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
Causa
Medtronic has identified a software anomaly that can prevent the internal battery of the pump from charging. when the software anomaly occurs it leads to battery depletion and pump shutdown.
Acción
A urgent medical device recall letter was sent to customers on 1/31/17 to inform them that Medtronic has identified a software issue that could prevent the internal battery of the pump from charging. Customers are informed that should the software issue occur, an alarm is triggered and they will see the following message displayed on the pump screen: "Power error detected 00:00 25 Delivery stopped. Record your settings by uploading to CareLink or write your settings on paper. See user guide. OK." Customers are informed that If they experience the alarm and see the Power error detected message on their pump accompanied by the number 25 , then they are instructed to contact the Medtronic HelpLine team at XXXXX for assistance with troubleshooting the error.
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
Flame photometry, lithium - Product Code JIH
Causa
Intermittent imprecision in results generated using two specific lots of vitros li slides.
Acción
On 2/01/ 2017, URGENT PRODUCT CORRECTION NOTIFICATION letter (Ref. CL2017-036, dated 2/01/2017) was sent via FedEx overnight courier and/ or ORTHO PLUS e-Communications and/ or US Postal Service Priority Mail (for PO Boxes only) to all customers who received the affected VITROS Chemistry Products Li Slides to inform them of the issue and to request that they immediately discontinue use of this product. The correction is to the user level. Discuss any concerns regarding previously reported VITROS Li results obtained from the affected with their Laboratory's Medical Director to determine the appropriate course of action. Ortho will be shipping replacement product. ---Foreign affiliates were informed of the issue by e-mail on 2/01/2017 and instructed to notify their consignees of the affected product with this issue and the requirement to immediately discontinue use of the product. For questions, please contact our Ortho Care(TM) Technical Solutions Center 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.
Carefusion is recalling the maxguard extension set with injection site and 0.2 micron filter because of reports of separation and/or leakages between the y-connector and tubing.
Acción
An Urgent Medical Device Recall Notification letter will be sent to customers on February 20, 2017 to inform them that CareFusion is recalling the MaxGuard Extension Set with Injection Site and 0.2 micron filter
model number ME3305 Lot Number 16016790. Customers are informed that CareFusion has received reports of separation and/or leakages between theY-connector and tubing. Customers are informed that leakages from an extension set can cause delay of infusion, interruption of infusion, exposure to medication or hazardous infusates, or underinfusion. The letter informs the customers of the actions to be taken and for recall related questions to contact CareFusion Support Center at (888) 562-6018. Customers with adverse event reports are instructed to contact customer advocacy at (888) 812-3266.
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
General surgery tray - Product Code LRO
Causa
Custom procedure trays contain a component, a light glove, that has been recalled by the manufacturer because it can split during application to a light handle breaking the sterile field.
Acción
ROi sent an Urgent Recall Notice dated January 9, 2017, to all affected consignees. The recalling firm instructed consignees to quarantine affected product and complete the response form. The recalling firm stated that they will issue over lableing for the affected packs. Sterile replacement light covers will be sent directly to the end user if available. Consignees were instructed to inform their subaccounts of the recall. For questions regarding this recall call 417-820-2793.
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.
Carefusion is recalling the maxguard extension set due to reports of leaks occurring with the 0.2 micron filter.
Acción
CareFusion sent an Urgent Medical Device Recall Notification letter dated February 2017 to all affected customers inform them that CareFusion is recalling the MaxGuard Extension Set model codes ME20164, MP9009-C, MP9209, MP9254-C with multiple lot numbers. CareFusion has received reports of leaks occurring with the 0.2 micron filter. Customers were informed that leakages on an extension can cause delay of infusion, interruption of infusion, exposure to medication or hazardous infusates, underinfusion or air in line. Customers were instructed to discontinue use of the affected product and contact CareFusion for a replacement lot. The letter informs the customers of the actions to be taken and for recall related questions to contact CareFusion Support Center at (888) 562-6018. Customers with adverse event reports are instructed to contact Customer Advocacy at (888) 812-3266. Customers were also instructed to immediately complete and return to CareFusion the enclosed, pre-addressed and postage paid, Recall Response Card.
