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.
The product insert for the test kits is incorrect with regard to the acceptable storage temperature for the agarose ief gel component. the kit and ief gel labels indicate the correct storage temperature of 2-8 degrees c. the product insert incorrectly indicates that the product may be stored at 2-30 degrees c.
Acción
The firm contacted their consignees by letter dated 9/14/04.
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
Manometer, Spinal-Fluid - Product Code FMJ
Causa
Sterility of the device is compromised due to packaging defects.
Acción
Smiths Medical, ASD notified consignees by letter dated September 9, 2004 by FedEx. Customers and dealers are directed to fax back the attached Reply Letter to the Smiths Medical Regulatory Affairs Department at 603-358-1017, even if the customer/dealer no longer has affected products in inventory, Questions are directed to Customer Service at 1-800-258-5361, prompt 1.
On 9/17/04, Smiths notified 48 consignees by Fed''X letter of 3 -additional lot codes for Product Code: 4252.
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
Manometer, Spinal-Fluid - Product Code FMJ
Causa
Sterility of the device is compromised due to packaging defects.
Acción
Smiths Medical, ASD notified consignees by letter dated September 9, 2004 by FedEx. Customers and dealers are directed to fax back the attached Reply Letter to the Smiths Medical Regulatory Affairs Department at 603-358-1017, even if the customer/dealer no longer has affected products in inventory, Questions are directed to Customer Service at 1-800-258-5361, prompt 1.
On 9/17/04, Smiths notified 48 consignees by Fed''X letter of 3 -additional lot codes for Product Code: 4252.
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
Manometer, Spinal-Fluid - Product Code FMJ
Causa
Sterility of the device is compromised due to packaging defects.
Acción
Smiths Medical, ASD notified consignees by letter dated September 9, 2004 by FedEx. Customers and dealers are directed to fax back the attached Reply Letter to the Smiths Medical Regulatory Affairs Department at 603-358-1017, even if the customer/dealer no longer has affected products in inventory, Questions are directed to Customer Service at 1-800-258-5361, prompt 1.
On 9/17/04, Smiths notified 48 consignees by Fed''X letter of 3 -additional lot codes for Product Code: 4252.
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
Manometer, Spinal-Fluid - Product Code FMJ
Causa
Sterility of the device is compromised due to packaging defects.
Acción
Smiths Medical, ASD notified consignees by letter dated September 9, 2004 by FedEx. Customers and dealers are directed to fax back the attached Reply Letter to the Smiths Medical Regulatory Affairs Department at 603-358-1017, even if the customer/dealer no longer has affected products in inventory, Questions are directed to Customer Service at 1-800-258-5361, prompt 1.
On 9/17/04, Smiths notified 48 consignees by Fed''X letter of 3 -additional lot codes for Product Code: 4252.
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.
Sterility of the device is compromised due to packaging defects.
Acción
Smiths Medical, ASD notified consignees by letter dated September 9, 2004 by FedEx. Customers and dealers are directed to fax back the attached Reply Letter to the Smiths Medical Regulatory Affairs Department at 603-358-1017, even if the customer/dealer no longer has affected products in inventory, Questions are directed to Customer Service at 1-800-258-5361, prompt 1.
On 9/17/04, Smiths notified 48 consignees by Fed''X letter of 3 -additional lot codes for Product Code: 4252.
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.
Sterility of the device is compromised due to packaging defects.
Acción
Smiths Medical, ASD notified consignees by letter dated September 9, 2004 by FedEx. Customers and dealers are directed to fax back the attached Reply Letter to the Smiths Medical Regulatory Affairs Department at 603-358-1017, even if the customer/dealer no longer has affected products in inventory, Questions are directed to Customer Service at 1-800-258-5361, prompt 1.
On 9/17/04, Smiths notified 48 consignees by Fed''X letter of 3 -additional lot codes for Product Code: 4252.
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
Hip Stems - Product Code LWJ
Causa
Sterility (package integrity) compromised: device package damaged during shipment.
Acción
The recalling firm issued an Important Recall Notice letter dated 10/10/07 to all their customers informing them of the problem and the need to return the 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.
Sterility of the device is compromised due to packaging defects.
Acción
Smiths Medical, ASD notified consignees by letter dated September 9, 2004 by FedEx. Customers and dealers are directed to fax back the attached Reply Letter to the Smiths Medical Regulatory Affairs Department at 603-358-1017, even if the customer/dealer no longer has affected products in inventory, Questions are directed to Customer Service at 1-800-258-5361, prompt 1.
