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.
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.
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
ventilation accessories - Product Code BZD
Causa
Foreign material: glass fragments may present in the plastic bag material used to ship components.
Acción
The recalling firm issued a Recall Notification dated 10/18/07 to its customers. Replacement products were to be 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.
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.
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.
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
Stents, Drains And Dilators For The Biliary Ducts - Product Code FGE
Causa
A customer complaint received indicated that a prot¿g¿ stent, pn serb65-09-30-120 was found in a pouch that was not properly sealed. the prot¿g¿ gps stent system is 'double barrier' packaged and consists of a sealed inner tray in a sealed pouch. the pouch seal ensures sterility of the external surface of the inner tray. the inner tray seal containing the device was not affected.
Acción
A recall notification letter dated September 01, 2004 was sent to customers. Customers are to retain product until pick up by Ev3 sales representatives.
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
Test, Sickle Cell - Product Code GHM
Causa
Defective reaction vials from an in vitro diagnostic test kit may cause positive patient samples to be interpreted as false negatives.
Acción
The firm ceased distribution on 8/24/04 and initiated recall by certified letter dated 9/3/04, which was flagged as 'customer recall notification'. The notice advised of the defective vials and requested users to return response form with the numbers of kits to be returned for replacement.