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
Calibrator, secondary - Product Code JIT
Causa
Ipth assay- reagent and calibrator lots may have demonstrated higher than anticipated variability.
Acción
Siemens sent an Urgent Medical Device Correction letter dated May 2013 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. For questions, contact your Siemens Technical Solutions Center or your local Siemens technical support.
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.
Intuitive surgical is implementing a voluntary field action to implement a modified inspection process for the 5 mm cannula (pn 420011) and 5 mm flared cannula (pn 420262).
Acción
Intuitive Surgical sent an "URGENT MEDICAL DEVICE CORRECTION" letter dated May 14, 2013 to all affected customers. The letter identified the product,
problem, and actions to be taken by the customers. Contact Customer Service at 800-876-1310 for questions regarding this notice.
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
Shunt, central nervous system and components - Product Code JXG
Causa
Codman certas programmable valves used for hydrocephalus may not operate properly.
Acción
Codman issued an Urgent Notice dated May 16, 2013, to all affected customers. The letter identifed the affected product, problem and actions to be taken. Mitigation instructions are provided and if not followed or are not successful, either issue could lead to symptoms associated with under- or over-drainage. Units not implanted are to be returned. A U.S Acknowledgement Form and fax are requested to be completed and faxed to: 1-888-943-4193, or e-mail the form to codman8894@stericycle.com. If you have any questions on concerns in regards to this recall, please contact your Codman Representative or Stericycle at 1-888-943-2395.
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
Shunt, central nervous system and components - Product Code JXG
Causa
Codman certas programmable valves used for hydrocephalus may not operate properly.
Acción
Codman issued an Urgent Notice dated May 16, 2013, to all affected customers. The letter identifed the affected product, problem and actions to be taken. Mitigation instructions are provided and if not followed or are not successful, either issue could lead to symptoms associated with under- or over-drainage. Units not implanted are to be returned. A U.S Acknowledgement Form and fax are requested to be completed and faxed to: 1-888-943-4193, or e-mail the form to codman8894@stericycle.com. If you have any questions on concerns in regards to this recall, please contact your Codman Representative or Stericycle at 1-888-943-2395.
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
Shunt, central nervous system and components - Product Code JXG
Causa
Codman certas programmable valves used for hydrocephalus may not operate properly.
Acción
Codman issued an Urgent Notice dated May 16, 2013, to all affected customers. The letter identifed the affected product, problem and actions to be taken. Mitigation instructions are provided and if not followed or are not successful, either issue could lead to symptoms associated with under- or over-drainage. Units not implanted are to be returned. A U.S Acknowledgement Form and fax are requested to be completed and faxed to: 1-888-943-4193, or e-mail the form to codman8894@stericycle.com. If you have any questions on concerns in regards to this recall, please contact your Codman Representative or Stericycle at 1-888-943-2395.
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
Shunt, central nervous system and components - Product Code JXG
Causa
Codman certas programmable valves used for hydrocephalus may not operate properly.
Acción
Codman issued an Urgent Notice dated May 16, 2013, to all affected customers. The letter identifed the affected product, problem and actions to be taken. Mitigation instructions are provided and if not followed or are not successful, either issue could lead to symptoms associated with under- or over-drainage. Units not implanted are to be returned. A U.S Acknowledgement Form and fax are requested to be completed and faxed to: 1-888-943-4193, or e-mail the form to codman8894@stericycle.com. If you have any questions on concerns in regards to this recall, please contact your Codman Representative or Stericycle at 1-888-943-2395.
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 has the potential for false negative or delayed reaction for arginine (arg) results. in addition, 42 hour identification panel holds may occur due to a weak arg reaction.
Acción
Siemens sent an Urgent Field Safety Notice dated May 2013 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. Contact your local Siemens Healthcare Diagnostics Representative for information concerning this notice.
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
Shunt, central nervous system and components - Product Code JXG
Causa
Codman certas programmable valves used for hydrocephalus may not operate properly.
Acción
Codman issued an Urgent Notice dated May 16, 2013, to all affected customers. The letter identifed the affected product, problem and actions to be taken. Mitigation instructions are provided and if not followed or are not successful, either issue could lead to symptoms associated with under- or over-drainage. Units not implanted are to be returned. A U.S Acknowledgement Form and fax are requested to be completed and faxed to: 1-888-943-4193, or e-mail the form to codman8894@stericycle.com. If you have any questions on concerns in regards to this recall, please contact your Codman Representative or Stericycle at 1-888-943-2395.
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
Shunt, central nervous system and components - Product Code JXG
Causa
Codman certas programmable valves used for hydrocephalus may not operate properly.