On 9/17/04, Smiths notified 48 consignees by Fed''X letter of 3 -additional lot codes for Product Code: 4252.
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
Causa
Sterility of the device is compromised due to packaging defects.
Acción
Smiths Medical, ASD notified consignees by letter dated September 9, 2004 by FedEx. Customers and dealers are directed to fax back the attached Reply Letter to the Smiths Medical Regulatory Affairs Department at 603-358-1017, even if the customer/dealer no longer has affected products in inventory, Questions are directed to Customer Service at 1-800-258-5361, prompt 1.
On 9/17/04, Smiths notified 48 consignees by Fed''X letter of 3 -additional lot codes for Product Code: 4252.
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
Causa
Sterility of the device is compromised due to packaging defects.
Acción
Smiths Medical, ASD notified consignees by letter dated September 9, 2004 by FedEx. Customers and dealers are directed to fax back the attached Reply Letter to the Smiths Medical Regulatory Affairs Department at 603-358-1017, even if the customer/dealer no longer has affected products in inventory, Questions are directed to Customer Service at 1-800-258-5361, prompt 1.
On 9/17/04, Smiths notified 48 consignees by Fed''X letter of 3 -additional lot codes for Product Code: 4252.
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
Causa
Sterility of the device is compromised due to packaging defects.
Acción
Smiths Medical, ASD notified consignees by letter dated September 9, 2004 by FedEx. Customers and dealers are directed to fax back the attached Reply Letter to the Smiths Medical Regulatory Affairs Department at 603-358-1017, even if the customer/dealer no longer has affected products in inventory, Questions are directed to Customer Service at 1-800-258-5361, prompt 1.
On 9/17/04, Smiths notified 48 consignees by Fed''X letter of 3 -additional lot codes for Product Code: 4252.
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
Causa
Sterility of the device is compromised due to packaging defects.
Acción
Smiths Medical, ASD notified consignees by letter dated September 9, 2004 by FedEx. Customers and dealers are directed to fax back the attached Reply Letter to the Smiths Medical Regulatory Affairs Department at 603-358-1017, even if the customer/dealer no longer has affected products in inventory, Questions are directed to Customer Service at 1-800-258-5361, prompt 1.
On 9/17/04, Smiths notified 48 consignees by Fed''X letter of 3 -additional lot codes for Product Code: 4252.
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
Stopcock, I.V. Set - Product Code FMG
Causa
Sterility of the device is compromised due to packaging defects.
Acción
Smiths Medical, ASD notified consignees by letter dated September 9, 2004 by FedEx. Customers and dealers are directed to fax back the attached Reply Letter to the Smiths Medical Regulatory Affairs Department at 603-358-1017, even if the customer/dealer no longer has affected products in inventory, Questions are directed to Customer Service at 1-800-258-5361, prompt 1.
On 9/17/04, Smiths notified 48 consignees by Fed''X letter of 3 -additional lot codes for Product Code: 4252.
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
Detector And Alarm, Arrhythmia - Product Code DSI
Causa
The following two conditions may occur with the printing of full disclosure strips and reports, printing of the alarm history events stored on a ge unity network patient data server (pds), and printing of caliper reports in the ge cic pro central station monitoring product, 1) a delay or cessation in updating portions of th display screen: or, 2) system reset/restart.
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
Stopcock, I.V. Set - Product Code FMG
Causa
Sterility of the device is compromised due to packaging defects.
Acción
Smiths Medical, ASD notified consignees by letter dated September 9, 2004 by FedEx. Customers and dealers are directed to fax back the attached Reply Letter to the Smiths Medical Regulatory Affairs Department at 603-358-1017, even if the customer/dealer no longer has affected products in inventory, Questions are directed to Customer Service at 1-800-258-5361, prompt 1.
On 9/17/04, Smiths notified 48 consignees by Fed''X letter of 3 -additional lot codes for Product Code: 4252.
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
Stopcock, I.V. Set - Product Code FMG
Causa
Sterility of the device is compromised due to packaging defects.
Acción
Smiths Medical, ASD notified consignees by letter dated September 9, 2004 by FedEx. Customers and dealers are directed to fax back the attached Reply Letter to the Smiths Medical Regulatory Affairs Department at 603-358-1017, even if the customer/dealer no longer has affected products in inventory, Questions are directed to Customer Service at 1-800-258-5361, prompt 1.
