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
Retractors - Product Code GAD
Causa
Ni-cr plated 1100 series retractors with a chromium finish were replaced by retractors with a hard-anodized finish after complaints of peeling were received.
Acción
For domestic customers, the firm sent product replacement letters to customers (as listed on the firm's invoices), and hospital operating room personnel on October 6, 2004. On November 8, 2004, a faxed letter was sent to the Purchasing/Materials Management Department of all customers. From November 9 through November 12, 2004, a phone call drive was conducted to contact appropriate individuals for each customer. For international customers, the firm notified distributors and obtained end user details from them. End users were then contacted and communicated with regarding the product replacement. In addition, the firm utilized its Summer and Fall 2004 newsletters to communicate the product replacement information.
Customers were encouraged to return NiCr coated products for a hard-anodized coated replacement 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
knee prosthesis - Product Code JWH
Causa
The polyethylene tibial articular surface may not lock into some of the tibial plates.
Acción
Consignees were notified by a letter dated 10/12/06 and sent to operating room supervisors and Zimmer distributors to cease using the product and to return it to the firm.
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.
Limited number of fastcath transseptal catheter introducers (ref #406850) are susceptible to the irrigation extension tube on the side port becoming disconnected when a pull force is applied.
Acción
The affected customers were notified on 10/5/06 by letter.
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
Retractors - Product Code GAD
Causa
Ni-cr plated 1100 series retractors with a chromium finish were replaced by retractors with a hard-anodized finish after complaints of peeling were received.
Acción
For domestic customers, the firm sent product replacement letters to customers (as listed on the firm's invoices), and hospital operating room personnel on October 6, 2004. On November 8, 2004, a faxed letter was sent to the Purchasing/Materials Management Department of all customers. From November 9 through November 12, 2004, a phone call drive was conducted to contact appropriate individuals for each customer. For international customers, the firm notified distributors and obtained end user details from them. End users were then contacted and communicated with regarding the product replacement. In addition, the firm utilized its Summer and Fall 2004 newsletters to communicate the product replacement information.
Customers were encouraged to return NiCr coated products for a hard-anodized coated replacement 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
Retractors - Product Code GAD
Causa
Ni-cr plated 1100 series retractors with a chromium finish were replaced by retractors with a hard-anodized finish after complaints of peeling were received.
Acción
For domestic customers, the firm sent product replacement letters to customers (as listed on the firm's invoices), and hospital operating room personnel on October 6, 2004. On November 8, 2004, a faxed letter was sent to the Purchasing/Materials Management Department of all customers. From November 9 through November 12, 2004, a phone call drive was conducted to contact appropriate individuals for each customer. For international customers, the firm notified distributors and obtained end user details from them. End users were then contacted and communicated with regarding the product replacement. In addition, the firm utilized its Summer and Fall 2004 newsletters to communicate the product replacement information.
Customers were encouraged to return NiCr coated products for a hard-anodized coated replacement 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
Computed Radiography System - Product Code MBQ
Causa
Users may experience one or more of four (4) problems; 1. image quality problem with full leg full spine exams. 2. unable to print 2 or more images on 1 film. 3. possible image loss when printing. 4. study date and time not showing up on imexius web.
Acción
A Service Bulletin to address the issues was created on 09/01/2006. Customers were notified of the plans to upgrade via telephone and email on 10/13/2006.
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
MRI - Product Code MOS
Causa
The firm determined that certain potential conditions for use of their medical device, outside of recommended practices, or operating manual descriptions, could result in a localized rf burn and/or electrical shock to a patient on which the device is being used.
Acción
The user/customers were notified of this recall with an ''Urgent Customer Safety Notification'' which was sent to the user/customers via Certified mail per recall letter dated 09/20/2006. The notification informs the customer(s) of this potential problem and the three (3) conditions under which this problem (patient becoming burned) could possibly occur. The notification goes on to inform the customers that the firm will be upgrading all 1.5T HD Head Neck & Spine Arrays so as to eliminate this potential hazard, at no cost to the customer and that a Service Representative will be contacting the customer in order to make arrangements to upgrade the coil on-site. A toll-free telelphone no. is provided in the notification letter for questions and/or comments. Lastly, the recall notification provides interim instructions which the customer should follow. The operator/technician should: ask that the patients place their hands at their sides during a scan; immediately discontinue the scan if the patient undergoing the scan starts to move; and stay in constant visual and oral contact with the patient undergoing the scan at all times.
For the 3.0T HD Head Neck Spine Array, Model 2415545, for GE 3.0T Excite MR System, The user/customers were notified of this recall with an ''Urgent Customer Safety Notification'' which was sent to the user/customers via Certified mail per recall letter dated 10/13/2006.
