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
Interventional fluoroscopic x-ray system - Product Code OWB
Causa
The use of allura xper, allura clarity, allura cv, allura centron and uniq systems regarding live images and still images can lead to still images being interpreted as live images.
Acción
The firm, Philips, issued "URGENT-Field Safety Notices" dated 10/26/2015 and 11/19/2015 to its customers. The notices described the product, problem and actions to be taken. The customers were instructed to ensure the audible signal (X-ray buzzer) is always enabled, to activate only ONE fluoroscopy pedal at time, and to configure the footswitch to the default Philips configuration. Customers were also instructed to review the information with all members of your staff who need to be aware; retain a copy with the equipment IFU and complete and return the Confirmation Respond form to Mail Stop 4302, 3000 Minuteman Road, Andover, MA 01810 or email: Debra.Gibbs@Philips.com. Philips is tracking the delivery of these notices via certified return receipt.
If you need any further information or support concerning this issue, please contact your local Philips representative: Technical Support Line: 1-800-722-9377.
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
Interventional fluoroscopic x-ray system - Product Code OWB
Causa
The use of allura xper, allura clarity, allura cv, allura centron and uniq systems regarding live images and still images can lead to still images being interpreted as live images.
Acción
The firm, Philips, issued "URGENT-Field Safety Notices" dated 10/26/2015 and 11/19/2015 to its customers. The notices described the product, problem and actions to be taken. The customers were instructed to ensure the audible signal (X-ray buzzer) is always enabled, to activate only ONE fluoroscopy pedal at time, and to configure the footswitch to the default Philips configuration. Customers were also instructed to review the information with all members of your staff who need to be aware; retain a copy with the equipment IFU and complete and return the Confirmation Respond form to Mail Stop 4302, 3000 Minuteman Road, Andover, MA 01810 or email: Debra.Gibbs@Philips.com. Philips is tracking the delivery of these notices via certified return receipt.
If you need any further information or support concerning this issue, please contact your local Philips representative: Technical Support Line: 1-800-722-9377.
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
Interventional fluoroscopic x-ray system - Product Code OWB
Causa
The use of allura xper, allura clarity, allura cv, allura centron and uniq systems regarding live images and still images can lead to still images being interpreted as live images.
Acción
The firm, Philips, issued "URGENT-Field Safety Notices" dated 10/26/2015 and 11/19/2015 to its customers. The notices described the product, problem and actions to be taken. The customers were instructed to ensure the audible signal (X-ray buzzer) is always enabled, to activate only ONE fluoroscopy pedal at time, and to configure the footswitch to the default Philips configuration. Customers were also instructed to review the information with all members of your staff who need to be aware; retain a copy with the equipment IFU and complete and return the Confirmation Respond form to Mail Stop 4302, 3000 Minuteman Road, Andover, MA 01810 or email: Debra.Gibbs@Philips.com. Philips is tracking the delivery of these notices via certified return receipt.
If you need any further information or support concerning this issue, please contact your local Philips representative: Technical Support Line: 1-800-722-9377.
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
Interventional fluoroscopic x-ray system - Product Code OWB
Causa
The use of allura xper, allura clarity, allura cv, allura centron and uniq systems regarding live images and still images can lead to still images being interpreted as live images.
Acción
The firm, Philips, issued "URGENT-Field Safety Notices" dated 10/26/2015 and 11/19/2015 to its customers. The notices described the product, problem and actions to be taken. The customers were instructed to ensure the audible signal (X-ray buzzer) is always enabled, to activate only ONE fluoroscopy pedal at time, and to configure the footswitch to the default Philips configuration. Customers were also instructed to review the information with all members of your staff who need to be aware; retain a copy with the equipment IFU and complete and return the Confirmation Respond form to Mail Stop 4302, 3000 Minuteman Road, Andover, MA 01810 or email: Debra.Gibbs@Philips.com. Philips is tracking the delivery of these notices via certified return receipt.
