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.
Catheters may not meet antimicrobial specification.
Acción
Medtronic (Covidien) issued recalll letter dated April 24, 2015, via FedEx overnight delivery to all affected customers. Customers were requested to quarantine and discontinue use of the affected devices. Customers were instructed to complete A Recalled Product Return Form for product returns. Customer Service will respond with a Return Goods Authorization (RGA) number and shipping documents
Customers with questions were instructed to contact their Medtronic representative or Medtronic Customer Service, Monday through Friday, 8am 6:30pm ET, at (800)-882-5878.
For questions regarding this recall call 203-492-5000.
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.
Catheters may not meet antimicrobial specification.
Acción
Medtronic (Covidien) issued recalll letter dated April 24, 2015, via FedEx overnight delivery to all affected customers. Customers were requested to quarantine and discontinue use of the affected devices. Customers were instructed to complete A Recalled Product Return Form for product returns. Customer Service will respond with a Return Goods Authorization (RGA) number and shipping documents
Customers with questions were instructed to contact their Medtronic representative or Medtronic Customer Service, Monday through Friday, 8am 6:30pm ET, at (800)-882-5878.
For questions regarding this recall call 203-492-5000.
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.
Catheters may not meet antimicrobial specification.
Acción
Medtronic (Covidien) issued recalll letter dated April 24, 2015, via FedEx overnight delivery to all affected customers. Customers were requested to quarantine and discontinue use of the affected devices. Customers were instructed to complete A Recalled Product Return Form for product returns. Customer Service will respond with a Return Goods Authorization (RGA) number and shipping documents
Customers with questions were instructed to contact their Medtronic representative or Medtronic Customer Service, Monday through Friday, 8am 6:30pm ET, at (800)-882-5878.
For questions regarding this recall call 203-492-5000.
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.
Catheters may not meet antimicrobial specification.
Acción
Medtronic (Covidien) issued recalll letter dated April 24, 2015, via FedEx overnight delivery to all affected customers. Customers were requested to quarantine and discontinue use of the affected devices. Customers were instructed to complete A Recalled Product Return Form for product returns. Customer Service will respond with a Return Goods Authorization (RGA) number and shipping documents
Customers with questions were instructed to contact their Medtronic representative or Medtronic Customer Service, Monday through Friday, 8am 6:30pm ET, at (800)-882-5878.
For questions regarding this recall call 203-492-5000.
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.
Catheters may not meet antimicrobial specification.
Acción
Medtronic (Covidien) issued recalll letter dated April 24, 2015, via FedEx overnight delivery to all affected customers. Customers were requested to quarantine and discontinue use of the affected devices. Customers were instructed to complete A Recalled Product Return Form for product returns. Customer Service will respond with a Return Goods Authorization (RGA) number and shipping documents
Customers with questions were instructed to contact their Medtronic representative or Medtronic Customer Service, Monday through Friday, 8am 6:30pm ET, at (800)-882-5878.
For questions regarding this recall call 203-492-5000.
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.
Devon light gloves contain splits or holes compromising the sterility.
Acción
Medtronic/Covidien initiated recall on April 16, 2015 via FedEx and certified mail
Customers were instructed to discontinue use of the product and return all inventory and kits to Medtronic (Covidien) -Attention: Devon" Light Glove 110 Kendall Park Lane. Atlanta, GA 30336.
If you have any questions contact your Medtronic representative or Medtronic Customer Service, Monday through Friday, 8am to 6:30pm ET,
at (800) 882-5878.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Catheters may not meet antimicrobial specification.
Acción
Medtronic (Covidien) issued recalll letter dated April 24, 2015, via FedEx overnight delivery to all affected customers. Customers were requested to quarantine and discontinue use of the affected devices. Customers were instructed to complete A Recalled Product Return Form for product returns. Customer Service will respond with a Return Goods Authorization (RGA) number and shipping documents
Customers with questions were instructed to contact their Medtronic representative or Medtronic Customer Service, Monday through Friday, 8am 6:30pm ET, at (800)-882-5878.
For questions regarding this recall call 203-492-5000.
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.
Catheters may not meet antimicrobial specification.
Acción
Medtronic (Covidien) issued recalll letter dated April 24, 2015, via FedEx overnight delivery to all affected customers. Customers were requested to quarantine and discontinue use of the affected devices. Customers were instructed to complete A Recalled Product Return Form for product returns. Customer Service will respond with a Return Goods Authorization (RGA) number and shipping documents
Customers with questions were instructed to contact their Medtronic representative or Medtronic Customer Service, Monday through Friday, 8am 6:30pm ET, at (800)-882-5878.
For questions regarding this recall call 203-492-5000.
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.
Catheters may not meet antimicrobial specification.
Acción
Medtronic (Covidien) issued recalll letter dated April 24, 2015, via FedEx overnight delivery to all affected customers. Customers were requested to quarantine and discontinue use of the affected devices. Customers were instructed to complete A Recalled Product Return Form for product returns. Customer Service will respond with a Return Goods Authorization (RGA) number and shipping documents
Customers with questions were instructed to contact their Medtronic representative or Medtronic Customer Service, Monday through Friday, 8am 6:30pm ET, at (800)-882-5878.
For questions regarding this recall call 203-492-5000.
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.
Catheters may not meet antimicrobial specification.
Acción
Medtronic (Covidien) issued recalll letter dated April 24, 2015, via FedEx overnight delivery to all affected customers. Customers were requested to quarantine and discontinue use of the affected devices. Customers were instructed to complete A Recalled Product Return Form for product returns. Customer Service will respond with a Return Goods Authorization (RGA) number and shipping documents
Customers with questions were instructed to contact their Medtronic representative or Medtronic Customer Service, Monday through Friday, 8am 6:30pm ET, at (800)-882-5878.