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
Healing abutment - Product Code DZE
Causa
Package integrity; sterility compromised-incomplete seals on the nylon bags in which the product is packed.
Acción
Each consignee will be contacted by email or telephone followed by a faxed letter. Each consignee was instructed to check their respective inventory for the recalled part and corresponding lot number. They were directed to return the product to the recalling firm.
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
bradycardia and tachycardia device programmer - Product Code KRG
Causa
St. jude medical has identified a low-frequency anomaly in the software used in the aps iii model 3500/3510 and merlin pcs model 3650 programmers that can lead to incorrect reporting of battery voltage, expected battery longevity and elective replacement indicator (eri) status.
Acción
The notification material was sent to physicians by FedEx. The advisory notification was sent by FedEx on Oct. 12, 2006, to arrive at the physicians' offices on Oct. 13th.
In the US, acknowledgement of receipt of the notification material will be monitored by St. Jude Medical CRMD in Sylmar, California. For the rest of the world it will be by various St. Jude offices and local distributors with this information being fed back to St. Jude Medical CRMD in Sylmar.
In addition, St. Jude Medical issued a press release on October 13, 2006. Plus information concerning this advisory can be found on St. Jude's website, www.sim.com
Completion of this advisory is estimated to be three months after its initiation.
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
bradycardia and tachycardia device programmer - Product Code KRG
Causa
St. jude medical has identified a low-frequency anomaly in the software used in the aps iii model 3500/3510 and merlin pcs model 3650 programmers that can lead to incorrect reporting of battery voltage, expected battery longevity and elective replacement indicator (eri) status.
Acción
The notification material was sent to physicians by FedEx. The advisory notification was sent by FedEx on Oct. 12, 2006, to arrive at the physicians' offices on Oct. 13th.
In the US, acknowledgement of receipt of the notification material will be monitored by St. Jude Medical CRMD in Sylmar, California. For the rest of the world it will be by various St. Jude offices and local distributors with this information being fed back to St. Jude Medical CRMD in Sylmar.
In addition, St. Jude Medical issued a press release on October 13, 2006. Plus information concerning this advisory can be found on St. Jude's website, www.sim.com
Completion of this advisory is estimated to be three months after its initiation.
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
Blood Glucose Test Strips - Product Code NBW
Causa
Counterfeit-(manufacturer unknown).
Acción
The recalling firm faxed, e-mailed and/or mailed ''Urgent Medical Device'' letters and response forms (dated 10/17/06) to the 5 distributor accounts.
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
pacemaker - Product Code DXY
Causa
St. jude medical has identified a low-frequency anomaly in the software used in the aps iii model 3500/3510 and merlin pcs model 3650 programmers that can lead to incorrect reporting of battery voltage, expected battery longevity and elective replacement indicator (eri) status.
Acción
The notification material was sent to physicians by FedEx. The advisory notification was sent by FedEx on Oct. 12, 2006, to arrive at the physicians' offices on Oct. 13th.
In the US, acknowledgement of receipt of the notification material will be monitored by St. Jude Medical CRMD in Sylmar, California. For the rest of the world it will be by various St. Jude offices and local distributors with this information being fed back to St. Jude Medical CRMD in Sylmar.
In addition, St. Jude Medical issued a press release on October 13, 2006. Plus information concerning this advisory can be found on St. Jude's website, www.sim.com
Completion of this advisory is estimated to be three months after its initiation.
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
spinal cord stimulation leads - Product Code LGW
Causa
A small number of unimplanted precision linear leads may have been assembled with incorrect electrode material. at high stimulation levels, the metal may corrode and dissolved metals may enter the patient.
Acción
In United States, the clinician recall notification letters were distributed by Fed-Ex or U.S. Postal Service certified mail on 09/21/2006. For the other regions, the in-country representatives started providing notification to the clinicians on 09/21/2006.
The recall notification letters will instruct physicians to immediately return the unimplanted 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
Tube Clamp adapters - Product Code ISH
Causa
Device fracturing: recent design and process changes leave the device susceptible to fracturing, which could cause the prosthesis to fail.
Acción
On October 6, 2006, SPS faxed a recall notification to the 187 customers who had purchased one or more BL120M Tube Clamp Adapters from SPS between August 29 and September 20, 2006. On October 9, SPS contacted those customers that had purchased five or more Adapters via telephone to confirm they had received the faxed recall notification. On October 10, SPS mailed another copy of the recall notification, via certified mail, return receipt requested to all of its customers that had purchased one or more BL120M Tube Clamp Adapters. The customers were told to send the BL120M Adapter back to SPS following replacement.
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
vital signs monitor - Product Code MWI
Causa
Potential to burn patient's finger. a nellcor pulse oximetry (sp02) sensor became hot when used with a propaq lt.