If you need any further information or support concerning this issue, please contact your local Philips representative: Technical Support Line: 1-800-722-9377.
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.
Large objects with fine resolution are potentially displayed cropped when imported into adaptive hybrid surgery analysis version 1.0.0.
Acción
Brainlab sent a FIELD SAFETY NOTICE / PRODUCT NOTIFICATION letter dated November 5, 2015, to all direct accounts informing the of the recall and actions to be taken.
User Corrective Action:
Users of Brain Metastases Version 1.0.0 or Adaptive Hybrid Surgery Analysis 1.0.0 shall adhere to the following:
After import always carefully review and verify all objects for correctness and validity.
For reviewing an object, select the image set which was used to outline or to modify the objects in the Data menu. Also compare the contours of an object in Brain Metastases or Adaptive Hybrid Surgery Analysis software to the contours in SmartBrush.
Please note that the error will not be visible in SmartBrush. Always verify the correct shape of the objects in Brain Metastases or Adaptive Hybrid Surgery Analysis software. If possible do not use image data sets with large slice distance and/or with a low amount of slices. To retrospectively identify if cropped objects have been used for treatment planning, the object contours of a specific treatment plan can be reviewed in Brainlab Dose Review, where the error will also be visible.
Brainlab will provide a software update with this issue solved to affected customers. Brainlab will actively contact affected customers tentatively starting February 2016 to schedule the update.
The request that users advise the appropriate personnel working in their department of the content of the Notification letter.
If the user facilities require further clarification, thay can contact their local Brainlab Customer Support Representative.
Customer Hotline: +49 89 99 15 68 44 or +1 800 597 5911 (for US customers)
E-mail: support@brainlab.com (for US customers: us.support@brainlab.com)
Fax: Brainlab AG: + 49 89 99 15 68 33
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
Interventional fluoroscopic x-ray system - Product Code OWB
Causa
The use of allura xper, allura clarity, allura cv, allura centron and uniq systems regarding live images and still images can lead to still images being interpreted as live images.
Acción
The firm, Philips, issued "URGENT-Field Safety Notices" dated 10/26/2015 and 11/19/2015 to its customers. The notices described the product, problem and actions to be taken. The customers were instructed to ensure the audible signal (X-ray buzzer) is always enabled, to activate only ONE fluoroscopy pedal at time, and to configure the footswitch to the default Philips configuration. Customers were also instructed to review the information with all members of your staff who need to be aware; retain a copy with the equipment IFU and complete and return the Confirmation Respond form to Mail Stop 4302, 3000 Minuteman Road, Andover, MA 01810 or email: Debra.Gibbs@Philips.com. Philips is tracking the delivery of these notices via certified return receipt.
If you need any further information or support concerning this issue, please contact your local Philips representative: Technical Support Line: 1-800-722-9377.
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
Laryngoscope, rigid - Product Code CCW
Causa
Certain models and serial numbers of glidescope gvl and avl laryngoscope blades may separate, due to inadequate bonding of the silicone adhesive affixing the halves of the blade. the potential for blade separation may not be readily visible during routine inspection before or after intubation.
Acción
The Urgent Medical Device Recall letter, dated November 30, 2015, had an error on the dates of manufacture for the AVL devices. Once Verathon discovered the incorrect information, the notification letter was revised and it was sent on December 7, 2015 to any customers that received the previous letter between 11/30/15 and 12/2/15.
****************************************************************************************
Verathon sent an Urgent Medical Device Recall letter dated November 30, 2015, to all affected consignees.
Verathon will, at no cost to you, test your GlideScope GVL and/or AVL blades that fall within the serial number ranges identified to determine whether the blades exhibit the defect that may result in separation of the blade.
For all blades that we determine to exhibit this defect, Verathon will replace the blade, free of charge, with a blade of the same model and size. If the blade passes the testing without any evidence of the defect, we will return it to you in its current condition.
