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
Esophageal Dilator - Product Code KNQ
Causa
Mislabeling issues including; incorrect balloon diameters, lot number discrepancies, and incorrect type of dilator.
Acción
Notification Letters were sent to domestic consignees on 04/16/07 and to international consignees on 04/17/07. Consignees instructed to discontinue product use, sub recall to accounts sold product, and to contact Stericycle, Inc. at 1-800-668-4391 for instructions on returning 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.
Notas adicionales en la data
Esophageal Dilator - Product Code KNQ
Causa
Mislabeling issues including; incorrect balloon diameters, lot number discrepancies, and incorrect type of dilator.
Acción
Notification Letters were sent to domestic consignees on 04/16/07 and to international consignees on 04/17/07. Consignees instructed to discontinue product use, sub recall to accounts sold product, and to contact Stericycle, Inc. at 1-800-668-4391 for instructions on returning 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.
Notas adicionales en la data
Pyloric/Colonic Dilator - Product Code KNQ
Causa
Mislabeling issues including; incorrect balloon diameters, lot number discrepancies, and incorrect type of dilator.
Acción
Notification Letters were sent to domestic consignees on 04/16/07 and to international consignees on 04/17/07. Consignees instructed to discontinue product use, sub recall to accounts sold product, and to contact Stericycle, Inc. at 1-800-668-4391 for instructions on returning 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.
Notas adicionales en la data
Pyloric/Colonic Dilator - Product Code KNQ
Causa
Complaints received regarding pet balloon dilators for a variety of labeling errors, including: incorrect balloon diameters, lot number discrepancies, and incorrect type of dilator.
Acción
Notification Letters were sent to domestic consignees on 04/16/07 and to international consignees on 04/17/07. Consignees instructed to discontinue product use, sub recall to accounts sold product, and to contact Stericycle, Inc. at 1-800-668-4391 for instructions on returning 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.
Notas adicionales en la data
Pyloric/Colonic Dilator - Product Code KNQ
Causa
Mislabeling issues including; incorrect balloon diameters, lot number discrepancies, and incorrect type of dilator.
Acción
Notification Letters were sent to domestic consignees on 04/16/07 and to international consignees on 04/17/07. Consignees instructed to discontinue product use, sub recall to accounts sold product, and to contact Stericycle, Inc. at 1-800-668-4391 for instructions on returning 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.
Notas adicionales en la data
Pyloric/Colonic Dilator - Product Code KNQ
Causa
Mislabeling issues including; incorrect balloon diameters, lot number discrepancies, and incorrect type of dilator.
Acción
Notification Letters were sent to domestic consignees on 04/16/07 and to international consignees on 04/17/07. Consignees instructed to discontinue product use, sub recall to accounts sold product, and to contact Stericycle, Inc. at 1-800-668-4391 for instructions on returning 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.
Notas adicionales en la data
Pyloric/Colonic Dilator - Product Code KNQ
Causa
Mislabeling issues including; incorrect balloon diameters, lot number discrepancies, and incorrect type of dilator.
Acción
Notification Letters were sent to domestic consignees on 04/16/07 and to international consignees on 04/17/07. Consignees instructed to discontinue product use, sub recall to accounts sold product, and to contact Stericycle, Inc. at 1-800-668-4391 for instructions on returning 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.
Notas adicionales en la data
Pyloric/Colonic Dilator - Product Code KNQ
Causa
Mislabeling issues including; incorrect balloon diameters, lot number discrepancies, and incorrect type of dilator.
Acción
Notification Letters were sent to domestic consignees on 04/16/07 and to international consignees on 04/17/07. Consignees instructed to discontinue product use, sub recall to accounts sold product, and to contact Stericycle, Inc. at 1-800-668-4391 for instructions on returning 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.
Notas adicionales en la data
Pyloric/Colonic Dilator - Product Code KNQ
Causa
Mislabeling issues including; incorrect balloon diameters, lot number discrepancies, and incorrect type of dilator.
