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
The manufacturer is advising of the potential for the solera driver tips to break during use and of changes to the instructions for use to assist with this issue.
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 recalling specific lots of the sciatic nerve retractor as micropores may have formed in the hollow handle during the manufacturing process, which would be large enough to allow fluids to enter and exit the hollow handle.
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: InterMed Medical Ltd, 71 Apollo Drive, Albany, AUCKLAND 1311
Causa
There is a labelling inaccuracy in the instructions for use (ifu) and injection card. the ifu and the injection card contained within the product states that picc testing included 10 pressure injection cycles. this is not correct, it should state that catheter testing included 5 pressure injection cycles., if it were to be used for more than five (5) pressure injections, it cannot be ruled out that there is a potential risk that the catheter could rupture during injections 6-10. catheter rupture can cause catheter or air embolism, bleeding or ineffective treatment and may require the need for radiologic or surgical intervention. no customer complaints have been received for this issue.
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.
There is a risk of patient-to-patient infection if the device is not cleaned appropriately., key changes in the new instruction for use are highlighted below:, * inclusion of instruction on how to attach the cleaning adapter (maj-350) to the instrument channel port of the gf-uct180, * the balloon applicator (maj-675) and the cleaning brush (maj-1534) are to be reprocessed for reuse. the maj-675 and maj-1534 are to be reprocessed in accordance with the cleaning, disinfection, and sterilisation procedures for reusable parts and reprocessing equipment.
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
In the affected lots of the application instrument for sternal zipfix :, * the end cap may loosen, thus reducing the tension applied to the implant., * the end cap may detach, allowing the tensioning spring to also become detached, making the instrument non-functional., if the end cap is loose, the maximum tension applied to the implant is reduced and may lead to insufficient sternal bone reduction. if the tension coil spring detaches completely from the zipfix application instrument while closing the sternum, it is possible that the spring or nut could fall into the thoracic cavity and go undetected. if the nut/spring is retained in the thoracic cavity, adverse tissue reaction may occur. no such occurrence has been reported to date.
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: Global Science a Bio-Strategy Company (Bio-Strategy Limited), 241 Bush Road, Albany, Auckland 0632
Causa
Dako has determined that there is a defect in one lot of a buffer used in the manufacturing of some corresponding lots of the envision™ flex/hrp visualization reagent. specifically, some instances of moderate-to-strong non-specific staining and overly-strong specific staining have been observed when this visualization reagent was used with four antibodies against the biomarkers epstein-barr virus (ebv), mum-1, wilms' tumor1(wt1) protein and smooth muscle actin (sma). negative control antibodies in the same run were negative, and did not show the non-specific staining., , 15/01/2016: subsequent to the earlier letter the remaining dako flex ready-to use antibodies were tested using the affected envision flex/hrp visualization reagent . two additional antibodies wereidentified as having a remote potential to affect results. update overview letter sent.
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: Terumo Australia Pty Ltd (NZ), c/- Healthcare Logistics, 56 Carrington Road, Mount Albert, Auckland 1025
Causa
Terumo cardiovascular systems (terumo cvs) has become aware that under certain circumstances, a terumo® advanced perfusion system 1 centrifugal pump "service pump" message may display due to user induced motor movement., in this instance, the terumo system 1 will recognize the movement (as it is designed to do) and display a "service pump" message. the user might interpret this message as a pump that requires service rather than a message displayed due to pump movement while not activated.
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: Siemens Healthcare (NZ) Ltd, Millennium Centre, Part Level 2, Building A, 600 Great South Road, Ellerslie, AUCKLAND 1051
Causa
A possible position sensor fault in the swivel base axis not being detected by the system software may cause the c-arm system to move faster than normal when movement is enabled by the operator. the system will not move of its own accord, movement must still be initiated by the operator, however, the system can unexpectedly exceed its usual speed, potentially resulting in a collision.
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: Siemens Healthcare (NZ) Ltd, Millennium Centre, Part Level 2, Building A, 600 Great South Road, Ellerslie, AUCKLAND 1051
Causa
A possible position sensor fault in the swivel base axis not being detected by the system software may cause the c-arm system to move faster than normal when movement is enabled by the operator. the system will not move of its own accord, movement must still be initiated by the operator, however, the system can unexpectedly exceed its usual speed, potentially resulting in a collision.
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: Medifab Medical Fabrication, 32 Detroit Drive, Izone Business Hub, Rolleston 7675
Causa
The manufacturer has identified two potential issues relating to the backrest and the tilt in space locking plunger should the vehicle used to transport the end user in the discovery buggy be involved in an accident., 1/ there is potential for the s tubes to come out of the mounting block, 2/ there is potential that the discovery seat may tilt back due to the tilt in space plungers not being engaged in the plastic slides.
