notas adicionales en la data
MDB/A/2008/009 - Procedure packs from various manufacturers which contain BD Medical Surgical Syatems 2ml, 5ml, and 10ml Plastipak Luer Slip syringes. Potential for the BD Luer slip syringes supplied in procedure packs to spontaneously disconnect or fail to maintain a secure connection to Luer fittings of other devices.Read more.