Acción
Notification Letters were sent to domestic consignees on 04/16/07 and to international consignees on 04/17/07. Consignees instructed to discontinue product use, sub recall to accounts sold product, and to contact Stericycle, Inc. at 1-800-668-4391 for instructions on returning 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.
Notas adicionales en la data
Bipolar Lead - Product Code LYJ
Causa
Dissolution/fractures to the leads of the vns therapy system.
Acción
Cyberonics issued a correction notice (Safety Alert) to physicians in June of 2007, informing them of the present labeling and including updated labeling to provide instructions on how to detect lead fractures and how to minimize risk to patients.
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
Bipolar Lead, - Product Code LYJ
Causa
Dissolution/fractures to the leads of the vns therapy system.
Acción
Cyberonics issued a correction notice (Safety Alert) to physicians in June of 2007, informing them of the present labeling and including updated labeling to provide instructions on how to detect lead fractures and how to minimize risk to patients.
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
Perrennia Lead - Product Code LYJ
Causa
Dissolution/fractures to the leads of the vns therapy system.
Acción
Cyberonics issued a correction notice (Safety Alert) to physicians in June of 2007, informing them of the present labeling and including updated labeling to provide instructions on how to detect lead fractures and how to minimize risk to patients.
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
analyzer, chemistry - Product Code JJE
Causa
One or more of four software issues : 1) calculation error for architect csystem assays using the spline math model. 2) the system configuration option, run controls onboard reagents by kit, does not function correctly for assays requiring a standard sample dilution. 3) infrequent data may be missing from automatically or manually printed reports generated on the architect system. 4) clinical chem.
Acción
Notification letters sent to consignees on 04/30/07. Consignees provided with work around instructions for the software glitches and asked to respond via fax using Customer Reply form acknowledging receipt, understanding and completion of correction letter. This is the short term fix pending software updates, validation,and full root cause determination.
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
analyzer, chemistry - Product Code JJE
Causa
One or more of four software issues : 1) calculation error for architect csystem assays using the spline math model. 2) the system configuration option, run controls onboard reagents by kit, does not function correctly for assays requiring a standard sample dilution. 3) infrequent data may be missing from automatically or manually printed reports generated on the architect system. 4) clinical chem.
Acción
Notification letters sent to consignees on 04/30/07. Consignees provided with work around instructions for the software glitches and asked to respond via fax using Customer Reply form acknowledging receipt, understanding and completion of correction letter. This is the short term fix pending software updates, validation,and full root cause determination.
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
analyzer, chemistry - Product Code JJE
Causa
One or more of four software issues : 1) calculation error for architect csystem assays using the spline math model. 2) the system configuration option, run controls onboard reagents by kit, does not function correctly for assays requiring a standard sample dilution. 3) infrequent data may be missing from automatically or manually printed reports generated on the architect system. 4) clinical chem.
Acción
Notification letters sent to consignees on 04/30/07. Consignees provided with work around instructions for the software glitches and asked to respond via fax using Customer Reply form acknowledging receipt, understanding and completion of correction letter. This is the short term fix pending software updates, validation,and full root cause determination.
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
analyzer, chemistry - Product Code JJE
Causa
One or more of four software issues : 1) calculation error for architect csystem assays using the spline math model. 2) the system configuration option, run controls onboard reagents by kit, does not function correctly for assays requiring a standard sample dilution. 3) infrequent data may be missing from automatically or manually printed reports generated on the architect system. 4) clinical chem.
Acción
Notification letters sent to consignees on 04/30/07. Consignees provided with work around instructions for the software glitches and asked to respond via fax using Customer Reply form acknowledging receipt, understanding and completion of correction letter. This is the short term fix pending software updates, validation,and full root cause determination.
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
B-hCG In Vitro Diagnostic - Product Code JHI
Causa
An increase in background counts elevates the results of low level samples up to approximately 6miu/ml. this is not enough to shift a negative result to positive on an undiluted sample. if low level samples are diluted then the background effect is magnified potentially yelding false positive results for pregnancy and or dilution inaccuracy.
Acción
The 4/10/2007 Product Recall Letter was sent to all customers who received the affected lots.
