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
Kit, i.V. Start - Product Code LRS
Causa
Compromised sterility due to breach of barrier.
Acción
Covidien initiated recall by letter on March 4, 2016. Customers were notified via Federal Express and the letter instructs customers to discontinue use of the product and return all inventory to Medtronic (Covidien), 195 McDermott Road, North Haven, CT 06473, Attention: Field Returns Department.
Any questions or concerns, contact your Medtronic representative or Customer Service at (800) 882-5878
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
Kit, i.V. Start - Product Code LRS
Causa
Compromised sterility due to breach of barrier.
Acción
Covidien initiated recall by letter on March 4, 2016. Customers were notified via Federal Express and the letter instructs customers to discontinue use of the product and return all inventory to Medtronic (Covidien), 195 McDermott Road, North Haven, CT 06473, Attention: Field Returns Department.
Any questions or concerns, contact your Medtronic representative or Customer Service at (800) 882-5878
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
Kit, i.V. Start - Product Code LRS
Causa
Compromised sterility due to breach of barrier.
Acción
Covidien initiated recall by letter on March 4, 2016. Customers were notified via Federal Express and the letter instructs customers to discontinue use of the product and return all inventory to Medtronic (Covidien), 195 McDermott Road, North Haven, CT 06473, Attention: Field Returns Department.
Any questions or concerns, contact your Medtronic representative or Customer Service at (800) 882-5878
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
Kit, i.V. Start - Product Code LRS
Causa
Compromised sterility due to breach of barrier.
Acción
Covidien initiated recall by letter on March 4, 2016. Customers were notified via Federal Express and the letter instructs customers to discontinue use of the product and return all inventory to Medtronic (Covidien), 195 McDermott Road, North Haven, CT 06473, Attention: Field Returns Department.
Any questions or concerns, contact your Medtronic representative or Customer Service at (800) 882-5878
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
The two sets of wires (4 total wires) exiting from the emi filters were switched, creating a situation where a module that is intended to be de-energized will remain energized only if the associated ac power cord is unplugged.
Acción
On February 16, 2016, Ortho Clinical Diagnostics distributed Urgent Product Correction Notification notices to their customers via FedEx overnight courier, e-communications and via USPS. Customers are advised that there is no impact to the results generated with an affected system. As a precaution, your Ortho-trained service representative will contact you to schedule an inspection of the wiring within the system at your facility. Following the inspection, reconfiguration of the wiring on your system will be performed if appropriate. Please store a copy of the notification with your user documentation until the wires within your system(s) are inspected. In addition, complete the receipt form to indicate that you have been informed of this anomaly. Please return the form to Joe Falvo via email at confirmationadmin@its.jnj.com or via fax to 1-888-557-3759 or 1-585-453-4110. Customers with questions can contact the Technical Solutions Center at 1-800-421-3311 anytime.
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
Mass spectrometer, clinical use - Product Code DOP
Causa
Wrong quantitative results may be displayed in a report from the device, which may potentially lead to an incorrect patient diagnosis.
Acción
Sciex sent an Urgent Medical Device Correction letter dated February 29, 2016, to all affected US customers via Fedex on March 2, 2016. International customers were notified beginning on March 3, 2016. The letter informed customers of the issue and requests that they take temporary steps to eliminate the potential for erroneous events. In addition, a software update is in development and is expected to be available in approximately 4 weeks. Customers with questions were instructed to contact SCIEX at 1-289-982-2531.
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.
Alcon is conducting a voluntary medical device correction of all verion reference units (vision planner) that are shared with the alcon lensx laser system after receiving reports concerning the inclusion of unplanned arcuates on printed, saved (.Pdf) or exported surgical plans.
Acción
Alcon sent an Urgent Medical Device Correction letter dated February 29, 2016 to affected customers. The letter identified the affected product, problem and actions to be taken. The letter stated that an Alcon Technical Services Engineers will contact customers, schedule Service Calls, and perform onsite corrections. For questions call 1-800-862-5266.
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.
Baxter healthcare corporation is sending this communication to inform you of incomplete instructions in the amia automated peritoneal dialysis (po) system clinician guide for calculating the total recommended solution therapy volume. specifically, the instructions do not specify the need for an extra 200 ml of pd solution in order to prime the patient line and for air purge operations.
the tot.
Acción
An Urgent Device Correction communication was sent to the one affected customer via U.S.P.S., first class mail on 02/11/2016.
A Clinician Guide Addendum was created to instruct clinicians of the extra 200 mL of PD solution required to prime the patient line and for air purge operations. This Addendum was provided as an attachment to the Urgent Device Correction communication 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
System, test, human chorionic gonadotropin - Product Code DHA
Causa
When testing was conducted using certain lots, vitros¿ systems generated results within the measuring range for samples known to not contain measurable hcg. the system reported results up to approximately 7.40 miu/ml (iu/l) for patient samples that should have been less than the measuring range of the assay (<2.39 miu/ml (iu/l)).
