Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, 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 New Zealand.
Notas adicionales en la data
Recalling Organisation: Johnson & Johnson Medical New Zealand Ltd, 507 Mt Wellington Highway, Mt Wellington, AUCKLAND 1060
Causa
The manufacturer has determined that the sterrad 100nx sterilization system may emit an odor or smell into the surrounding environment not typical to normal operating conditions. these odors/smells do not impact sterility of the devices processed within the device.
Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, 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 New Zealand.
Notas adicionales en la data
Recalling Organisation: Alere Ltd, C/- Bell Gully, Level 22, Vero Centre, 48 Shortland Street, AUCKLAND 1010
Causa
Affected lots of this product may yield results that are not consistent with stated precision performance criteria at concentration values at the high-end range of glucose test sensor. specifically, in test cards aged to within 2.5 months (75 days) of their expiration date, a negative bias between of 15 - 30 % has been observed in sample with glucose levels greater than 22 mmol/l.
Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, 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 New Zealand.
Notas adicionales en la data
Recalling Organisation: Johnson & Johnson (NZ) Limited, 13a Gabador Place, Mt Wellington, AUCKLAND
Causa
The manufacturer is updating the instructions for use to reflect 80% suture strength at 6 weeks post implantation.
Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, 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 New Zealand.
Notas adicionales en la data
Recalling Organisation: Johnson & Johnson (NZ) Limited, 13a Gabador Place, Mt Wellington, AUCKLAND
Causa
The manufacturer is updating the instructions for use to reflect 80% suture strength at 6 weeks post implantation.
Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, 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 New Zealand.
Notas adicionales en la data
Recalling Organisation: Law and Accounting Professional Trustees Limited, 336, Jackson Street, Petone
Causa
The manufacturer has determined that the affected material sets 3 hours faster than specified in the directions for use which state a work/set time of 6 hours or greater.
Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, 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 New Zealand.
The column rotation can accidentally be moved to a different position while in the locked position. this can occur between fields. this can cause clinical mistreatment.
Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, 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 New Zealand.
Notas adicionales en la data
Recalling Organisation: Medtronic New Zealand Limited, Unit 16 Mezzanine Level, 5 Gloucester Park Road, Onehunga, AUCKLAND
Causa
Medtronic is advising users of 3 safety issues related to their insulin pumps:, 1/ potential for a loose drive support cap leading to unintended delivery of additional insulin, 2/ potential for non resumption of basal delivery when sensor graph timeout is set to "none", 3/ warning of water damage.
Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, 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 New Zealand.
In rare instances, channel shifted results have been generated with cobas® 4800 assays run on version 1.1.X of the cobas® 4800 system. raw data review indicates that, in these cases, all signals are shifted by one channel:, * channel 1 results report as channel 2,, * channel 2 results report as channel 3,, * channel 3 results report as channel 4,, * channel 4 results report as channel 1., in the reported cases the results of the runs were invalid.
Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, 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 New Zealand.
Notas adicionales en la data
Recalling Organisation: Abbott Diagnostics, 5440 Patrick Henry Drive, Santa Clara, California 95054, UNITED STATES OF AMERICA
Causa
An unsupported printer used with the m2000 instrument system may result in the following scenarios:, · an error code may be generated:, · test results may not be able to be printed in the expected format.
Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, 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 New Zealand.
Radiometer has recently become aware that patient results are displayed incorrectly in aqure when:, a) aqure is changed from the default setting for any or all parameters of international, system of units to use non international system of units (si units), and, b) the result is outside reference and critical ranges, and, c) the customer is using aqure to view the results.
Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, 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 New Zealand.
Notas adicionales en la data
Recalling Organisation: Obex Medical Ltd, 303 Manukau Road, Epsom, AUCKLAND
Causa
A review of manufacturing records has revealed that some control pumps produced at ams were released despite not meeting all final product release criteria.
Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, 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 New Zealand.
Notas adicionales en la data
Recalling Organisation: Ortho Medics Limited, 586 Great South Road, Ellerslie, Auckland 1051
Causa
There are reports that after an average usage period of seven years fatigue failure of the plastic joint may occur. the manufacturer has become aware that a joint on the spring arm may break either during use or when the spring arm is not in operation. if the joint breaks, the spring arm falls suddenly and wthout hindrance. in such a case there is a high risk of injury to the patient and other persons in the immediate vicinity.
Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, 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 New Zealand.
Notas adicionales en la data
Recalling Organisation: GE Healthcare Limited, 8 Tangihua Street, Auckland 1010
Causa
Ecg and respiration signal noise caused by dash and pdm ecg cable connector movement may result in reduced ecg, respiration and arrhythmia detection performance.
Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, 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 New Zealand.
Notas adicionales en la data
Recalling Organisation: GE Healthcare Limited, 8 Tangihua Street, Auckland 1010
Causa
Ecg and respiration signal noise caused by dash and pdm ecg cable connector movement may result in reduced ecg, respiration and arrhythmia detection performance.
Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, 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 New Zealand.
Notas adicionales en la data
Recalling Organisation: GE Healthcare Limited, 8 Tangihua Street, Auckland 1010
Causa
Ecg and respiration signal noise caused by dash and pdm ecg cable connector movement may result in reduced ecg, respiration and arrhythmia detection performance.
Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, 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 New Zealand.
ICU Medical, Inc. acquired from Pfizer in early 2017, Hospira Infusion Systems, the portion of Hospira dedicated to develop infusion pumps.
If the internal aa batteries used to power the device leak, their contents will cause damage to the device's internal components which may result in the device shutting off without issuing a warning or an audible or visual alarm. if the device shuts off it will result in a delay/interruption in therapy.
Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, 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 New Zealand.
ICU Medical, Inc. acquired from Pfizer in early 2017, Hospira Infusion Systems, the portion of Hospira dedicated to develop infusion pumps.
The proximal and distal pressure sensor calibration can drift resulting in the pump failing the proximal or distal occlusion operational test, as described in the gemstar technical service manual (tsm). a pump with this issue may, instead of reporting an error, not detect occlusions or issue false occlusion alarms, which will stop the infusion and invoke visual and audible warnings to the user.
Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, 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 New Zealand.
ICU Medical, Inc. acquired from Pfizer in early 2017, Hospira Infusion Systems, the portion of Hospira dedicated to develop infusion pumps.
A lithium battery, that is not user accessible, is used to power the memory that stores the current infusion settings and the event history logs when the pump is turned off. if the battery's voltage level drops below 2.4 volts, an 11/004 error will be displayed and the device will not be able to be used, resulting in a possible delay/interruption in therapy. additionally, the infusion settings and event history logs will be erased.
Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, 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 New Zealand.
Notas adicionales en la data
Recalling Organisation: Kimberly-Clark New Zealand, Level 1, 86 Plunket Ave, Manukau City, Auckland
Causa
Investigation has identified that some individual container filter units from product lots as listed might contain thin layers that may potentially compromise the ability of the filter to maintain a sterile barrier. the risk associated with this potential failure mode is that use of an affcetd filter could result in possible contaimination of surgical instruments and supplier within the container.
Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, 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 New Zealand.
Following reports of a patient death and injury reports associated with this device, stryker had developed new warnings and labelling to be affixed to the neptune 1 silver and the neptune 2 ultra to remind customers of the steps they need to take to continue using these devices. additional user training is also being provided.
Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, 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 New Zealand.
Following reports of a patient death and injury reports associated with this device, stryker had developed new warnings and labelling to be affixed to the neptune 1 silver and the neptune 2 ultra to remind customers of the steps they need to take to continue using these devices. additional user training is also being provided.
Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, 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 New Zealand.
The manufacturer has advised that during the production process of the d-dimer test kits a chemical reagent has been missed in a small number of test cups.
Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, 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 New Zealand.
ICU Medical, Inc. acquired from Pfizer in early 2017, Hospira Infusion Systems, the portion of Hospira dedicated to develop infusion pumps.
During infusions at flow rates of 1ml/hr or less, the motor assembly may rotate backwards (roll-back), capturing additional medication that will be delivered resulting in over-infusion. additionally, users may receive x09/001 backward motor movement alarms during the device's power on self test (post) or during an infusion. this alarm will invoke visual and audible warnings to the user and the infusion will not begin or stop, resulting in a delay or interruption in therapy.
Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, 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 New Zealand.
The manufacturer is reminding users that the battery charger should be replaced every 2 years, and that the battery condition checked on a regular basis.
Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, 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 New Zealand.
The manufacturer advises the labels applied to the specified lots may no accurately reflect the size of the product contained in the packaging. the correct sizing is mouled into each pessary.