Acción
Codman issued an Urgent Notice dated May 16, 2013, to all affected customers. The letter identifed the affected product, problem and actions to be taken. Mitigation instructions are provided and if not followed or are not successful, either issue could lead to symptoms associated with under- or over-drainage. Units not implanted are to be returned. A U.S Acknowledgement Form and fax are requested to be completed and faxed to: 1-888-943-4193, or e-mail the form to codman8894@stericycle.com. If you have any questions on concerns in regards to this recall, please contact your Codman Representative or Stericycle at 1-888-943-2395.
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
Shunt, central nervous system and components - Product Code JXG
Causa
Codman certas programmable valves used for hydrocephalus may not operate properly.
Acción
Codman issued an Urgent Notice dated May 16, 2013, to all affected customers. The letter identifed the affected product, problem and actions to be taken. Mitigation instructions are provided and if not followed or are not successful, either issue could lead to symptoms associated with under- or over-drainage. Units not implanted are to be returned. A U.S Acknowledgement Form and fax are requested to be completed and faxed to: 1-888-943-4193, or e-mail the form to codman8894@stericycle.com. If you have any questions on concerns in regards to this recall, please contact your Codman Representative or Stericycle at 1-888-943-2395.
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, irrigation, urological - Product Code LJH
Causa
A firm's internal investigation led to the discovery of pinholes in the packaging of the products. the pinholes are not likely to be detected by the end user prior to use and could compromise the sterile barrier properties of the packaging.
Acción
Baxter sent an Urgent Product Recall letter dated May 15, 2013 to all affected custorners. The letter identified the affected product, problem and actions to be taken. Customers were requested to remove all affected products and return for credit by contacting Baxter Healthcare Center for Service at 888-229-0001. Customers were instructed to complete the attached Customer Reply Form and return it to Baxter by either faxing to 224-270-5457 or scanning and e-mailing the reply form to fca@baxter.com
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
It has been confirmed from in-house testing that direct bilirubin (dbil), and total bilirubin (tbil) claimed in thermo scientific mas bilirubin systems are displaying reduced stability.
Acción
ThermoFisher Scientific sent a Product Recall Notification letter dated May 13, 2013, by Certified US mail to all affected customer. The letter identified the product the problem and the action needed to be taken by the customers.
Customers were instructed
1. Determine if you are using or have inventory of the recalled product.
2. Discontinue use of the product immediately.
3. Evaluate quality controls. They may vary among laboratories and should be evaluated according to laboratory procedures.
4. Retain a copy of the letter for laboratory records.
5. If any of the affected lots of MAS Bilirubin had been forwarded to another laboratory, please provide a copy of the recall letter to them.
6. Complete and return the response form within 5 days.
Letters also provide an alternative product - MAS Bilirubin part number BC103.
Questions or concerns may be directed to Technical Services at 1-800-232-3342 or 510-979-5417.
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 recall of the loaner bin and sterilization trays for implants and instruments was initiated by orthopedic alliance because the directions for use and surgical techniques were not being provided to every physician
and for every surgery.
Acción
A recall letter dated 3/8/13 was sent to all customers who purchased loaner bins and sterilization trays for implants and instruments from Orthopedic Alliance. The letter informed the customers of the problem identified
and the actions to be taken. Customers are instructed to call the office at the number (951) 304-9001 if they are requesting paper copies of any of the literature.
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 recall of the loaner bin and sterilization trays for implants and instruments was initiated by orthopedic alliance because the directions for use and surgical techniques were not being provided to every physician
and for every surgery.
Acción
A recall letter dated 3/8/13 was sent to all customers who purchased loaner bins and sterilization trays for implants and instruments from Orthopedic Alliance. The letter informed the customers of the problem identified
and the actions to be taken. Customers are instructed to call the office at the number (951) 304-9001 if they are requesting paper copies of any of the literature.
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 recall of the loaner bin and sterilization trays for implants and instruments was initiated by orthopedic alliance because the directions for use and surgical techniques were not being provided to every physician
and for every surgery.
Acción
A recall letter dated 3/8/13 was sent to all customers who purchased loaner bins and sterilization trays for implants and instruments from Orthopedic Alliance. The letter informed the customers of the problem identified
and the actions to be taken. Customers are instructed to call the office at the number (951) 304-9001 if they are requesting paper copies of any of the literature.
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 recall of the loaner bin and sterilization trays for implants and instruments was initiated by orthopedic alliance because the directions for use and surgical techniques were not being provided to every physician
and for every surgery.