Acción
On February 18, 2016, Ortho Clinical Diagnostics distributed Urgent Product Correction Notification letters and Confirmation of Receipt Forms to their customers (Ref. CL2016-043) via FedEx overnight courier and/ or ORTHO PLUS e-Communications and/ or US Postal Service Priority Mail. Customers are advised to immediately discontinue using and discard all remaining inventory of the listed lots. Ortho Clinical Diagnostics will replace all remaining inventory or provide account credits as indicated on the confirmation of receipt form. Customers are advised to review previously reported results using the affected lots and to discuss these findings with your Laboratory Medical Director to determine the appropriate course of action. Post the notification by your VITROS System or with your user documentation. Complete and return the Confirmation of Receipt form to Joe Falvo via email at confirmationadmin@its.jnj.com or by fax to 1-888-557-3759 or to 1-585-453-4110. Clients with questions can contact Customer Technical Services at 1-800-421-3311 at any time.
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
duodenoscope and accessories, flexible/rigid - Product Code FDT
Causa
This correction is in response to publicized reports of multi-drug resistant bacteria on endoscopes used for endoscopic retrograde cholangiopancreatogram (ercp) procedures.
Acción
Fujifilm issued a urgent field correction/Tracking/Verification form on 12/23/2015.
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
Sirolimus test system - Product Code NRP
Causa
Siemens healthcare diagnostics has received customer complaints regarding qc shifts and imprecision after one day when using dimension¿ siro lot eb6064. they have confirmed siro lot # eb6064 does not meet the open well stability claim of 2 days.
Acción
Siemens sent an "URGENT MEDICAL DEVICE RECALL" letter dated February 2016, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer.
Actions to be Taken by the Customer:
Discontinue use of and discard the kit lot listed in Table 1.
Please review this letter with your Medical Director.
Complete and return the Field Correction Effectiveness Check Form attached to this letter within 30 days.
If you have received any complaints of illness or adverse events associated with the product listed in Table 1, immediately contact your local Siemens Customer Care Center or your local Siemens technical support representative.
Please retain this letter with your laboratory records, and forward this letter to those who may have received this product.
We apologize for the inconvenience this situation may cause. If you have any questions, please contact your Siemens Customer Care Center or your local Siemens technical support representative. For further questions, please call (302) 631-0528.
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, ablation, microwave and accessories - Product Code NEY
Causa
Medtronic is voluntarily recalling specific item codes and production lots of covidien emprint" percutaneous antenna with thermosphere" technology due to the potential for the generator to shut down in the precence of high temperature measurements in the emprint" percutaneous antenna.
Acción
Medtronic sent an Urgent Medical Device Recall letter dated February 23, 2016 to all affected customers via Federal Express or Certified Mail. The letter identified the affected product, problem and actions. Customers were advised to quarantine and discontinue use of the affected product and to Return product. For questions or concerns, contact your Medtronic representative or Customer Service at (800) 882-5878.
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
Implant, endosseous, root-form - Product Code DZE
Causa
Implant direct sybron manufacturing, llc is recalling godirect implants because some consignees did not receive the correct tool to drive the implant to bone level.
Acción
Implant Direct sent an Urgent: Medical Device Field Corrective Action letter dated March 4, 2016, to all affected customers. The letter states that Implant Direct will correct the issue and send the proper tool. The proper tool is included with the notification. The letter requests that customers complete and return the Acknowledgement and Recall Return Form within 48 hours.
It customers are an authorized Implant Direct Sybron Manufacturing distributor it is requested that customers are identified and contact them to inform them of the issue within 48 hours of receiving the notification. Distributors should also provide customers with the correct tool.
If you have any of the affected product listed above and have any questions contact Implant Direct Sybron Manufacturing LLC Customer Care at 1-888-649-6425.
For further questions regarding this please call (818) 444-3300 Ext. 3323
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.
Mckesson has identified a design deficiency where under rare circumstances, imported images/studies may re-use a non-unique image directory. this issue may cause incorrect images to be displayed for a patient.
Acción
McKesson sent an Urgent Field Safety Notice dated February 18, 2016, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer.
Immediate actions to take to reduce the risk to patient
All customers receiving this safety notice must contact McKesson Support as soon as possible at 1-800-663-2533 US/Canada and International Toll Free Radiology - 00 800 626 20009:
1) To acknowledge that they have read and understood this Field Safety Notice
And
2) Arrange installation of software update/upgrade.
This notice should be distributed to all personnel within your organization who need to be aware of this issue and the required actions, and alert other affiliated parties that are affected by this Field Safety Notice.
For further questions, please call (404) 338-3556
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, thermal regulating - Product Code DWJ
Causa
Complaints were received of restricted/inaccurate flow rate.
Acción
Bard Medical sent an Urgent Medical Product Recall letter dated March 4, 2016 to affected customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to not use any of the affected products and to return any unused product Bard Medical Division via the provided Customer Recall and Effectiveness Form. BMD will be providing a replacement for the returned product. If the product was further distributed, the consignee was instructed to identify their customers and notify them of the product recall.
