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
Michclone associate's has received two complaints concerning the powder vial included in the 100 test kit observed producing pressure while sealed. when the powders are opened, the pressure from within the vial releases a small amount of powder into the air.
this powder. if released near the face and inhaled can cause minor irritation resulting in sneezing and nasal
congestion. investigation f.
Acción
Michclone Associates, Inc. sent an "URGENT MEDICAL DEVICE RECALL" letter dated March 15, 2012 to all affected customers. The letter identifies the product, problem, and actions to be taken by the customers. The letter instructs customers to identify affected lots, notify sub accounts, and complete and return the response form to arrange return of unused product and replacement . Forms can be returned by FAX 248(307)-9498, mail: Michclone Associates Inc. 680 Ajax Drive, Madison Heights, MI 48118 or Email: toben@greatlakesdiag.com. Questions and concerns should be addressed to Technical Support Department at 248-307-9494.
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
Two complaints received concerning the powder vial included in the 100 test kit observed producing pressure while sealed. when the powders are opened, the pressure from within the vial releases a small amount of powder into the air.
this powder. if released near the face and inhaled can cause minor irritation resulting in sneezing and nasal
congestion. investigation found no affect on the perf.
Acción
Michclone Associates, Inc. sent an "URGENT MEDICAL DEVICE RECALL" letter dated March 15, 2012 to all affected customers. The letter identifies the product, problem, and actions to be taken by the customers. The letter instructs customers to identify affected lots, notify sub accounts, and complete and return the response form to arrange return of unused product and replacement . Forms can be returned by FAX 248(307)-9498, mail: Michclone Associates Inc. 680 Ajax Drive, Madison Heights, MI 48118 or Email: toben@greatlakesdiag.com. Questions and concerns should be addressed to Technical Support Department at 248-307-9494.
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.
Boston scientific latitude¿ patient management system communicators were shipped to the incorrect patients.
Acción
The patients were notified via phone starting on 2/24/12 that their communicator will not be able to activate successfully and that their communicator and sensors will be replaced. If the patient could not be reached via phone or voice mail, a Boston Scientific letter dated 2/29/12 was sent to the patient. The letter described the problem, explained What is a LATITUDE Communicator and What should you do. Questions were directed to Patient Services at (866) 484-3268.
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.
Isolated lots of the 12fr sls ii laser sheath can have a split in the outer jacket.
Acción
Spectranetics sent Recall Notices to all customers on March 14, 2012. The product issue was described and requested actions were included. Questions were directed to Customer Service at 1-800-231-0978 (US).
Cuban data is current through 2018. All of the data comes from the Health Ministry of Cuba, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Cuba.
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.
Medtronic has confirmed that an algorithm used in the model 8870 application card software has resulted
in nine (9) occurrences of an incorrectly displayed schedule to replace the pump by date. it is estimated that there are more than 140,000 synchromed ii pump implants worldwide. a patient with a pump reaching eos prior to replacement may experience the return of underlying symptoms and/or
wit.
Acción
Medtronic mailed an "Urgent Medical Device Correction " letter addressed to Dear Healthcare Professional on March 12, 2012. The letter described the problem, Background, Clinical Manifestations, Recommendations, and Additional Information.
To ensure there is no interruption in therapy, pump replacements should be scheduled before the ERI alarm sounds and the pump reaches its 7-year end of service.
Customers were advised to forward the Urgent Medical Device Correction letter to patients whose name appears on their Pump Replacement List.
Reimbursement SupportFor assistance with prior authorization, contact Medtronic Reimbursement at the numbers below:
Therapy for Severe Spasticity: (800) 292-2903
Pain Therapies: (866) 962-9909
For questions regarding the letter call 800-328-0810.
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
Fluorometric, cortisol - Product Code JFT
Causa
Cortisol assay reagent kit lots do not meet onboard stability and calibration interval claims.