Please note that this testing will not return blades to their original, factory condition. Verathon will provide you with a loaner blade for each blade in your possession that is subject to this recall, so you will not experience any interruption in use of your GlideScope system.
To comply with this recall notice for the affected models and serial numbers of GlideScope GVL and A VL blades, please take the following actions:
" Fill out the attached Recall Response Form and return it to Verathon by fax, (425) 883-2896, or email, CSNotifications@verathon.com . Please return the form even if you do not have any blades subject to the recall.
" Contact Customer Care to arrange for delivery of a loaner blade and return of your recalled blade. Customer Care will issue you an "RMA" number and arrange for shipment of a loaner blade. Do not send us your current blade(s) until you receive the loaner blade(s).
Should you have any questions about th
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
Laryngoscope, rigid - Product Code CCW
Causa
Certain models and serial numbers of glidescope gvl and avl laryngoscope blades may separate, due to inadequate bonding of the silicone adhesive affixing the halves of the blade. the potential for blade separation may not be readily visible during routine inspection before or after intubation.
Acción
The Urgent Medical Device Recall letter, dated November 30, 2015, had an error on the dates of manufacture for the AVL devices. Once Verathon discovered the incorrect information, the notification letter was revised and it was sent on December 7, 2015 to any customers that received the previous letter between 11/30/15 and 12/2/15.
****************************************************************************************
Verathon sent an Urgent Medical Device Recall letter dated November 30, 2015, to all affected consignees.
Verathon will, at no cost to you, test your GlideScope GVL and/or AVL blades that fall within the serial number ranges identified to determine whether the blades exhibit the defect that may result in separation of the blade.
For all blades that we determine to exhibit this defect, Verathon will replace the blade, free of charge, with a blade of the same model and size. If the blade passes the testing without any evidence of the defect, we will return it to you in its current condition.
Please note that this testing will not return blades to their original, factory condition. Verathon will provide you with a loaner blade for each blade in your possession that is subject to this recall, so you will not experience any interruption in use of your GlideScope system.
To comply with this recall notice for the affected models and serial numbers of GlideScope GVL and A VL blades, please take the following actions:
" Fill out the attached Recall Response Form and return it to Verathon by fax, (425) 883-2896, or email, CSNotifications@verathon.com . Please return the form even if you do not have any blades subject to the recall.
" Contact Customer Care to arrange for delivery of a loaner blade and return of your recalled blade. Customer Care will issue you an "RMA" number and arrange for shipment of a loaner blade. Do not send us your current blade(s) until you receive the loaner blade(s).
Should you have any questions about th
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
Calculator/data processing module, for clinical use - Product Code JQP
Causa
Myla¿ software connected to a laboratory information system (lis) and a vitek¿ 2 system has the potential to link a test result to an incorrect patient record with the same specimen id.
Acción
bioMerieux sent an Urgent Product Correction Notice letter dated November10, 2015 via FedEx to affected customers. The letter identified the affected product, problem and actions to be taken. For questions contact your local bioM¿rieux Clinical Customer Service organization at (800) 682-2666.
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
Calculator/data processing module, for clinical use - Product Code JQP
Causa
Myla¿ software connected to a laboratory information system (lis) and a vitek¿ 2 system has the potential to link a test result to an incorrect patient record with the same specimen id.
Acción
bioMerieux sent an Urgent Product Correction Notice letter dated November10, 2015 via FedEx to affected customers. The letter identified the affected product, problem and actions to be taken. For questions contact your local bioM¿rieux Clinical Customer Service organization at (800) 682-2666.
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
Calculator/data processing module, for clinical use - Product Code JQP
Causa
Myla¿ software connected to a laboratory information system (lis) and a vitek¿ 2 system has the potential to link a test result to an incorrect patient record with the same specimen id.
Acción
bioMerieux sent an Urgent Product Correction Notice letter dated November10, 2015 via FedEx to affected customers. The letter identified the affected product, problem and actions to be taken. For questions contact your local bioM¿rieux Clinical Customer Service organization at (800) 682-2666.
