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.
Heat exchanger may contain loose particulate matter.
Acción
Terumo Cardiovascular Systems notified customers by telephone on 11/8/02 by telephone, fax, and mail to advise distributors and end-users to cease use of the Heat Coil.. A follow-up letter issued to the accounts with instructions for the return of product.
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
Pin, fixation, smooth - Product Code HTY
Causa
The firm is recalling various trauma guide wires due to insufficient packaging design verification and exceeding the expected occurrence rate of complaints for sterile barrier failure. guide wires packaged in the affected packaging configuration have the potential for sterile barrier breach, leading to possible risk for infection.
Acción
The firm, Zimmer Biomet, sent an "URGENT MEDICAL DEVICE RECALL" letter dated May 16, 2018 on May 16, 2018, to affected consignees via email and FedEx. The letter describes the product, problem and actions to be taken. Consignees were informed of the recall and instructed to take the following actions:
Risk Manager Responsibilities:
1. Review this notification and ensure that affected personnel are aware of the contents.
2. If you have affected product at your facility, assist your Zimmer Biomet sales representative and quarantine all affected product. Your Zimmer Biomet sales representative will remove the affected product from your facility.
3. Complete Attachment 1 Certificate of Acknowledgement and send to CorporateQuality.PostMarket@zimmerbiomet.com. This form must be returned even if you do not have affected products at your facility.
Distributor Responsibilities:
1. Review this notification and ensure that affected team members are aware of the contents.
2. Immediately locate and quarantine affected product in your inventory.
3. Immediately return all affected product from your distributorship and from affected hospitals within your territory.
a. For each return, send a copy of Attachment 1 to CorporateQuality.PostMarket@zimmerbiomet.com
b. International returns, please request an IRA by emailing zimmerbiometintlirarequests@zimmerbiomet.com
c. Include a hardcopy of Attachment 1 in each carton of your return shipment for immediate processing.
d. Mark RECALL on the outside of the returned cartons.
4. Return the Additional Accounts form to CorporateQuality.PostMarket@zimmerbiomet.com.
a. Review the list of hospitals included with the email notification sent to your facility, which includes a list of hospitals that have already been notified of this recall.
b. Identify whether there are any additional hospitals that Zimmer Biomet has not notified and list these accounts on the Additional Accounts form. Please provide the form in Excel format
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
Clamp - Product Code HXD
Causa
Laser etching which indicates whether the device is in
compression or distraction mode appears to be on the wrong side of the lever arm.
Acción
On May 8, 2018, URGENT PRODUCT RECALL and BUSINESS REPLY notices were issued to U.S.A customers via UPS. Customers are encouraged to take the following actions:
1. Inform individuals within your organization who need to be aware of this device recall.
2. Immediately check all stock areas and/or operating room storage to determine if any devices from the affected product list are at your facility. Response is required by submitted the completed response form via email to: StrykerOrtho6487@stericycle.com, even though you may not have any physical inventory on site anymore.
3. Quarantine and discontinue use of the recalled devices.
4. Maintain awareness of this notice internally until all required actions have been completed within your facility
5. Inform Stryker if any of the subject devices have been distributed to other organizations.
a) Please provide contact details so that Stryker can inform the recipients appropriately.
b) If you are a Distributor, note that you are responsible for notifying your affected customers.
Customers with questions may call 201-831-5000.
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
Heart valve, more than minimally manipulated allograft - Product Code OHA
Causa
Devices, which met fda and aatb eligibility criteria, were distributed. final autopsy and toxicology reports indicated the presence of morphine in the urine.
Acción
The firm notified the consignees by letter on 05/14/2018.
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.
Devices, which met fda and aatb eligibility criteria, were distributed. final autopsy and toxicology reports indicated the presence of morphine in the urine.
Acción
The firm notified the consignees by letter on 05/14/2018.
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
Siemens medical solutions usa, inc., molecular imaging business line became aware, through our supplier that some laser cover windows may fall off a limited population of the biograph mct and biograph mct flow systems.