Acción
The firm, Siemens Healthcare, sent an "Urgent Field Safety Notice" via e-mail to all affected customers on March 6, 2012 in the United States and International. The Urgent Field Safety Notice describe the product, problem, and actions to be taken. The notice instructed the customers to perform daily calibration on all Cortisol reagent kits to maintain consistently accurate quality control and patient values; to complete and return the confirmation fax-back form 'Field Correction Effectiveness Check' via fax to the Technical Solutions Center at (302) 631-7597 and forward this notification to whomever they many have distributed this product.
If you have any questions, contact Quality Engineer 5- Quality Systems and Compliance at 508-660-8540 or www.siemens.com/diagnostics.
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.
An unnecessary dose refresh can occur in certain situations which causes inconsistencies in the beam doses and the total dose.
Acción
An "IMPORTANT SAFETY NOTICE" was issued between 3/5-9/12 via e-mail, FAX, or traditional mail. The Notice described the correct functioning of the system, the problem, when and why the issue occurs, the clinical impact, and the workaround. Patch 3.10.01 is now available. Customers can download their patch at the link provided in the Notice. The Notice also provided a list of offices where customers can contact if they have questions or further support is needed.
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
Immunohistochemistry reagents and kits - Product Code NJT
Causa
Reports of sporadic failure of specific lots of vina green chromogen kit, either through crystal formation that obscures positive staining, color not right, or a complete fading of staining by the chromogen.
Acción
"Medical Device Recall Notification" letters were sent on March 13, 2012 to all direct account. Letters informed customers of the reason for recall and the specific lots and catalog numbers involved, along with the reason for recall, how to identify the recalled product, and the actions to be taken. Customers were to immediately discontinue use of the affected product lot(s). They should dispose of the product according to national, state, and local laws and regulations. The enclosed Return Response Form should be completed and returned. Customers will be credited upon receipt of the Response Form.
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
Tape and bandage, adhesive - Product Code KGX
Causa
Packages of episeal wound closure strips and surgical kits containing them were recalled because the adhesive backing on episeal wound closure strips may not release from the backing rendering the product unusable.
Acción
DeRoyal Industries sent a Recall of Episeal Wound Closure Strip letter dated February 7, 2012, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer.
Customers were instructed to take the following action:
1. Please identify and quarantine any affected inventory using the product and lot numbers listed above.
2. Render affected product unusable, destroy and discard according to your facilitys guidelines.
3. If you are a distributor, forward this recall to any of your end users that may have affected product or provide us with the list and we will contact them.
4. Please complete the enclosed Notice of Destruction form, indicating the affected products you found in your inventory and destroyed. PLEASE COMPLETE AND RETURN THIS FORM EVEN IF YOU NO LONGER HAVE THE PRODUCT IN INVENTORY.
Return this form by fax (865-362-3716) or email (recalls@deroyal.com) within two weeks of the date of this letter. DeRoyal will use your response on the Notice of Destruction form to send replacements as soon as they become available.
If you have questions or need assistance with the recall, please contact DeRoyal Customer Support at 1-800-251-9864.
We apologize for inconvenience this may cause you
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.
Packages of episeal wound closure strips and surgical kits containing them were recalled because the adhesive backing on episeal wound closure strips may not release from the backing rendering the product unusable.
Acción
DeRoyal Industries sent a Recall of Episeal Wound Closure Strip letter dated February 7, 2012, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer.
Customers were instructed to take the following action:
1. Please identify and quarantine any affected inventory using the product and lot numbers listed above.
2. Render affected product unusable, destroy and discard according to your facilitys guidelines.
3. If you are a distributor, forward this recall to any of your end users that may have affected product or provide us with the list and we will contact them.
4. Please complete the enclosed Notice of Destruction form, indicating the affected products you found in your inventory and destroyed. PLEASE COMPLETE AND RETURN THIS FORM EVEN IF YOU NO LONGER HAVE THE PRODUCT IN INVENTORY.