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
Clip, hemostatic - Product Code MCH
Causa
Applied medical resources corporation is recalling ca500 epix universal clip applier, kit models std gk258 ame standard kit 44, std kit gk213, ame standard kit 15, and std kit gk260, standard set 360 z, which contain the affected ca500 lot, because of a potential loading mechanism nonconformance.
Acción
Customer notification letters were sent on December 22, 2015 for the U.S. and on January 6, 2016 for those in Europe.
The customer notification letter requested that the following actions be taken:
- Check inventory for recalled product.
- Complete the attached Recall Notification Confirmation Form to acknowledge the
recall, indicate if facility is returning or has already used this lot, and provide a no-charge PO number if replacements requested.
- Return the Recall Notification Confirmation Form to Applied Medical by emailing to
recall60684384@appliedmedical.com or faxing to (949) 713-8936.
- Return affected product and a copy of the Recall Notification Confirmation Form to Applied Medical
For product return questions contact Karen Mitchell, Sales Operations Supervisor, RGA Dept. at (949) 713-8622 or by email at kmitchell@appliedmedical.com.
For regulatory questions contact Lauren Contursi, at (949) 713-8767 or by email at lcontursi@appliedmedical.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
Clip, hemostatic - Product Code MCH
Causa
Applied medical resources corporation is recalling ca500 epix universal clip applier, kit models std gk258 ame standard kit 44, std kit gk213, ame standard kit 15, and std kit gk260, standard set 360 z, which contain the affected ca500 lot, because of a potential loading mechanism nonconformance.
Acción
Customer notification letters were sent on December 22, 2015 for the U.S. and on January 6, 2016 for those in Europe.
The customer notification letter requested that the following actions be taken:
- Check inventory for recalled product.
- Complete the attached Recall Notification Confirmation Form to acknowledge the
recall, indicate if facility is returning or has already used this lot, and provide a no-charge PO number if replacements requested.
- Return the Recall Notification Confirmation Form to Applied Medical by emailing to
recall60684384@appliedmedical.com or faxing to (949) 713-8936.
- Return affected product and a copy of the Recall Notification Confirmation Form to Applied Medical
For product return questions contact Karen Mitchell, Sales Operations Supervisor, RGA Dept. at (949) 713-8622 or by email at kmitchell@appliedmedical.com.
For regulatory questions contact Lauren Contursi, at (949) 713-8767 or by email at lcontursi@appliedmedical.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
Clip, hemostatic - Product Code MCH
Causa
Applied medical resources corporation is recalling ca500 epix universal clip applier, kit models std gk258 ame standard kit 44, std kit gk213, ame standard kit 15, and std kit gk260, standard set 360 z, which contain the affected ca500 lot, because of a potential loading mechanism nonconformance.
Acción
Customer notification letters were sent on December 22, 2015 for the U.S. and on January 6, 2016 for those in Europe.
The customer notification letter requested that the following actions be taken:
- Check inventory for recalled product.
- Complete the attached Recall Notification Confirmation Form to acknowledge the
recall, indicate if facility is returning or has already used this lot, and provide a no-charge PO number if replacements requested.
- Return the Recall Notification Confirmation Form to Applied Medical by emailing to
recall60684384@appliedmedical.com or faxing to (949) 713-8936.
- Return affected product and a copy of the Recall Notification Confirmation Form to Applied Medical
For product return questions contact Karen Mitchell, Sales Operations Supervisor, RGA Dept. at (949) 713-8622 or by email at kmitchell@appliedmedical.com.
For regulatory questions contact Lauren Contursi, at (949) 713-8767 or by email at lcontursi@appliedmedical.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
Clip, hemostatic - Product Code MCH
Causa
Applied medical resources corporation is recalling ca500 epix universal clip applier, kit models std gk258 ame standard kit 44, std kit gk213, ame standard kit 15, and std kit gk260, standard set 360 z, which contain the affected ca500 lot, because of a potential loading mechanism nonconformance.
Acción
Customer notification letters were sent on December 22, 2015 for the U.S. and on January 6, 2016 for those in Europe.
The customer notification letter requested that the following actions be taken:
- Check inventory for recalled product.
- Complete the attached Recall Notification Confirmation Form to acknowledge the
recall, indicate if facility is returning or has already used this lot, and provide a no-charge PO number if replacements requested.
- Return the Recall Notification Confirmation Form to Applied Medical by emailing to
recall60684384@appliedmedical.com or faxing to (949) 713-8936.
- Return affected product and a copy of the Recall Notification Confirmation Form to Applied Medical
For product return questions contact Karen Mitchell, Sales Operations Supervisor, RGA Dept. at (949) 713-8622 or by email at kmitchell@appliedmedical.com.
For regulatory questions contact Lauren Contursi, at (949) 713-8767 or by email at lcontursi@appliedmedical.com.