Acción
The firm notified the consignees of the issue by email on May 29, 2018. The letter identified the affected product, problem and actions to be taken. They are tracking completion of the letter delivery through the hand-delivered approach.
For further questions, please call (847) 304-7700.
.
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.
There is a potential for the patient port retaining ring to not fully seat allowing the patient port to detach during use. this may impact air delivery to the patient.
Acción
On May 25, 2018 Sun Med, LLC issued URGENT MEDICAL DEVICE PRODUCT REMOVAL notices to two of their customers. On June 1, 2018 Sun Med, LLC issued a press release. Customers were encouraged to take the following actions:
1) Examine inventory, quarantine and cease distribution of impacted product.
2) If customers further distributed product, please identify your customers/consignees and notify them of this product removal. Your notification may be enhanced by including a copy of the removal notice. If you need any assistance contacting your customers, please inform SunMed.
3) Complete and return the Removal Return Response Form via fax to 1-800-400-8820 or via email to info@sun-med.com as soon as possible.
4) Once you return the affected product(s), new corrected replacement resuscitation bags will be provided to you. If you need replacement products to be sent to you urgently, please call SunMed directly.
Customers with questions can call 1-800-433-2797 or email info@sun-med.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.
There is a potential for the patient port retaining ring to not fully seat allowing the patient port to detach during use. this may impact air delivery to the patient.
Acción
On May 25, 2018 Sun Med, LLC issued URGENT MEDICAL DEVICE PRODUCT REMOVAL notices to two of their customers. On June 1, 2018 Sun Med, LLC issued a press release. Customers were encouraged to take the following actions:
1) Examine inventory, quarantine and cease distribution of impacted product.
2) If customers further distributed product, please identify your customers/consignees and notify them of this product removal. Your notification may be enhanced by including a copy of the removal notice. If you need any assistance contacting your customers, please inform SunMed.
3) Complete and return the Removal Return Response Form via fax to 1-800-400-8820 or via email to info@sun-med.com as soon as possible.
4) Once you return the affected product(s), new corrected replacement resuscitation bags will be provided to you. If you need replacement products to be sent to you urgently, please call SunMed directly.
Customers with questions can call 1-800-433-2797 or email info@sun-med.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.
There is a potential for the patient port retaining ring to not fully seat allowing the patient port to detach during use. this may impact air delivery to the patient.
Acción
On May 25, 2018 Sun Med, LLC issued URGENT MEDICAL DEVICE PRODUCT REMOVAL notices to two of their customers. On June 1, 2018 Sun Med, LLC issued a press release. Customers were encouraged to take the following actions:
1) Examine inventory, quarantine and cease distribution of impacted product.
2) If customers further distributed product, please identify your customers/consignees and notify them of this product removal. Your notification may be enhanced by including a copy of the removal notice. If you need any assistance contacting your customers, please inform SunMed.
3) Complete and return the Removal Return Response Form via fax to 1-800-400-8820 or via email to info@sun-med.com as soon as possible.
4) Once you return the affected product(s), new corrected replacement resuscitation bags will be provided to you. If you need replacement products to be sent to you urgently, please call SunMed directly.
Customers with questions can call 1-800-433-2797 or email info@sun-med.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.
There is a potential for the patient port retaining ring to not fully seat allowing the patient port to detach during use. this may impact air delivery to the patient.
Acción
On May 25, 2018 Sun Med, LLC issued URGENT MEDICAL DEVICE PRODUCT REMOVAL notices to two of their customers. On June 1, 2018 Sun Med, LLC issued a press release. Customers were encouraged to take the following actions:
1) Examine inventory, quarantine and cease distribution of impacted product.
2) If customers further distributed product, please identify your customers/consignees and notify them of this product removal. Your notification may be enhanced by including a copy of the removal notice. If you need any assistance contacting your customers, please inform SunMed.