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.
Digital templates were created with the incorrect files.
Acción
On 2/14/2017 URGENT MEDICAL DEVICE CORRECTION notifications were sent to the affected users and 3rd party users via email. The recall notification included a description of the reason for the recall, affected product, consignee responsibilities, and instructions for 3rd party users to respond to the formal recall notification.
Orthosize Templating Users
In approximately 6 weeks you will receive a notice that an update is available for the Orthosize Templating App. Upon selecting the app you will be required to update the app in order to use it.
1. Review this notification and ensure affected personnel are aware its contents.
2. Immediately update the app when the update becomes available.
3. If after reviewing this notice you have further questions or concerns please call 411 Technical
Services at 574-371-3071 between 8:00 am and 5:00pm EST, Monday through Friday.
Alternatively, your
questions may be sent by email to corporatequality.postmarket@zimmerbiomet.com
Digital Template Users (3rd party)
1. Review this notification and ensure affected personnel are aware of the contents.
2. Immediately update your systems to include the revised digital templates included with notice.
3. Complete Attachment 1 Certificate of Acknowledgement.
a. Return a digital copy to corporatequality.postmarket@zimmerbiomet.com.
b. Retain a copy of the Acknowledgement Form with your records.
4. If after reviewing this notice you have further questions or concerns please call 411 Technical
Services at 574-371-3071 between 8:00 am and 5:00pm EST, Monday through Friday. Calls
received outside of the call center operating hours will receive a prompt to record a voicemail or
be transferred to an on-call representative in the case of an emergency. Alternatively, your
questions may be sent by email to corporatequality.postmarket@zimmerbiomet.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
Culture media, antimicrobial susceptibility test - Product Code LKA
Causa
Test organisms exhibit poor growth when grown using the test agar. the poor growth can give users incorrect ast zones when performing susceptibility tests.
Acción
Thermo Fisher sent an Urgent Medical Device Recall letter dated February 9, 2017, to all affected customers. The recalling firm issued written notifications to their customers. Customers were instructed to destroy any remaining inventory of the recalled lots. Customers were also instructed to contact everyone within their organization or any other organization where the devices have been transferred. An acknowledgement form was included with the recall notice. Customers were asked to complete the acknowledgement form and return it to the recalling firm.
If you have any questions, please contact our Technical Service Department at (800) 255-6730 ( US ) or (913) 888-0939 ( International)
For further questions, please call (913) 895-4077.
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
Device, hemostasis, vascular - Product Code MGB
Causa
Abbott vascular is recalling the starclose se vascular closure system because it may exhibit difficulty or failure to deploy the starclose se clip.
Acción
An urgent field safety notice will be sent to customers on 2/10/17 to inform them that Abbott Vascular has initiated a recall regarding specific lots of the StarClose SE Vascular Closure System. Customers are informed that product from the identified lots may exhibit difficulty or failure to deploy the StarClose SE Clip. Potential risks associated with this event include prolonged procedure times, use of another device or manual compression to achieve hemostasis. Customers are instructed of the actions to be taken and what Abbott Vascular is doing about the recall. Customers with any questions are instructed to contact their local Abbott Vascular Representative or Customer Service Department at (800) 227-9902.
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
Accelerator, linear, medical - Product Code IYE
Causa
Siemens became aware of incorrect values for the rotational collimator position displayed due to mechanical problems of the sensor slide. in addition, there are improper weld seam at the overhead suspension.
Acción
Siemens mailed a Customer Safety Advisory Notice (CSAN) dated February 7, 2017 to affected customers. The letter identified the affected product, problem and actions to be taken. The letter stated that Siemens will contact customers to arrange a date for the installation of the software update.
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 initiated a voluntary recall for the level sensor ii pads and level sensor gel pads due to non-compliant labeling because the product expiration date is displayed in a format that may not be recognizable to all users.