Acción
A recall letter dated 3/8/13 was sent to all customers who purchased loaner bins and sterilization trays for implants and instruments from Orthopedic Alliance. The letter informed the customers of the problem identified
and the actions to be taken. Customers are instructed to call the office at the number (951) 304-9001 if they are requesting paper copies of any of the literature.
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 recall of the loaner bin and sterilization trays for implants and instruments was initiated by orthopedic alliance because the directions for use and surgical techniques were not being provided to every physician
and for every surgery.
Acción
A recall letter dated 3/8/13 was sent to all customers who purchased loaner bins and sterilization trays for implants and instruments from Orthopedic Alliance. The letter informed the customers of the problem identified
and the actions to be taken. Customers are instructed to call the office at the number (951) 304-9001 if they are requesting paper copies of any of the literature.
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
Screw, fixation, bone - Product Code HWC
Causa
The recall of the loaner bin and sterilization trays for implants and instruments was initiated by orthopedic alliance because the directions for use and surgical techniques were not being provided to every physician
and for every surgery.
Acción
A recall letter dated 3/8/13 was sent to all customers who purchased loaner bins and sterilization trays for implants and instruments from Orthopedic Alliance. The letter informed the customers of the problem identified
and the actions to be taken. Customers are instructed to call the office at the number (951) 304-9001 if they are requesting paper copies of any of the literature.
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 recall of the loaner bin and sterilization trays for implants and instruments was initiated by orthopedic alliance because the directions for use and surgical techniques were not being provided to every physician
and for every surgery.
Acción
A recall letter dated 3/8/13 was sent to all customers who purchased loaner bins and sterilization trays for implants and instruments from Orthopedic Alliance. The letter informed the customers of the problem identified
and the actions to be taken. Customers are instructed to call the office at the number (951) 304-9001 if they are requesting paper copies of any of the literature.
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 recall of the loaner bin and sterilization trays for implants and instruments was initiated by orthopedic alliance because the directions for use and surgical techniques were not being provided to every physician
and for every surgery.
Acción
A recall letter dated 3/8/13 was sent to all customers who purchased loaner bins and sterilization trays for implants and instruments from Orthopedic Alliance. The letter informed the customers of the problem identified
and the actions to be taken. Customers are instructed to call the office at the number (951) 304-9001 if they are requesting paper copies of any of the literature.
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 recall of the loaner bin and sterilization trays for implants and instruments was initiated by spinal solutions because the directions for use and surgical techniques were not being provided to every physician and for every surgery.
Acción
Spinal Solutions sent a recall letter dated March 8, 2013 to all customers who purchased loaner bins and sterilization trays for implants and instruments from Spinal Solutions. The letter identified the affected product, problem identified and actions to be taken. Customers are instructed to call the office at the number (951) 304-9001 if they are requesting paper copies of any of the literature.
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 recall of the loaner bin and sterilization trays for implants and instruments was initiated by spinal solutions because the directions for use and surgical techniques were not being provided to every physician and for every surgery.
Acción
Spinal Solutions sent a recall letter dated March 8, 2013 to all customers who purchased loaner bins and sterilization trays for implants and instruments from Spinal Solutions. The letter identified the affected product, problem identified and actions to be taken. Customers are instructed to call the office at the number (951) 304-9001 if they are requesting paper copies of any of the literature.
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 recall of the loaner bin and sterilization trays for implants and instruments was initiated by spinal solutions because the directions for use and surgical techniques were not being provided to every physician and for every surgery.
Acción
Spinal Solutions sent a recall letter dated March 8, 2013 to all customers who purchased loaner bins and sterilization trays for implants and instruments from Spinal Solutions. The letter identified the affected product, problem identified and actions to be taken. Customers are instructed to call the office at the number (951) 304-9001 if they are requesting paper copies of any of the literature.
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 recall of the loaner bin and sterilization trays for implants and instruments was initiated by spinal solutions because the directions for use and surgical techniques were not being provided to every physician and for every surgery.
Acción
Spinal Solutions sent a recall letter dated March 8, 2013 to all customers who purchased loaner bins and sterilization trays for implants and instruments from Spinal Solutions. The letter identified the affected product, problem identified and actions to be taken. Customers are instructed to call the office at the number (951) 304-9001 if they are requesting paper copies of any of the literature.
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 recall of the loaner bin and sterilization trays for implants and instruments was initiated by spinal solutions because the directions for use and surgical techniques were not being provided to every physician and for every surgery.
Acción
Spinal Solutions sent a recall letter dated March 8, 2013 to all customers who purchased loaner bins and sterilization trays for implants and instruments from Spinal Solutions. The letter identified the affected product, problem identified and actions to be taken. Customers are instructed to call the office at the number (951) 304-9001 if they are requesting paper copies of any of the literature.