3) Complete and return the Removal Return Response Form via fax to 1-800-400-8820 or via email to info@sun-med.com as soon as possible.
4) Once you return the affected product(s), new corrected replacement resuscitation bags will be provided to you. If you need replacement products to be sent to you urgently, please call SunMed directly.
Customers with questions can call 1-800-433-2797 or email info@sun-med.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.
There is a potential for the patient port retaining ring to not fully seat allowing the patient port to detach during use. this may impact air delivery to the patient.
Acción
On May 25, 2018 Sun Med, LLC issued URGENT MEDICAL DEVICE PRODUCT REMOVAL notices to two of their customers. On June 1, 2018 Sun Med, LLC issued a press release. Customers were encouraged to take the following actions:
1) Examine inventory, quarantine and cease distribution of impacted product.
2) If customers further distributed product, please identify your customers/consignees and notify them of this product removal. Your notification may be enhanced by including a copy of the removal notice. If you need any assistance contacting your customers, please inform SunMed.
3) Complete and return the Removal Return Response Form via fax to 1-800-400-8820 or via email to info@sun-med.com as soon as possible.
4) Once you return the affected product(s), new corrected replacement resuscitation bags will be provided to you. If you need replacement products to be sent to you urgently, please call SunMed directly.
Customers with questions can call 1-800-433-2797 or email info@sun-med.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.
There is a potential for the patient port retaining ring to not fully seat allowing the patient port to detach during use. this may impact air delivery to the patient.
Acción
On May 25, 2018 Sun Med, LLC issued URGENT MEDICAL DEVICE PRODUCT REMOVAL notices to two of their customers. On June 1, 2018 Sun Med, LLC issued a press release. Customers were encouraged to take the following actions:
1) Examine inventory, quarantine and cease distribution of impacted product.
2) If customers further distributed product, please identify your customers/consignees and notify them of this product removal. Your notification may be enhanced by including a copy of the removal notice. If you need any assistance contacting your customers, please inform SunMed.
3) Complete and return the Removal Return Response Form via fax to 1-800-400-8820 or via email to info@sun-med.com as soon as possible.
4) Once you return the affected product(s), new corrected replacement resuscitation bags will be provided to you. If you need replacement products to be sent to you urgently, please call SunMed directly.
Customers with questions can call 1-800-433-2797 or email info@sun-med.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.
There is a potential for the patient port retaining ring to not fully seat allowing the patient port to detach during use. this may impact air delivery to the patient.
Acción
On May 25, 2018 Sun Med, LLC issued URGENT MEDICAL DEVICE PRODUCT REMOVAL notices to two of their customers. On June 1, 2018 Sun Med, LLC issued a press release. Customers were encouraged to take the following actions:
1) Examine inventory, quarantine and cease distribution of impacted product.
2) If customers further distributed product, please identify your customers/consignees and notify them of this product removal. Your notification may be enhanced by including a copy of the removal notice. If you need any assistance contacting your customers, please inform SunMed.
3) Complete and return the Removal Return Response Form via fax to 1-800-400-8820 or via email to info@sun-med.com as soon as possible.
4) Once you return the affected product(s), new corrected replacement resuscitation bags will be provided to you. If you need replacement products to be sent to you urgently, please call SunMed directly.
Customers with questions can call 1-800-433-2797 or email info@sun-med.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.
There is a potential for the patient port retaining ring to not fully seat allowing the patient port to detach during use. this may impact air delivery to the patient.
Acción
On May 25, 2018 Sun Med, LLC issued URGENT MEDICAL DEVICE PRODUCT REMOVAL notices to two of their customers. On June 1, 2018 Sun Med, LLC issued a press release. Customers were encouraged to take the following actions:
1) Examine inventory, quarantine and cease distribution of impacted product.
2) If customers further distributed product, please identify your customers/consignees and notify them of this product removal. Your notification may be enhanced by including a copy of the removal notice. If you need any assistance contacting your customers, please inform SunMed.