Acción
Terumo CVS initiated a voluntary recall by issuing a safety advisory for their Terumo Advanced Perfusion System 1-Level Sensor II Pads, and Terumo Advanced Perfusion System 1-Level Sensor II Gel Pads due to non-compliant labeling because the product expiration date is displayed in a format that may not be recognizable to all users. Customers are asked to do the following:
1. Review the Safety Advisory.
2. Assure that all users receive notice of this issue.
3. Confirm receipt of this Safety Advisory by emailing or faxing the attached Customer Response Form to the email address or fax number indicated on the form.
For questions contact Terumo CVS at 1-800-521-2818, Monday Friday, 8 a.m. 6 p.m. ET. Any adverse events experienced with the use of this product, and/or quality problems should also be reported to the FDAs MedWatch Program:
Phone: 1.800.FDA.1088 Fax: 1.800.FDA.0178, Web: www.fda.gov/medwatch/report.htm MedWatch Online Voluntary Reporting Form (mail to address on form): www.fda.gov/Safety/MedWatch/HowtoReport
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 initiated a voluntary recall for the level sensor ii pads and level sensor gel pads due to non-compliant labeling because the product expiration date is displayed in a format that may not be recognizable to all users.
Acción
Terumo CVS initiated a voluntary recall by issuing a safety advisory for their Terumo Advanced Perfusion System 1-Level Sensor II Pads, and Terumo Advanced Perfusion System 1-Level Sensor II Gel Pads due to non-compliant labeling because the product expiration date is displayed in a format that may not be recognizable to all users. Customers are asked to do the following:
1. Review the Safety Advisory.
2. Assure that all users receive notice of this issue.
3. Confirm receipt of this Safety Advisory by emailing or faxing the attached Customer Response Form to the email address or fax number indicated on the form.
For questions contact Terumo CVS at 1-800-521-2818, Monday Friday, 8 a.m. 6 p.m. ET. Any adverse events experienced with the use of this product, and/or quality problems should also be reported to the FDAs MedWatch Program:
Phone: 1.800.FDA.1088 Fax: 1.800.FDA.0178, Web: www.fda.gov/medwatch/report.htm MedWatch Online Voluntary Reporting Form (mail to address on form): www.fda.gov/Safety/MedWatch/HowtoReport
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
Accelerator, linear, medical - Product Code IYE
Causa
Siemens became aware of a defective weld seam at overhead suspensions. due to this defect it is possible for the weld seam to break and to cause the overhead suspension to fall down. this can lead to a severe injury to a patient or any other person.
Acción
Siemens sent a Customer Safety Advisory Notice (CSAN) dated February 7, 2017, to affected customers to inform them of a planned hardware update regarding the mechanics of the overhead suspension of their Digital Linear Accelerator. The notice also explained the actions Siemens is taking to perform the necessary fix at the affected sites. Customers were advised to notify anyone at their organization that should be aware of this information. Also, the safety notice should be forwarded to the new owner and Siemens also requested they be informed of the identity of the device's new owner where possible. Customers with questions were instructed to call 1-800-888-7436. For questions regarding this recall call 610-448-6478.
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
Accelerator, linear, medical - Product Code IYE
Causa
Siemens became aware of a defective weld seam at overhead suspensions. due to this defect it is possible for the weld seam to break and to cause the overhead suspension to fall down. this can lead to a severe injury to a patient or any other person.
Acción
Siemens sent a Customer Safety Advisory Notice (CSAN) dated February 7, 2017, to affected customers to inform them of a planned hardware update regarding the mechanics of the overhead suspension of their Digital Linear Accelerator. The notice also explained the actions Siemens is taking to perform the necessary fix at the affected sites. Customers were advised to notify anyone at their organization that should be aware of this information. Also, the safety notice should be forwarded to the new owner and Siemens also requested they be informed of the identity of the device's new owner where possible. Customers with questions were instructed to call 1-800-888-7436. For questions regarding this recall call 610-448-6478.