Acción
A letter dated October 22, 2006 was sent to customers between October 25-27,2006. The letter advised of the problem and requested the customer contact the firm to arrange for return of the monitor to be serviced. The customer will be provided with a temporary replacement. The dealers were requested to notify their 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
vital signs monitor - Product Code MWI
Causa
Potential to burn patient's finger. a nellcor pulse oximetry (sp02) sensor became hot when used with a propaq lt.
Acción
A letter dated October 22, 2006 was sent to customers between October 25-27,2006. The letter advised of the problem and requested the customer contact the firm to arrange for return of the monitor to be serviced. The customer will be provided with a temporary replacement. The dealers were requested to notify their 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
Catheter - Product Code KRA
Causa
Incorrect expiration date: the product's exterior box date may be labeled with a longer than actual expiration date (the pouch label is correct).
Acción
On 10/6/06, the firm initiated the recall and its notification was via letters explaining the reason for the recall and requesting the product be returned. Product will be destroyed upon return.
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
patient lift component - Product Code FSA
Causa
The kwiktrak gate stopper may fail and allow the ceiling lift to pass through to the end of the track and fall to the floor.
Acción
Arjo Inc. USA sent recall letters to the direct accounts on 10/30/06, informing them that if the ceiling lift is moved too fast or too forcefully into a closed gate, the gate stopper can be damaged, causing its function to fail. One consequence can be that the gate may remain open, allowing the ceiling lift to pass through to the end of the track. The letters requested the customer to visually inspect their Kwiktrak Gate installation used with their Maxisky-600 Ceiling Lift to determine if there are any signs of impact or burr marks on the closed gate stopper. Illustrations of a damaged and normal gate stopper were included. The customers were requested to stop use of the Kwiktrak track system if any signs of impact or burr marks are found, and contact the Arjo Quality Department at 1-800-323-1245, ext. 6140 for special instructions. If no signs of damage were found, the customers were reminded to make sure that they manually drive the ceiling lift in a gentler manner to prevent damage to the gate stopper, making sure that all personnel using the ceiling lifts are properly trained. The accounts were informed that Arjo personnel will contact them in the next few weeks to install an improved system that will eliminate the risks of failure.
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
epidural anesthesia tray - Product Code CAZ
Causa
Misbranded: tray label states 26g x 5/8 inch, needle is 25 g x 1 inch.
Acción
Smith Medical notified Dealers and direct customers contacted via letter delivered by Federal Express on October 27, 2006. Customers of dealers will be notified upon receipt of the dealer customer list.
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
Humidifier - Product Code BTT
Causa
Ac inlet connector failure that can result in thermal damage to the humidifier enclosure and/or ignition of materials external to the device.
Acción
The recalling firm issued a recall letter dated 10/25/06 to their domestic and Canadian dealers informing them of the problem and the need to contact the end users. These dealers were given two options: 1) contact the end user by forwarding a letter the recalling firm provided or 2) contacting the third party company with their distribution list. The recalling firm issued a recall letter dated 10/25/06 regarding the service repair kit and the need to contact end users that had the device repaired using this kit. The recalling firm issued a recall letter date 10/25/06 to the international customers informing them of the problem, contact the end users, and the need to destroy the recalled part.
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
Humidifier - Product Code BTT
Causa
Ac inlet connector failure that can result in thermal damage to the humidifier enclosure and/or ignition of materials external to the device.
Acción
The recalling firm issued a recall letter dated 10/25/06 to their domestic and Canadian dealers informing them of the problem and the need to contact the end users. These dealers were given two options: 1) contact the end user by forwarding a letter the recalling firm provided or 2) contacting the third party company with their distribution list. The recalling firm issued a recall letter dated 10/25/06 regarding the service repair kit and the need to contact end users that had the device repaired using this kit. The recalling firm issued a recall letter date 10/25/06 to the international customers informing them of the problem, contact the end users, and the need to destroy the recalled part.
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
Blood Glucose Test Strips - Product Code NBW
Causa
Counterfeit glucose test strips (manufacturer unknown).
Acción
Medical Plastic Devices, Quebec, Canada notiifed customers by telephone on 10/17/06 and completed notification by letter on 10/18/06.
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
Blood Glucose Test Strips - Product Code CGA
Causa
Counterfeit glucose test strips (manufacturer unknown).
Acción
Medical Plastic Devices, Quebec, Canada notiifed customers by telephone on 10/17/06 and completed notification by letter on 10/18/06.
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
Medical Imaging Communication Device - Product Code LMD
Causa
The power supply of a unit located in japan overheated and caused a smoke condition and a small amount of flame coming off the unit.
Acción
Letters were sent to all customers by first class US mail, certified receipt requested on 10/10/2006. Customers were also notified by fax and e-mail and a phone call on the same day.