3) Complete and return the Removal Return Response Form via fax to 1-800-400-8820 or via email to info@sun-med.com as soon as possible.
4) Once you return the affected product(s), new corrected replacement resuscitation bags will be provided to you. If you need replacement products to be sent to you urgently, please call SunMed directly.
Customers with questions can call 1-800-433-2797 or email info@sun-med.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.
There is a potential for the patient port retaining ring to not fully seat allowing the patient port to detach during use. this may impact air delivery to the patient.
Acción
On May 25, 2018 Sun Med, LLC issued URGENT MEDICAL DEVICE PRODUCT REMOVAL notices to two of their customers. On June 1, 2018 Sun Med, LLC issued a press release. Customers were encouraged to take the following actions:
1) Examine inventory, quarantine and cease distribution of impacted product.
2) If customers further distributed product, please identify your customers/consignees and notify them of this product removal. Your notification may be enhanced by including a copy of the removal notice. If you need any assistance contacting your customers, please inform SunMed.
3) Complete and return the Removal Return Response Form via fax to 1-800-400-8820 or via email to info@sun-med.com as soon as possible.
4) Once you return the affected product(s), new corrected replacement resuscitation bags will be provided to you. If you need replacement products to be sent to you urgently, please call SunMed directly.
Customers with questions can call 1-800-433-2797 or email info@sun-med.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.
There is a potential for the patient port retaining ring to not fully seat allowing the patient port to detach during use. this may impact air delivery to the patient.
Acción
On May 25, 2018 Sun Med, LLC issued URGENT MEDICAL DEVICE PRODUCT REMOVAL notices to two of their customers. On June 1, 2018 Sun Med, LLC issued a press release. Customers were encouraged to take the following actions:
1) Examine inventory, quarantine and cease distribution of impacted product.
2) If customers further distributed product, please identify your customers/consignees and notify them of this product removal. Your notification may be enhanced by including a copy of the removal notice. If you need any assistance contacting your customers, please inform SunMed.
3) Complete and return the Removal Return Response Form via fax to 1-800-400-8820 or via email to info@sun-med.com as soon as possible.
4) Once you return the affected product(s), new corrected replacement resuscitation bags will be provided to you. If you need replacement products to be sent to you urgently, please call SunMed directly.
Customers with questions can call 1-800-433-2797 or email info@sun-med.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.
There is a potential for the patient port retaining ring to not fully seat allowing the patient port to detach during use. this may impact air delivery to the patient.
Acción
On May 25, 2018 Sun Med, LLC issued URGENT MEDICAL DEVICE PRODUCT REMOVAL notices to two of their customers. On June 1, 2018 Sun Med, LLC issued a press release. Customers were encouraged to take the following actions:
1) Examine inventory, quarantine and cease distribution of impacted product.
2) If customers further distributed product, please identify your customers/consignees and notify them of this product removal. Your notification may be enhanced by including a copy of the removal notice. If you need any assistance contacting your customers, please inform SunMed.
3) Complete and return the Removal Return Response Form via fax to 1-800-400-8820 or via email to info@sun-med.com as soon as possible.
4) Once you return the affected product(s), new corrected replacement resuscitation bags will be provided to you. If you need replacement products to be sent to you urgently, please call SunMed directly.
Customers with questions can call 1-800-433-2797 or email info@sun-med.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.
There is a potential for the patient port retaining ring to not fully seat allowing the patient port to detach during use. this may impact air delivery to the patient.
Acción
On May 25, 2018 Sun Med, LLC issued URGENT MEDICAL DEVICE PRODUCT REMOVAL notices to two of their customers. On June 1, 2018 Sun Med, LLC issued a press release. Customers were encouraged to take the following actions:
1) Examine inventory, quarantine and cease distribution of impacted product.
2) If customers further distributed product, please identify your customers/consignees and notify them of this product removal. Your notification may be enhanced by including a copy of the removal notice. If you need any assistance contacting your customers, please inform SunMed.