Return this form by fax (865-362-3716) or email (recalls@deroyal.com) within two weeks of the date of this letter. DeRoyal will use your response on the Notice of Destruction form to send replacements as soon as they become available.
If you have questions or need assistance with the recall, please contact DeRoyal Customer Support at 1-800-251-9864.
We apologize for inconvenience this may cause you
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 (photometric, discrete), for clinical use - Product Code JJE
Causa
Ortho-clinical diagnostics is recalling vitros chemistry systems due to possible internal hard drive failure.
Acción
Ortho Clinical Diagnostics (OCD) sent an Important Product Correction Notification letter dated March 15, 2012 via FedEx overnight courier to all affected customers. Foreign affiliates were informed by email on 15 March 2012 of the issue and instructed to notify their consignees of the issue and actions. The letter identified the affected products, problem and actions to be taken. The letter instructed customers to: 1) Consider performing the backup procedure more frequently to help prevent the loss of data on your system; 2) Contact OCD Customer Technical Service representatives if a hard drive failure occurs on your system; A Field Engineer will be dispatched to replace the hard drive on your system; 3) Complete and return the Confirmation of Receipt form upon receipt of this notification; and 4) Post this notification by each VITROS¿ System in your facility or with the user documentation. For questions, refer to the Questions and Answers section. For additional questions, contact Customer Technical Services at 1-800-421-3311.
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 (photometric, discrete), for clinical use - Product Code JJE
Causa
Ortho-clinical diagnostics is recalling vitros chemistry systems due to possible internal hard drive failure.
Acción
Ortho Clinical Diagnostics (OCD) sent an Important Product Correction Notification letter dated March 15, 2012 via FedEx overnight courier to all affected customers. Foreign affiliates were informed by email on 15 March 2012 of the issue and instructed to notify their consignees of the issue and actions. The letter identified the affected products, problem and actions to be taken. The letter instructed customers to: 1) Consider performing the backup procedure more frequently to help prevent the loss of data on your system; 2) Contact OCD Customer Technical Service representatives if a hard drive failure occurs on your system; A Field Engineer will be dispatched to replace the hard drive on your system; 3) Complete and return the Confirmation of Receipt form upon receipt of this notification; and 4) Post this notification by each VITROS¿ System in your facility or with the user documentation. For questions, refer to the Questions and Answers section. For additional questions, contact Customer Technical Services at 1-800-421-3311.
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 (photometric, discrete), for clinical use - Product Code JJE
Causa
Ortho-clinical diagnostics is recalling vitros chemistry systems due to possible internal hard drive failure.
Acción
Ortho Clinical Diagnostics (OCD) sent an Important Product Correction Notification letter dated March 15, 2012 via FedEx overnight courier to all affected customers. Foreign affiliates were informed by email on 15 March 2012 of the issue and instructed to notify their consignees of the issue and actions. The letter identified the affected products, problem and actions to be taken. The letter instructed customers to: 1) Consider performing the backup procedure more frequently to help prevent the loss of data on your system; 2) Contact OCD Customer Technical Service representatives if a hard drive failure occurs on your system; A Field Engineer will be dispatched to replace the hard drive on your system; 3) Complete and return the Confirmation of Receipt form upon receipt of this notification; and 4) Post this notification by each VITROS¿ System in your facility or with the user documentation. For questions, refer to the Questions and Answers section. For additional questions, contact Customer Technical Services at 1-800-421-3311.
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 (photometric, discrete), for clinical use - Product Code JJE
Causa
Ortho-clinical diagnostics is recalling vitros chemistry systems due to possible internal hard drive failure.