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
Introducer, Catheter - Product Code DYB
Causa
The tip of the stiffened cannula might break during use
and remain in the patient.
Acción
Recall letters were sent to each customer on November 26, 2002 advising them of the recall and to return stocks on hand.
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
Calculator/data processing module, for clinical use - Product Code JQP
Causa
Myla¿ software connected to a laboratory information system (lis) and a vitek¿ 2 system has the potential to link a test result to an incorrect patient record with the same specimen id.
Acción
bioMerieux sent an Urgent Product Correction Notice letter dated November10, 2015 via FedEx to affected customers. The letter identified the affected product, problem and actions to be taken. For questions contact your local bioM¿rieux Clinical Customer Service organization at (800) 682-2666.
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
Screwdriver, surgical - Product Code LRZ
Causa
The flexible shaft of the instruments may break during orthopedic spinal surgery. there is a risk of a delay in surgery or that a fragment from the shaft could be left in a patient.
Acción
The firm, Aesculap Implant Systems, sent a "URGENT MEDICAL DEVICE RECALL" letter dated Nov. 23, 2015 to all consignees via certified letter with return receipt. Distributors and sales reps will be notified via e-mail with return receipt. The letter described the product, problem and actions to be taken. The consignees were instructed to review the product recall notification in its entirety and ensure all users your organization and other concerned persons are informed; determine your current inventory; do not destroy any affected product; immediately remove and return the affected instruments-these instruments may be located within Set ST0485; use the U joint screwdriver, ME014R in place of the SJ706R of which is already part of set ST0485; If you require Customer Service assistance please call: Customer Service: 866-229-3002 or Email: SetWorld_Orders.BBMUS_Service@aesculap.com., and complete and return the Product Removal Acknowledgement Form to Aesculap Quality Assurance Department via mail to: Aesculap Inc., 615 Lambert Pointe Drive, Hazelwood, MO 63042; fax to: 610-791-6882 or email to: val.strawn@aesculap.com within two (2) weeks of receipt, even if the total inventory in your possession is zero (0).
A replacement for the SJ607R will be sent to you when one becomes available (ME190R).
If you have any questions, contact via email: val.strawn@aesculap.com/Tel: 610-984-9414 or email: Gordon.young@aesculap.com/Tel: 610-984-9043.
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
Gas-machine, anesthesia - Product Code BSZ
Causa
There is a potential problem with the device main power switch of the perseus a500 anesthesia workstation. the device power switch may spontaneously fail during use, causing one of the following to occur: 1. the workstation has a fresh gas delivery failure and a ventilator failure with respective alarms. 2. the workstation shuts down completely with an audible alarm.
Acción
Draeger Medical, Inc. sent Urgent Medical Device Recall Letters, dated November 2015, to consignees on November 10, 2015. The letter identified the affected device and the reason for the recall. The device power switch of the affected workstations must be replace. Customers should refer to the list of affected serial numbers provided. A Drager Service Representative will contact customers to schedule the replacement free of charge, as soon as new switches are available. Until the replacement takes place, the workstation may only be operated under continuous supervision. Increased attention is necessary to notice the potential failure case early. All affected users should be informed. Customers can contact Michael Kelhart at 1-800-543-5047, (press 1 at the prompt, then 2, then 32349), with questions pertaining to the letter. Contact Drager Service Technical Support at 1-800-543-5047 for questions regarding the operation or servicing of the Drager Perseus A500.
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.
Ameditechs drugs of abuse tests listed above have shown reduced reactivity for up to two (2) of the nineteen (19) benzodiazepine (bzo) compounds for which specificity information is provided in the product insert. the particular bzo compounds for which there may be reduced reactivity are clonazepam and chlordiazepoxide.