3) Complete and return the Removal Return Response Form via fax to 1-800-400-8820 or via email to info@sun-med.com as soon as possible.
4) Once you return the affected product(s), new corrected replacement resuscitation bags will be provided to you. If you need replacement products to be sent to you urgently, please call SunMed directly.
Customers with questions can call 1-800-433-2797 or email info@sun-med.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.
There is a potential for the patient port retaining ring to not fully seat allowing the patient port to detach during use. this may impact air delivery to the patient.
Acción
On May 25, 2018 Sun Med, LLC issued URGENT MEDICAL DEVICE PRODUCT REMOVAL notices to two of their customers. On June 1, 2018 Sun Med, LLC issued a press release. Customers were encouraged to take the following actions:
1) Examine inventory, quarantine and cease distribution of impacted product.
2) If customers further distributed product, please identify your customers/consignees and notify them of this product removal. Your notification may be enhanced by including a copy of the removal notice. If you need any assistance contacting your customers, please inform SunMed.
3) Complete and return the Removal Return Response Form via fax to 1-800-400-8820 or via email to info@sun-med.com as soon as possible.
4) Once you return the affected product(s), new corrected replacement resuscitation bags will be provided to you. If you need replacement products to be sent to you urgently, please call SunMed directly.
Customers with questions can call 1-800-433-2797 or email info@sun-med.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.
There is a potential for the patient port retaining ring to not fully seat allowing the patient port to detach during use. this may impact air delivery to the patient.
Acción
On May 25, 2018 Sun Med, LLC issued URGENT MEDICAL DEVICE PRODUCT REMOVAL notices to two of their customers. On June 1, 2018 Sun Med, LLC issued a press release. Customers were encouraged to take the following actions:
1) Examine inventory, quarantine and cease distribution of impacted product.
2) If customers further distributed product, please identify your customers/consignees and notify them of this product removal. Your notification may be enhanced by including a copy of the removal notice. If you need any assistance contacting your customers, please inform SunMed.
3) Complete and return the Removal Return Response Form via fax to 1-800-400-8820 or via email to info@sun-med.com as soon as possible.
4) Once you return the affected product(s), new corrected replacement resuscitation bags will be provided to you. If you need replacement products to be sent to you urgently, please call SunMed directly.
Customers with questions can call 1-800-433-2797 or email info@sun-med.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
Gas-machine, anesthesia - Product Code BSZ
Causa
The draeger anesthesia device may be able to dose 100% n2o. in the event of a fault, the s-orc module would not prevent setting an n2o flow that would result
in a hypoxic mixture from being dosed to the patient. potential adverse outcomes include death of the patient.
Acción
On May 24, 2018, the firm issued Urgent Medical Device Recall letters to affected end users (medical facilities) via certified mail. The letter identified the affected product, problem and actions to be taken. The recalling firm stated that they are currently manufacturing replacement parts for all potentially affected devices, which will be installed as part of the next service. The firm's Service dept. will contact end users to arrange the replacement Free of Charge
In addition, end users were asked to complete and return a Customer Reply Card to acknowledge the receipt of this information.
If you have any questions regarding this recall please contact Michael Kelhart between the hours of 8:00 AM 4:30 PM EST at 1-800-437-2437 (press 1 at the prompt, then 32349). For questions regarding the operation and/or servicing of your Draeger anesthesia machine please contact DraegerService Technical Support between the hours of 8:00 AM 8:00 PM EST at 1-800-437-2437 (press 4 at the prompt then 4 again).
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
The draeger anesthesia device may be able to dose 100% n2o. in the event of a fault, the s-orc module would not prevent setting an n2o flow that would result
in a hypoxic mixture from being dosed to the patient. potential adverse outcomes include death of the patient.