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, Orbital, Extra-Ocular - Product Code HQX
Causa
Lack of sterility assurance.
Acción
The recalling firm issued letters to the accounts requesting the return of the devices.
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
Accelerator, linear, medical - Product Code IYE
Causa
Siemens became aware of a defective weld seam at overhead suspensions. due to this defect it is possible for the weld seam to break and to cause the overhead suspension to fall down. this can lead to a severe injury to a patient or any other person.
Acción
Siemens sent a Customer Safety Advisory Notice (CSAN) dated February 7, 2017, to affected customers to inform them of a planned hardware update regarding the mechanics of the overhead suspension of their Digital Linear Accelerator. The notice also explained the actions Siemens is taking to perform the necessary fix at the affected sites. Customers were advised to notify anyone at their organization that should be aware of this information. Also, the safety notice should be forwarded to the new owner and Siemens also requested they be informed of the identity of the device's new owner where possible. Customers with questions were instructed to call 1-800-888-7436. For questions regarding this recall call 610-448-6478.
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
Accelerator, linear, medical - Product Code IYE
Causa
Siemens became aware of a defective weld seam at overhead suspensions. due to this defect it is possible for the weld seam to break and to cause the overhead suspension to fall down. this can lead to a severe injury to a patient or any other person.
Acción
Siemens sent a Customer Safety Advisory Notice (CSAN) dated February 7, 2017, to affected customers to inform them of a planned hardware update regarding the mechanics of the overhead suspension of their Digital Linear Accelerator. The notice also explained the actions Siemens is taking to perform the necessary fix at the affected sites. Customers were advised to notify anyone at their organization that should be aware of this information. Also, the safety notice should be forwarded to the new owner and Siemens also requested they be informed of the identity of the device's new owner where possible. Customers with questions were instructed to call 1-800-888-7436. For questions regarding this recall call 610-448-6478.
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
Accelerator, linear, medical - Product Code IYE
Causa
Siemens became aware of a defective weld seam at overhead suspensions. due to this defect it is possible for the weld seam to break and to cause the overhead suspension to fall down. this can lead to a severe injury to a patient or any other person.
Acción
Siemens sent a Customer Safety Advisory Notice (CSAN) dated February 7, 2017, to affected customers to inform them of a planned hardware update regarding the mechanics of the overhead suspension of their Digital Linear Accelerator. The notice also explained the actions Siemens is taking to perform the necessary fix at the affected sites. Customers were advised to notify anyone at their organization that should be aware of this information. Also, the safety notice should be forwarded to the new owner and Siemens also requested they be informed of the identity of the device's new owner where possible. Customers with questions were instructed to call 1-800-888-7436. For questions regarding this recall call 610-448-6478.
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
Accelerator, linear, medical - Product Code IYE
Causa
Siemens became aware of a defective weld seam at overhead suspensions. due to this defect it is possible for the weld seam to break and to cause the overhead suspension to fall down. this can lead to a severe injury to a patient or any other person.
Acción
Siemens sent a Customer Safety Advisory Notice (CSAN) dated February 7, 2017, to affected customers to inform them of a planned hardware update regarding the mechanics of the overhead suspension of their Digital Linear Accelerator. The notice also explained the actions Siemens is taking to perform the necessary fix at the affected sites. Customers were advised to notify anyone at their organization that should be aware of this information. Also, the safety notice should be forwarded to the new owner and Siemens also requested they be informed of the identity of the device's new owner where possible. Customers with questions were instructed to call 1-800-888-7436. For questions regarding this recall call 610-448-6478.
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 contains latex symbol was not printed onto the box label or the sterile (inner) product pouch.
Acción
LeMaitre Vascular, Inc. issued a Dear Doctor letter, on 2/7/17, to distributors and hospitals via FedEx overnight. The letter contains a form that is requested to be returned to LeMaitre Vascular, Inc. as a record of notification and reconciliation. Any unused product requested to be returned and replaced.
Questions concerning this notice contact 781-221-2266 ext. 183.