Canadian data is current through March 2018. All of the data comes from Health Canada, 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 Canada.
Notas adicionales en la data
Causa
Higher than normal number of false negative tests for anti-fya. potentially implicated in transfusion reaction. see incident 019978.
Canadian data is current through March 2018. All of the data comes from Health Canada, 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 Canada.
Notas adicionales en la data
Causa
Defects may occur during the manufacturing of trima accel tubing sets. it was found during assembly of the ac/draw/return manifold the automated equipment may improperly insert the return line tubing into the manifold in such a way that the tubing maybe bent.
Canadian data is current through March 2018. All of the data comes from Health Canada, 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 Canada.
Notas adicionales en la data
Causa
A leak has been found at the shank during priming before perfusion a manufacturer issue was detected at the supplier level.
Canadian data is current through March 2018. All of the data comes from Health Canada, 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 Canada.
Notas adicionales en la data
Causa
Stryker has become aware that there is a remote likelihood of incomplete welds on the drop tube flange of the visum 300 ceiling-mounted exam light.
Canadian data is current through March 2018. All of the data comes from Health Canada, 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 Canada.
Canadian data is current through March 2018. All of the data comes from Health Canada, 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 Canada.
Notas adicionales en la data
Causa
The devices being recalled are surgical clip appliers that are preloaded for use in minimally invasive surgical procedures. teleflex is recalling these devices because they have a nonconformity that may cause clips to misload jam or fall out of the appliers.
Canadian data is current through March 2018. All of the data comes from Health Canada, 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 Canada.
Notas adicionales en la data
Causa
Zimmer is initiating a device correction for the trinica anterior lumbar plate (alp) system case assembly. the ratchet handles part number 07.00438.001 may not be effectively sterilized if left in their designated location(s) in the instrument tray. this is due to the current bracketing in the tray which may interfere with complete steam penetration into the cannulated handle. to assure effective sterilization the ratchet handles must be sterilized external to the instrument tray until newly designed replacement trays are available.
Canadian data is current through March 2018. All of the data comes from Health Canada, 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 Canada.
Canadian data is current through March 2018. All of the data comes from Health Canada, 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 Canada.
Notas adicionales en la data
Causa
Abg kits outer labels incorrectly identified as containing 200 units of heparin when in fact the 3cc syringe only contains 100 units.
Canadian data is current through March 2018. All of the data comes from Health Canada, 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 Canada.
Notas adicionales en la data
Causa
The wedge mu is correct after the first treatment at the non-varian machine however after treatment varis may prompt to save and the wedge mu is reset to null for sebsequent sessions.
Canadian data is current through March 2018. All of the data comes from Health Canada, 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 Canada.
Notas adicionales en la data
Causa
Leak through the pinch/line clamp following insertion. the clamp may not occlude for the three product lines.
Canadian data is current through March 2018. All of the data comes from Health Canada, 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 Canada.
Notas adicionales en la data
Causa
Les valeurs de l'isi publiees dans la notice technique des lots concernes de simplastin excel s sont inexactes pour les instruments fibrometre (mecanique) option xm et mtx (photo optique).
Canadian data is current through March 2018. All of the data comes from Health Canada, 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 Canada.
Notas adicionales en la data
Causa
Through monitoring of method performance siemens has determined that the analytical sensitivity claim of 6.6 mcg/dl (1.1 mcmol/l) stated in the instructions for use is no longer valid for dimension total iron binding capacity (ibct) and is modifying that claim to 36 mcg/dl (6.44 mcmol/l).
Canadian data is current through March 2018. All of the data comes from Health Canada, 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 Canada.
Notas adicionales en la data
Causa
Siemens healthcare diagnostics has confirmed a lot to lot bias with calibrator e kit for the advia centaur testosterone assay. internal investigation demonstrates: -an average positive bias of 17% across the assay range with calibrator e kit lots ending in 42 as compared to values generated with the master curve. -an average negative bias of 7% across the assay range with calibrator e kit lots ending in 43 as compared to values generated with the master curve. -the positive bias of calibrator e kit lots ending in 42 to the master curve compared to the negative bias of calibrator e kit lots ending in 43 to the master curve is the main driver for the negative bias between values generated with calibrator e kit lots ending in 42 and calibrator e kit lots ending in 43. the bias of the calibrators to the master curve has been corrected with calibrator e kit lots ending in 44. the performance of the testosterone assay on the advia centaur cp is not affected. calibrator e is also used for calibration of the advia centaur systems cortisol and progesterone assays however the performance of these assays is not affected.
Canadian data is current through March 2018. All of the data comes from Health Canada, 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 Canada.
Canadian data is current through March 2018. All of the data comes from Health Canada, 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 Canada.
Notas adicionales en la data
Causa
Penumbra has become aware of complaints involving devices where the operator complained of damage to the tip of the neuron max mp catheter after removal from the packaging. upon evaluation of the returned devices penumbra confirmed that the polymer at the distal tip of the device had been damaged. further investigation determined that the sticker adhesive used to secure the packaging mandrel to the packaging card was less sticky then previous lots of stickers.
Canadian data is current through March 2018. All of the data comes from Health Canada, 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 Canada.
Notas adicionales en la data
Causa
An internal investigation identified a performance deviation associated with quality control testing of retained product samples indeed the qc results were out of range resulting in false resistant strains.
Canadian data is current through March 2018. All of the data comes from Health Canada, 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 Canada.
Notas adicionales en la data
Causa
A limited number of tubes may be mislabelled on the blue bronchial sleeve. the label may incorrectly state "right" when it should state "left" or "left" when it should state "right".
Canadian data is current through March 2018. All of the data comes from Health Canada, 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 Canada.
Notas adicionales en la data
Causa
The urology catheters are being recalled because the packaging may be compromised and therefore the sterility of the product cannot be guaranteed.