Acción
On May 24, 2018, the firm issued Urgent Medical Device Recall letters to affected end users (medical facilities) via certified mail. The letter identified the affected product, problem and actions to be taken. The recalling firm stated that they are currently manufacturing replacement parts for all potentially affected devices, which will be installed as part of the next service. The firm's Service dept. will contact end users to arrange the replacement Free of Charge
In addition, end users were asked to complete and return a Customer Reply Card to acknowledge the receipt of this information.
If you have any questions regarding this recall please contact Michael Kelhart between the hours of 8:00 AM 4:30 PM EST at 1-800-437-2437 (press 1 at the prompt, then 32349). For questions regarding the operation and/or servicing of your Draeger anesthesia machine please contact DraegerService Technical Support between the hours of 8:00 AM 8:00 PM EST at 1-800-437-2437 (press 4 at the prompt then 4 again).
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
The draeger anesthesia device may be able to dose 100% n2o. in the event of a fault, the s-orc module would not prevent setting an n2o flow that would result
in a hypoxic mixture from being dosed to the patient. potential adverse outcomes include death of the patient.
Acción
On May 24, 2018, the firm issued Urgent Medical Device Recall letters to affected end users (medical facilities) via certified mail. The letter identified the affected product, problem and actions to be taken. The recalling firm stated that they are currently manufacturing replacement parts for all potentially affected devices, which will be installed as part of the next service. The firm's Service dept. will contact end users to arrange the replacement Free of Charge
In addition, end users were asked to complete and return a Customer Reply Card to acknowledge the receipt of this information.
If you have any questions regarding this recall please contact Michael Kelhart between the hours of 8:00 AM 4:30 PM EST at 1-800-437-2437 (press 1 at the prompt, then 32349). For questions regarding the operation and/or servicing of your Draeger anesthesia machine please contact DraegerService Technical Support between the hours of 8:00 AM 8:00 PM EST at 1-800-437-2437 (press 4 at the prompt then 4 again).
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
The draeger anesthesia device may be able to dose 100% n2o. in the event of a fault, the s-orc module would not prevent setting an n2o flow that would result
in a hypoxic mixture from being dosed to the patient. potential adverse outcomes include death of the patient.
Acción
On May 24, 2018, the firm issued Urgent Medical Device Recall letters to affected end users (medical facilities) via certified mail. The letter identified the affected product, problem and actions to be taken. The recalling firm stated that they are currently manufacturing replacement parts for all potentially affected devices, which will be installed as part of the next service. The firm's Service dept. will contact end users to arrange the replacement Free of Charge
In addition, end users were asked to complete and return a Customer Reply Card to acknowledge the receipt of this information.
If you have any questions regarding this recall please contact Michael Kelhart between the hours of 8:00 AM 4:30 PM EST at 1-800-437-2437 (press 1 at the prompt, then 32349). For questions regarding the operation and/or servicing of your Draeger anesthesia machine please contact DraegerService Technical Support between the hours of 8:00 AM 8:00 PM EST at 1-800-437-2437 (press 4 at the prompt then 4 again).
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
The draeger anesthesia device may be able to dose 100% n2o. in the event of a fault, the s-orc module would not prevent setting an n2o flow that would result
in a hypoxic mixture from being dosed to the patient. potential adverse outcomes include death of the patient.
Acción
On May 24, 2018, the firm issued Urgent Medical Device Recall letters to affected end users (medical facilities) via certified mail. The letter identified the affected product, problem and actions to be taken. The recalling firm stated that they are currently manufacturing replacement parts for all potentially affected devices, which will be installed as part of the next service. The firm's Service dept. will contact end users to arrange the replacement Free of Charge
In addition, end users were asked to complete and return a Customer Reply Card to acknowledge the receipt of this information.
If you have any questions regarding this recall please contact Michael Kelhart between the hours of 8:00 AM 4:30 PM EST at 1-800-437-2437 (press 1 at the prompt, then 32349). For questions regarding the operation and/or servicing of your Draeger anesthesia machine please contact DraegerService Technical Support between the hours of 8:00 AM 8:00 PM EST at 1-800-437-2437 (press 4 at the prompt then 4 again).