U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Due to a manufacturing error after autoclaving the tubular retractor coating, physical vapor deposition (pvd) black titanium nitride (tin), may rub off.
Acción
The firm sent out a recall letter dated January 25, 2006 stating the problem and requesting the return of all unused product.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Due to a manufacturing error after autoclaving the tubular retractor coating, physical vapor deposition (pvd) black titanium nitride (tin), may rub off.
Acción
The firm sent out a recall letter dated January 25, 2006 stating the problem and requesting the return of all unused product.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Due to a manufacturing error after autoclaving the tubular retractor coating, physical vapor deposition (pvd) black titanium nitride (tin), may rub off.
Acción
The firm sent out a recall letter dated January 25, 2006 stating the problem and requesting the return of all unused product.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Due to a manufacturing error after autoclaving the tubular retractor coating, physical vapor deposition (pvd) black titanium nitride (tin), may rub off.
Acción
The firm sent out a recall letter dated January 25, 2006 stating the problem and requesting the return of all unused product.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Due to a manufacturing error after autoclaving the tubular retractor coating, physical vapor deposition (pvd) black titanium nitride (tin), may rub off.
Acción
The firm sent out a recall letter dated January 25, 2006 stating the problem and requesting the return of all unused product.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Due to a manufacturing error after autoclaving the tubular retractor coating, physical vapor deposition (pvd) black titanium nitride (tin), may rub off.
Acción
The firm sent out a recall letter dated January 25, 2006 stating the problem and requesting the return of all unused product.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Due to a manufacturing error after autoclaving the tubular retractor coating, physical vapor deposition (pvd) black titanium nitride (tin), may rub off.
Acción
The firm sent out a recall letter dated January 25, 2006 stating the problem and requesting the return of all unused product.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Due to a manufacturing error after autoclaving the tubular retractor coating, physical vapor deposition (pvd) black titanium nitride (tin), may rub off.
Acción
The firm sent out a recall letter dated January 25, 2006 stating the problem and requesting the return of all unused product.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Due to a manufacturing error after autoclaving the tubular retractor coating, physical vapor deposition (pvd) black titanium nitride (tin), may rub off.
Acción
The firm sent out a recall letter dated January 25, 2006 stating the problem and requesting the return of all unused product.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Due to a manufacturing error after autoclaving the tubular retractor coating, physical vapor deposition (pvd) black titanium nitride (tin), may rub off.
Acción
The firm sent out a recall letter dated January 25, 2006 stating the problem and requesting the return of all unused product.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Due to a manufacturing error after autoclaving the tubular retractor coating, physical vapor deposition (pvd) black titanium nitride (tin), may rub off.
Acción
The firm sent out a recall letter dated January 25, 2006 stating the problem and requesting the return of all unused product.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Due to a manufacturing error after autoclaving the tubular retractor coating, physical vapor deposition (pvd) black titanium nitride (tin), may rub off.
Acción
The firm sent out a recall letter dated January 25, 2006 stating the problem and requesting the return of all unused product.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Due to a manufacturing error after autoclaving the tubular retractor coating, physical vapor deposition (pvd) black titanium nitride (tin), may rub off.
Acción
The firm sent out a recall letter dated January 25, 2006 stating the problem and requesting the return of all unused product.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Due to a manufacturing error after autoclaving the tubular retractor coating, physical vapor deposition (pvd) black titanium nitride (tin), may rub off.
Acción
The firm sent out a recall letter dated January 25, 2006 stating the problem and requesting the return of all unused product.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Due to a manufacturing error after autoclaving the tubular retractor coating, physical vapor deposition (pvd) black titanium nitride (tin), may rub off.
Acción
The firm sent out a recall letter dated January 25, 2006 stating the problem and requesting the return of all unused product.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Due to a manufacturing error after autoclaving the tubular retractor coating, physical vapor deposition (pvd) black titanium nitride (tin), may rub off.
Acción
The firm sent out a recall letter dated January 25, 2006 stating the problem and requesting the return of all unused product.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Due to a manufacturing error after autoclaving the tubular retractor coating, physical vapor deposition (pvd) black titanium nitride (tin), may rub off.
Acción
The firm sent out a recall letter dated January 25, 2006 stating the problem and requesting the return of all unused product.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Due to a manufacturing error after autoclaving the tubular retractor coating, physical vapor deposition (pvd) black titanium nitride (tin), may rub off.
Acción
The firm sent out a recall letter dated January 25, 2006 stating the problem and requesting the return of all unused product.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Due to a manufacturing error after autoclaving the tubular retractor coating, physical vapor deposition (pvd) black titanium nitride (tin), may rub off.
Acción
The firm sent out a recall letter dated January 25, 2006 stating the problem and requesting the return of all unused product.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Image orientation and orientation markers may not match when an image is rotated or flipped when the ct image is preset.
Acción
FujiFilm Medical Systems USA notified users by letter dated 2/3/06. Users are requested to deactivate the CT Image Processing functionality SWAT (Synapse Web Administration Tool).
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notas adicionales en la data
Stents, Drains And Dilators For The Biliary Ducts - Product Code FGE
Causa
The side of the boxes give incorrect sizes for these stents. the label front is correct.
Acción
Consignees were notified via telephone on 1/26/06 and a follow-up fax was sent.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notas adicionales en la data
Respirator, Surgical - Product Code MSH
Causa
Mislabeling-a customer reported mislabeled product display boxes. review of complaint samples and inventory confirmed that some product display boxes are labeled with incorrect model/size number.
Acción
The recalling process will be initiated by 2/22/06. Distributors will be notified of the recall through a certified recall letter and they will in turn notify and recall product from their customers and return all affected product to Inovel.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notas adicionales en la data
System, Test, Blood Glucose, Over The Counter - Product Code NBW
Causa
The device may give inaccurate elevated blood glucose test results. this may lead to over treatment and hypoglycemic complications may result.
Acción
On 2/17/06 the firm initiated the recall via its reps and on 2/22/06 notification was via letters explaining the reason for the recall and reporting that its reps will replace the units.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notas adicionales en la data
Single (Specified) Analyte Controls (Assayed And Unassayed) - Product Code JJX
Causa
The device may give inaccurate elevated blood glucose test results. this may lead to over treatment and hypoglycemic complications may result.
Acción
On 2/17/06 the firm initiated the recall via its reps and on 2/22/06 notification was via letters explaining the reason for the recall and reporting that its reps will replace the units.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notas adicionales en la data
Stent, Ureteral - Product Code FAD
Causa
Instructions for use (ifu) booklet missing pages 5-12. pages 5-8 in english; 9-12 in danish, describe stent duration, patient preparation, assembly, implanting, follow-up and removal instructions. ifu, device description, indications, contraindications, warnings, precautions, patient counseling, clinical usage, clinical study data, adverse events. one patient booklet lacked pages 3-6, & 55-58.
Acción
Consignees were notified via letter dated 3/1/06 that included one copy of the instructions. Consignees were asked to inform the firm of how many additional copies were needed for stocks on hand and instructed to make copies as needed until additional supplies are received.