Acción
Ortho Clinical Diagnostics (OCD) sent an Important Product Correction Notification letter dated March 15, 2012 via FedEx overnight courier to all affected customers. Foreign affiliates were informed by email on 15 March 2012 of the issue and instructed to notify their consignees of the issue and actions. The letter identified the affected products, problem and actions to be taken. The letter instructed customers to: 1) Consider performing the backup procedure more frequently to help prevent the loss of data on your system; 2) Contact OCD Customer Technical Service representatives if a hard drive failure occurs on your system; A Field Engineer will be dispatched to replace the hard drive on your system; 3) Complete and return the Confirmation of Receipt form upon receipt of this notification; and 4) Post this notification by each VITROS¿ System in your facility or with the user documentation. For questions, refer to the Questions and Answers section. For additional questions, contact Customer Technical Services at 1-800-421-3311.
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.
Christie Medical Holdings, Inc. sent an Urgent Medical Device Correction by letter on March 14, 2012 to all affected customers. The letter identified the product, problem and actions to be taken. The letter includes "Correct Transport" and "Do Not Pull labels to be applied to the unit. Customers were instructed to immediately examine their inventory, quarantine all product subject to correction and apply the labels prior to use. A Service Bulletin is enclosed that should be kept and placed with the User Guide for future reference and a Response Form to be completed and return as soon as possible. For questions contact Technical Service at 901-721-0300.
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
Container, empty, for collection & processing of blood & blood components - Product Code KSR
Causa
Device's needle may become dislodged from the cup during shipment or during use.
Acción
DeRoyal Industries sent Recall communication by letter to all affected consignees of the Non-Sterile Bulk and Single Sterile Units on January 20, 2012 and of the Kits and Trays on Febraury 6, 2012. The letters identified the affected products, problem and actions to be followed. Customers were instrructed to complete the enclosed Notice of Destruction form and return this form by fax (865-362-3716) or email (recalls@deroyal.com) within two weeks of the date of this letter. DeRoyal will use your response on the Notice of Destruction form to send replacements as soon as they become available. Distributors were instructed to forward this recall to any of their end users that may have affected product.
If you have questions or need assistance with the recall, please call 865.362.1020 or Robby Lockett at 865.362.1034.
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
Tray, surgical - Product Code LRP
Causa
Device's needle may become dislodged from the cup during shipment or during use.
Acción
DeRoyal Industries sent Recall communication by letter to all affected consignees of the Non-Sterile Bulk and Single Sterile Units on January 20, 2012 and of the Kits and Trays on Febraury 6, 2012. The letters identified the affected products, problem and actions to be followed. Customers were instrructed to complete the enclosed Notice of Destruction form and return this form by fax (865-362-3716) or email (recalls@deroyal.com) within two weeks of the date of this letter. DeRoyal will use your response on the Notice of Destruction form to send replacements as soon as they become available. Distributors were instructed to forward this recall to any of their end users that may have affected product.
If you have questions or need assistance with the recall, please call 865.362.1020 or Robby Lockett at 865.362.1034.
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
Container, empty, for collection & processing of blood & blood components - Product Code KSR
Causa
Device's needle may become dislodged from the cup during shipment or during use.
Acción
DeRoyal Industries sent Recall communication by letter to all affected consignees of the Non-Sterile Bulk and Single Sterile Units on January 20, 2012 and of the Kits and Trays on Febraury 6, 2012. The letters identified the affected products, problem and actions to be followed. Customers were instrructed to complete the enclosed Notice of Destruction form and return this form by fax (865-362-3716) or email (recalls@deroyal.com) within two weeks of the date of this letter. DeRoyal will use your response on the Notice of Destruction form to send replacements as soon as they become available. Distributors were instructed to forward this recall to any of their end users that may have affected product.
If you have questions or need assistance with the recall, please call 865.362.1020 or Robby Lockett at 865.362.1034.
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
Pump, infusion, insulin - Product Code LZG
Causa
There is an error in the pump software where the onetouch(r) ping(r) insulin pump did not allow the user to save changes to the time and date on the pump if those changes were made on february 29, 2012 (leap day). users who did not attempt to change the time or date on their pump on february 29, 2012 are not affected by this issue.