Acción
A Medical Device Labeling Correction letter was sent on 11/16/15 to distributors and end users to inform them that Ameditechs Drugs of Abuse Tests have shown reduced reactivity for up to two (2) of the nineteen (19) BZO compounds for which specificity information is provided in the product insert. The letter informs the customers that the particular BZO compounds for which there may be reduced reactivity are Clonazepam and Chlordiazepoxide. Customers with questions are instructed to contact Ameditech at (844) 616-4453 or email at amt.fieldaction@alere.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.
Ameditechs drugs of abuse tests listed above have shown reduced reactivity for up to two (2) of the nineteen (19) benzodiazepine (bzo) compounds for which specificity information is provided in the product insert. the particular bzo compounds for which there may be reduced reactivity are clonazepam and chlordiazepoxide.
Acción
A Medical Device Labeling Correction letter was sent on 11/16/15 to distributors and end users to inform them that Ameditechs Drugs of Abuse Tests have shown reduced reactivity for up to two (2) of the nineteen (19) BZO compounds for which specificity information is provided in the product insert. The letter informs the customers that the particular BZO compounds for which there may be reduced reactivity are Clonazepam and Chlordiazepoxide. Customers with questions are instructed to contact Ameditech at (844) 616-4453 or email at amt.fieldaction@alere.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.
Failure of the heater-cooler unit (hcu 30) type 2 power supply board. a drop of more than 10% voltage can cause overheating and subsequent failing of the r56 thermistor of the power supply board. board failure typically occurs when the compressor is switched on (prior to patient use); however, it can occur during patient use. this can shut down the compressor or the entire hcu 30 type 2 unit.
Acción
MAQUET sent "Product Recall Urgent Medical Device Field Correction" notices and "Medical Device Field Correction Response Forms" dated 11/13/2015 via UPS to affected customers. The notification identified the issue and how to identify the affected unit. The notification instructed customers to always keep a replacement heater-cooler unit on standby in the event of a unit failure; complete the attached Field Correction Response form (fax to 1.973.629.1518 or email to HCU30@maquet.com; and that they would be contacted by a representative of the Maquet Service Team to schedule an onsite service to determine if the power supply board in their HCU 30 Type 2 unit is affected adn replace the power supply board as necessary. If the customer had any questions they are instructed to contact their Maquet Service Representative or Maquet Technical Support at 1.888.627.8383 (Press option 3, followed by Option 1 and then option 1 again), Monday through Friday between the hours of 8:00 am and 5:00 pm.
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
Appliance, fixation, spinal intervertebral body - Product Code KWQ
Causa
Manufacturing error within the torque handle may prohibit some handles from being able to fully assemble with the tightener shaft. the design of the inspection gage does not account for the additional shift length.
Acción
DePuy sent an Urgent Voluntary Product Recall Notification dated November 17, 2015, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer.
They were asked to do the following: 1. Review inventory located within your facility and quarantine any products listed in this recall notice. Please contact your DePuy Synthes Spine* Sales Consultant to return any inventory located within your facility. 2. Review, complete, sign and return the attached business reply form to in accordance with the directions on the business reply form within 5 business days of receipt of this notification.
3. Forward this notice to anyone in your facility that needs to be informed.
4. If any product listed below has been forwarded to another facility, contact that facility and provide them with this letter. 5. Keep a copy of this notice.
For further questions please call (508) 828-3774
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
Tourniquet, pneumatic - Product Code KCY
Causa
Sterilmed, inc. is voluntarily recalling all unexpired reprocessed tourniquet cuffs. sterilmed cannot assure the sterility of all units in the recalled lots. the introduction of non-sterile product into a sterile operative field raises the risk of potential infection. sterilmed has not received any reports of adverse events for this issue.
Acción
Consignees were sent a Sterilmed "Urgent Medical Device Recall: letter dated November 13, 2015. The letter was addressed to Materials Manager, Risk Manager and Operating Room Director. The letter described the product affected, the description of the problem and the Actions Required. Requested consignees to quarantine and return affected product and to complete and return the
Business Reply Form. For questions contact Sterilmed's Customer Care Team at 888-541-0078.