On 9/17/04, Smiths notified 48 consignees by Fed''X letter of 3 -additional lot codes for Product Code: 4252.
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
Stopcock, I.V. Set - Product Code FMG
Causa
Sterility of the device is compromised due to packaging defects.
Acción
Smiths Medical, ASD notified consignees by letter dated September 9, 2004 by FedEx. Customers and dealers are directed to fax back the attached Reply Letter to the Smiths Medical Regulatory Affairs Department at 603-358-1017, even if the customer/dealer no longer has affected products in inventory, Questions are directed to Customer Service at 1-800-258-5361, prompt 1.
On 9/17/04, Smiths notified 48 consignees by Fed''X letter of 3 -additional lot codes for Product Code: 4252.
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
Stopcock, I.V. Set - Product Code FMG
Causa
Sterility of the device is compromised due to packaging defects.
Acción
Smiths Medical, ASD notified consignees by letter dated September 9, 2004 by FedEx. Customers and dealers are directed to fax back the attached Reply Letter to the Smiths Medical Regulatory Affairs Department at 603-358-1017, even if the customer/dealer no longer has affected products in inventory, Questions are directed to Customer Service at 1-800-258-5361, prompt 1.
On 9/17/04, Smiths notified 48 consignees by Fed''X letter of 3 -additional lot codes for Product Code: 4252.
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
Stopcock, I.V. Set - Product Code FMG
Causa
Sterility of the device is compromised due to packaging defects.
Acción
Smiths Medical, ASD notified consignees by letter dated September 9, 2004 by FedEx. Customers and dealers are directed to fax back the attached Reply Letter to the Smiths Medical Regulatory Affairs Department at 603-358-1017, even if the customer/dealer no longer has affected products in inventory, Questions are directed to Customer Service at 1-800-258-5361, prompt 1.
On 9/17/04, Smiths notified 48 consignees by Fed''X letter of 3 -additional lot codes for Product Code: 4252.
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
Stopcock, I.V. Set - Product Code FMG
Causa
Sterility of the device is compromised due to packaging defects.
Acción
Smiths Medical, ASD notified consignees by letter dated September 9, 2004 by FedEx. Customers and dealers are directed to fax back the attached Reply Letter to the Smiths Medical Regulatory Affairs Department at 603-358-1017, even if the customer/dealer no longer has affected products in inventory, Questions are directed to Customer Service at 1-800-258-5361, prompt 1.
On 9/17/04, Smiths notified 48 consignees by Fed''X letter of 3 -additional lot codes for Product Code: 4252.
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.
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
Stopcock, I.V. Set - Product Code FMG
Causa
Sterility of the device is compromised due to packaging defects.
Acción
Smiths Medical, ASD notified consignees by letter dated September 9, 2004 by FedEx. Customers and dealers are directed to fax back the attached Reply Letter to the Smiths Medical Regulatory Affairs Department at 603-358-1017, even if the customer/dealer no longer has affected products in inventory, Questions are directed to Customer Service at 1-800-258-5361, prompt 1.
On 9/17/04, Smiths notified 48 consignees by Fed''X letter of 3 -additional lot codes for Product Code: 4252.
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
Stopcock, I.V. Set - Product Code FMG
Causa
Sterility of the device is compromised due to packaging defects.
Acción
Smiths Medical, ASD notified consignees by letter dated September 9, 2004 by FedEx. Customers and dealers are directed to fax back the attached Reply Letter to the Smiths Medical Regulatory Affairs Department at 603-358-1017, even if the customer/dealer no longer has affected products in inventory, Questions are directed to Customer Service at 1-800-258-5361, prompt 1.
On 9/17/04, Smiths notified 48 consignees by Fed''X letter of 3 -additional lot codes for Product Code: 4252.
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
Stopcock, I.V. Set - Product Code FMG
Causa
Sterility of the device is compromised due to packaging defects.
Acción
Smiths Medical, ASD notified consignees by letter dated September 9, 2004 by FedEx. Customers and dealers are directed to fax back the attached Reply Letter to the Smiths Medical Regulatory Affairs Department at 603-358-1017, even if the customer/dealer no longer has affected products in inventory, Questions are directed to Customer Service at 1-800-258-5361, prompt 1.
On 9/17/04, Smiths notified 48 consignees by Fed''X letter of 3 -additional lot codes for Product Code: 4252.