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
B-hCG In Vitro Diagnostic - Product Code JHI
Causa
An increase in background counts elevates the results of low level samples up to approximately 6miu/ml. this is not enough to shift a negative result to positive on an undiluted sample. if low level samples are diluted then the background effect is magnified potentially yelding false positive results for pregnancy and or dilution inaccuracy.
Acción
The 4/10/2007 Product Recall Letter was sent to all customers who received the affected lots.
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
Insulin Infusion Pumps - Product Code LZG
Causa
Exposure to magnetic resonance imaging (mri) has resulted in damage to the component that monitors and controls movement of the motor in the minimed paradigm insulin infusion pump. although there were alarms as a result of the damage, some users cleared these alarms and continued using the pump. under such conditions, the pump will significantly over-deliver; potentially causing severe hypoglycemi.
Acción
Firm mailed Medical Device Safety letters on April 24, 2007, to healthcare professionals, existing pump users and MRI facilities reiterating the existing warning in the pump User Guide to avoid exposing the pump to MRI (or similar high strength electromagnetic fields) and strengthening previous warning by specifically mentioning the potential for over-delivery and severe hypoglycemia. Firm is also including an insert with this information with any Paradigm infusion pumps shipped to new customers.
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
magnetic resonance imaging system - Product Code LNH
Causa
Potential for gaseous helium to improperly vent, resulting in rupture of the magnet vessel and venting of helium into the mri site.
Acción
On 4/30/07 Philips sent an Urgent Device Correction letter dated April 25, 2007 via certified mail to customers. The letter advises customers of the issue and that that a representative will visit the sites, inspect and correct the problem if indicated.
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
magnetic resonance imaging system - Product Code LNH
Causa
Potential for gaseous helium to improperly vent, resulting in rupture of the magnet vessel and venting of helium into the mri site.
Acción
On 4/30/07 Philips sent an Urgent Device Correction letter dated April 25, 2007 via certified mail to customers. The letter advises customers of the issue and that that a representative will visit the sites, inspect and correct the problem if indicated.
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
knee prosthesis instrument - Product Code HRY
Causa
Angled insert impactor may scratch tibial insert on the articulating surface, causing increased wear at the damaged site.
Acción
Firm notified consignees regarding recall via letter on 08/09/07. Consignees informed that Encore customer service representatives would be contacting them to exchange recalled units with replacements.
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
magnetic resonance imaging system - Product Code LNH
Causa
Potential for gaseous helium to improperly vent, resulting in rupture of the magnet vessel and venting of helium into the mri site.
Acción
On 4/30/07 Philips sent an Urgent Device Correction letter dated April 25, 2007 via certified mail to customers. The letter advises customers of the issue and that that a representative will visit the sites, inspect and correct the problem if indicated.
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
magnetic resonance imaging system - Product Code LNH
Causa
Potential for gaseous helium to improperly vent, resulting in rupture of the magnet vessel and venting of helium into the mri site.
Acción
On 4/30/07 Philips sent an Urgent Device Correction letter dated April 25, 2007 via certified mail to customers. The letter advises customers of the issue and that that a representative will visit the sites, inspect and correct the problem if indicated.
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
Theophylline Reagent - Product Code LER
Causa
A decrease in mp values (calibration curve net polarization value) has been observed with this reagent lot at all calibrator levels and may produce the following results: calibration error code 148 (polarization too small), calibration error code 172 (calibration not stored or calibration not accepted) controls out of range (when using a stored calibration curve).
Acción
An April 11, 2007, Product Recall Letter was sent to all customers who received the affected lot. All customers who received the affected lot will be contacted. The following communication types were used: Product Recall Letter & Customer Reply Form. Letters were sent to customers by Federal Express Priority mail.
The Customers were instructed the following: To discontinue use of and destroy IMx Theophylline reagent lot 41610QI00.
If they had forwarded the lots listed in the Product Recall letter to other laboratories, they were instructed to inform them of this Product Recall and provide a copy of this letter to them. They also we instructed to retain a copy of the communication for their records