Acción
The firm initiated their recall on March 1, 2012 and sent Urgent Notification letters dated March 6, 2012 to all consignees by UPS with delivery confirmation. Customers were notified of the issue and the appropriate steps to take in order to mitigate the issue. A Web Letter for users was also posted to the Animas web site. Questions were directed to (855) 230-7577.
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.
Terumo cvs has received reports of 27 instances in which the 6 inch roller pump jammed during cardioplegia delivery. there has been one report of the pump jamming during a case that concluded with an adverse patient outcome, although there was no indication that the pump jam contributed to the adverse patient outcome.
Acción
"URGENT MEDICAL DEVICE RECALL" letters were sent on 3/16/12 to all consignees detailing the correction as well as also adding an Addendum to the Operator's manual for the Terumo System 1 to incorporate additional information and warnings for use when operating a 6" roller pump with dual-sized tubing. For questions call 1-800-521-2818.
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.
Mislabeled: vial lid label on some of the dental implant vials from this lot incorrectly state 04.8 sp 10 rn instead of 04.8 sp 10 wn.
Acción
Straumann sent a "FIELD CORRECTIVE ACTION NOTICE" dated March 12, 2012 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. The letter instructs customers to check their inventory for the affected product and to return any affected product to the firm. Additionally, a Customer Confirmation Form was enclosed for customers to complete and return. Contact the firm at 978-747-2514 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
Test, sickle cell - Product Code GHM
Causa
Two complaints concerning the powder vial included in the 100 test kit has been observed producing pressure while sealed. when the powders are opened, the pressure from within the vial releases a small amount of powder into the air.
this powder. if released near the face and inhaled can cause minor irritation resulting in sneezing and nasal
congestion. investigation found no affect on the perf.
Acción
Michclone Associates, Inc. sent an "URGENT MEDICAL DEVICE RECALL" letter dated March 15, 2012 to all affected customers. The letter identifies the product, problem, and actions to be taken by the customers. The letter instructs customers to identify affected lots, notify sub accounts, and complete and return the response form to arrange return of unused product and replacement . Forms can be returned by FAX 248(307)-9498, mail: Michclone Associates Inc. 680 Ajax Drive, Madison Heights, MI 48118 or Email: toben@greatlakesdiag.com. Questions and concerns should be addressed to Technical Support Department at 248-307-9494.
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.
Depuy orthopaedics, inc. is issuing a recall notice for nine lots of the attune" impaction handle due to the potential for the handle trigger to break during surgery. the attune impactor is provided as a part of a set of tools and is designed specifically for the installation of the attune knee.
Acción
DePuy Orthopaedics, Inc. sent an URGENT INFORMATION - MEDICAL DEVICE RECALL NOTICE letter dated March 16, 2012 to all consignees affected which extended to the Depuy Distributor level, surgeon and hospital level. The affected DePuy Distributors were notified via email on March 16, 2012. The sales representatives notify hospitals and surgeons by mail or in person with written communication. The letter identified the affected product, reason for recall notice, clinical implications and actions to be taken. Consignees were instructed to complete and return the Response cards to DePuy by fax to 574-372-7567 or email to:kseppa@its.jnj.com. When the new impaction handles are available, the DePuy sales representative will be responsible for providing the new handles, removing and returning the affected handles.
For product-related questions, please contact your local DePuy Orthopaedics sales representative. For clinical-related questions from surgeons, please contact DePuy's Scientific Information Office at 1-888-554-2482 (M-F; 8 am - 5 pm EST.) For questions about recall information provided, please contact Katie Seppa, Manager of Customer Quality, 574-372-7333 (M-F; 8 am - 5 pm EST.)
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, x-ray, tomography, computed - Product Code JAK
Causa
Philips healthcare is performing an upgrade to the field for issues related to philips brilliance 64 and ingenuity ct scanner having software version 3.5.1. when the user plans a scan with tilt applied, the scan increment changes from the user defined values (noncontiguous) to a contiguous scan.