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.
Images contained within radiographic transparency art 1036 are undersized.
Acción
BIOMET3i sent an" Urgent Medical Device Recall letter " dated November, 2015, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer.
Responsibilities:
1. Please review this notice and check your inventory for the affected item by comparing any on-hand ART 1036 Transparencies to a standard 8.5" x 11" sheet of paper. The non-conforming ART 1036 is approximately 7.8" x 10.2".
2. Immediately quarantine and remove all affected items from service.
3. Complete the attached Business Reply Form and either:
a. fax it to 561-514-6316 or
b. email it to postmarket@biomet.com or
c. return it along with the affected product using the included shipping label
4. Return affected product to BIOMET 3i.
For assistance or other questions that you may have relative to this notice, please contact BIOMET 3i at 1- 800-342-5454 or 1-561-776-6700. Team members are available to assist you 8:00am to 6:00pm (Eastern), Monday through Friday.
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.
Ameditechs drugs of abuse tests listed above have shown reduced reactivity for up to two (2) of the nineteen (19) benzodiazepine (bzo) compounds for which specificity information is provided in the product insert. the particular bzo compounds for which there may be reduced reactivity are clonazepam and chlordiazepoxide.
Acción
A Medical Device Labeling Correction letter was sent on 11/16/15 to distributors and end users to inform them that Ameditechs Drugs of Abuse Tests have shown reduced reactivity for up to two (2) of the nineteen (19) BZO compounds for which specificity information is provided in the product insert. The letter informs the customers that the particular BZO compounds for which there may be reduced reactivity are Clonazepam and Chlordiazepoxide. Customers with questions are instructed to contact Ameditech at (844) 616-4453 or email at amt.fieldaction@alere.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
Set, tubing, blood, with and without anti-regurgitation valve - Product Code FJK
Causa
Blood foaming was found during evaluation of the product.
Acción
NIPRO contacted their consignees by email 9/25/2013 of the affected product. Customers were instructed to return product back to Nipro Medical Warehouse or discard at point of use.
Please contact Director of QA/RA at Nipro Medical Corporation for any additional information or return correspondence to JessicaO@nipromed.com / 305.599.7174x249.
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.
Ameditechs drugs of abuse tests listed above have shown reduced reactivity for up to two (2) of the nineteen (19) benzodiazepine (bzo) compounds for which specificity information is provided in the product insert. the particular bzo compounds for which there may be reduced reactivity are clonazepam and chlordiazepoxide.
Acción
A Medical Device Labeling Correction letter was sent on 11/16/15 to distributors and end users to inform them that Ameditechs Drugs of Abuse Tests have shown reduced reactivity for up to two (2) of the nineteen (19) BZO compounds for which specificity information is provided in the product insert. The letter informs the customers that the particular BZO compounds for which there may be reduced reactivity are Clonazepam and Chlordiazepoxide. Customers with questions are instructed to contact Ameditech at (844) 616-4453 or email at amt.fieldaction@alere.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.
Ameditechs drugs of abuse tests listed above have shown reduced reactivity for up to two (2) of the nineteen (19) benzodiazepine (bzo) compounds for which specificity information is provided in the product insert. the particular bzo compounds for which there may be reduced reactivity are clonazepam and chlordiazepoxide.
Acción
A Medical Device Labeling Correction letter was sent on 11/16/15 to distributors and end users to inform them that Ameditechs Drugs of Abuse Tests have shown reduced reactivity for up to two (2) of the nineteen (19) BZO compounds for which specificity information is provided in the product insert. The letter informs the customers that the particular BZO compounds for which there may be reduced reactivity are Clonazepam and Chlordiazepoxide. Customers with questions are instructed to contact Ameditech at (844) 616-4453 or email at amt.fieldaction@alere.com.