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
It has been determined that there is potential for sp2 im rod 400mm instruments (96-6120) manufactured with 455 stainless steel (ss) or 17-4 ss to fracture and leave a portion of the rods in patients.
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.
Specific batches of drill-hub i may not be functioning as intended (drill does not latch completely in the drill-hub i)., the upper part of the bore in the drill-hub i is slightly smaller which results in the drill not being seated correctly which means that this drill-hub will drill deeper than intended. this could lead to permanent damage of the alveolar nerve and cause permanent loss of sense in parts of the oral cavity or chin or even partial loss of speech. there is also a risk of drill loosening or not rotating as expected.
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: Siemens Healthcare (NZ) Ltd, Millennium Centre, Part Level 2, Building A, 600 Great South Road, Ellerslie, AUCKLAND 1051
Causa
Siemens healthcare diagnostics has confirmed that certain lots of alkaline phosphatase reagents used on the advia® 1200, 1650, 1800, 2400, and xpt chemistry systems demonstrate an increased incidence of absorbance flags (u, u) and //// errors. absorbance flags u and u indicate abnormal high absorbance exceeding either the blank or sample limit. absorbance flag //// indicates a calculation error and no result is generated by the system.
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.
Roche has received a number of complaints that the recovery of c-reactive protein gen. 3 (crpl3) was too high in precicontrol clinchem multi 1 (pccc1), and especially in precicontrol clinchem multi 2 (pccc2), seen mainly on the cobas c 501 module., roche diagnostics has investigated and determined that the last three reagent lots showed higher recovery for all control materials. to resolve this issue a revised target value assignment procedure was necessary., target values for currently available pccc1 and pccc2 control lots have been adjusted as per the tables given in the customer letter.
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.
Roche has received a number of complaints that the recovery of c-reactive protein gen. 3 (crpl3) was too high in precicontrol clinchem multi 1 (pccc1), and especially in precicontrol clinchem multi 2 (pccc2), seen mainly on the cobas c 501 module., roche diagnostics has investigated and determined that the last three reagent lots showed higher recovery for all control materials. to resolve this issue a revised target value assignment procedure was necessary., target values for currently available pccc1 and pccc2 control lots have been adjusted as per the tables given in the customer letter.
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.
Stryker has received two customer complaints regarding duracon tibial wedge implants puncturing the packaging's tyvek lid. in each case, the punctured tyvek lid was recognized in the operating room and a new device was opened and used.
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.
Stryker has received a customer complaint which reported that during a total hip replacement the surgeon was using the exeter small tapered pin reamer when the device fractured approximately 3 inches from the tip.
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.
Stryker has received a customer complaint which reported that during a total hip replacement the surgeon was using the exeter small tapered pin reamer when the device fractured approximately 3 inches from the tip.
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.
Stryker has received four customer complaints for v40 lfit vitallium femoral heads (manufactured 7-jul-2014 and 15-aug-2014) reporting, at the time of surgery the femoral head could not be assembled with its corresponding v40 stem trunnion. in each case a new v40 lfit vitallium femoral head was opened and used. no other adverse consequences or delays to surgery were reported for any of these complaints.
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 echnique guides for the systems mentioned above describe the pedicle awls as 4.0mm for use with screws (4.0mm - 7.0mm). these awls should be used with 5.0mm - 7.0mm screws. action is being taken to communicate changes being made to technique guides and outer labels in order to clarify the intended use of these two awls within these systems. there has been no change to the design or manufacture of the pedicle awls.
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.
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 identified the potential for damage to the wire insulation which may result in reduced or no patient therapy, arcing of current, sparking, and patient and/or clinician burns.
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.
Hospira has determined if "yes" is selected at the "new patient" screen, and the program was not cleared prior to powering off the infuser, the distal occlusion pressure setting is assigned a value of 15 psi (775 mmhg) instead of the default value. in addition, the user interface will incorrectly display the default distal occlusion pressure value, which is set at 6 psi (310 mmhg) from the manufacturer.
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: Varian Medical Systems Australasia Pty Ltd (NZ), C/- BDO Auckland - Christine Koefoed, Level 4, BDO Centre, 4 Graham Street, Auckland 1140
Causa
Admin instructions may not print on drug order prescriptions or be transmitted with e-rx. when the user changes the prescription "type" field after inputting admin instructions in the text box, the admin instructions portion of the prescription will not be saved to the database. an e-rx transmitted to the pharmacy will not contain the intended admin instructions. the printed prescription will also not contain the intended admin instructions., this anomaly only occurs for sites that have a clinical assessment license for the aria radiation oncology software/license set.
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: W M Bamford & Co Ltd, 12 Victoria Street, LOWER HUTT
Causa
Advancis medical is aware that a small number of products from specific batches may not have been fully sterilised. the manufacturer is now recalling the affected batches.