For questions regarding this recall call 203-492-5000.
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.
Catheters may not meet antimicrobial specification.
Acción
Medtronic (Covidien) issued recalll letter dated April 24, 2015, via FedEx overnight delivery to all affected customers. Customers were requested to quarantine and discontinue use of the affected devices. Customers were instructed to complete A Recalled Product Return Form for product returns. Customer Service will respond with a Return Goods Authorization (RGA) number and shipping documents
Customers with questions were instructed to contact their Medtronic representative or Medtronic Customer Service, Monday through Friday, 8am 6:30pm ET, at (800)-882-5878.
For questions regarding this recall call 203-492-5000.
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
Saline, vascular access flush - Product Code NGT
Causa
Sterility may be compromised.
Acción
Medtronic/Covidien sent an Urgent Medical Device Recall letter August 7, 2015 to affected customers via Federal Express. The letter identified the affected product, problem and actions to be taken. The letter instructs customers to quarantine, discontinue use and return the affected product as instructed in the letter. For questions contact your Medtronic representative or Customer Service at (800)-882-5878
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Catheters may not meet antimicrobial specification.
Acción
Medtronic (Covidien) issued recalll letter dated April 24, 2015, via FedEx overnight delivery to all affected customers. Customers were requested to quarantine and discontinue use of the affected devices. Customers were instructed to complete A Recalled Product Return Form for product returns. Customer Service will respond with a Return Goods Authorization (RGA) number and shipping documents
Customers with questions were instructed to contact their Medtronic representative or Medtronic Customer Service, Monday through Friday, 8am 6:30pm ET, at (800)-882-5878.
For questions regarding this recall call 203-492-5000.
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.
Catheters may not meet antimicrobial specification.
Acción
Medtronic (Covidien) issued recalll letter dated April 24, 2015, via FedEx overnight delivery to all affected customers. Customers were requested to quarantine and discontinue use of the affected devices. Customers were instructed to complete A Recalled Product Return Form for product returns. Customer Service will respond with a Return Goods Authorization (RGA) number and shipping documents
Customers with questions were instructed to contact their Medtronic representative or Medtronic Customer Service, Monday through Friday, 8am 6:30pm ET, at (800)-882-5878.
For questions regarding this recall call 203-492-5000.
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.
Catheters may not meet antimicrobial specification.
Acción
Medtronic (Covidien) issued recalll letter dated April 24, 2015, via FedEx overnight delivery to all affected customers. Customers were requested to quarantine and discontinue use of the affected devices. Customers were instructed to complete A Recalled Product Return Form for product returns. Customer Service will respond with a Return Goods Authorization (RGA) number and shipping documents
Customers with questions were instructed to contact their Medtronic representative or Medtronic Customer Service, Monday through Friday, 8am 6:30pm ET, at (800)-882-5878.
For questions regarding this recall call 203-492-5000.
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.
Catheters may not meet antimicrobial specification.
Acción
Medtronic (Covidien) issued recalll letter dated April 24, 2015, via FedEx overnight delivery to all affected customers. Customers were requested to quarantine and discontinue use of the affected devices. Customers were instructed to complete A Recalled Product Return Form for product returns. Customer Service will respond with a Return Goods Authorization (RGA) number and shipping documents
Customers with questions were instructed to contact their Medtronic representative or Medtronic Customer Service, Monday through Friday, 8am 6:30pm ET, at (800)-882-5878.
For questions regarding this recall call 203-492-5000.
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
Detector and alarm, arrhythmia - Product Code DSI
Causa
Ultraview sl command modules which were upgraded with the masimo spo2 option, model 91496-m was affected. customer reported that during the time that the module is resetting (~10 seconds), monitoring of all parameters will be suspended. upon completion of this sequence, alarms will be reset to their default values.
Acción
Spacelabs Healthcare sent an Urgent - Medical Device Correction letter, dated 17 April 2015, to the US consignees via priority mail. On 4/24/2015, the firm will send the Urgent - Medical Device Correction letter (translated as necessary) via email to international subsidiaries and distributor of record. The Identified the affected product, problem and actions to be taken. Ultraview SL Command Modules which were upgraded with the Masimo SpO2 Option, Model 91496-M are affected. Ultraview SL Command Modules originally shipped with Masimo SpO2 are NOT affected. Spacelabs Healthcare will contact you to schedule a convenient time for Spacelabs to correct all of your facility's affected Command Modules at no cost.
For additional information or technical assistance, please contact:
Technical Support
Spacelabs Healthcare, Inc.
35301 SE Center St.
Snoqualmie, WA 98065
1-800-522-7025 and select 2 for Technical Support
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.
Catheters may not meet antimicrobial specification.
Acción
Medtronic (Covidien) issued recalll letter dated April 24, 2015, via FedEx overnight delivery to all affected customers. Customers were requested to quarantine and discontinue use of the affected devices. Customers were instructed to complete A Recalled Product Return Form for product returns. Customer Service will respond with a Return Goods Authorization (RGA) number and shipping documents
Customers with questions were instructed to contact their Medtronic representative or Medtronic Customer Service, Monday through Friday, 8am 6:30pm ET, at (800)-882-5878.
For questions regarding this recall call 203-492-5000.
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.
Catheters may not meet antimicrobial specification.
Acción
Medtronic (Covidien) issued recalll letter dated April 24, 2015, via FedEx overnight delivery to all affected customers. Customers were requested to quarantine and discontinue use of the affected devices. Customers were instructed to complete A Recalled Product Return Form for product returns. Customer Service will respond with a Return Goods Authorization (RGA) number and shipping documents
Customers with questions were instructed to contact their Medtronic representative or Medtronic Customer Service, Monday through Friday, 8am 6:30pm ET, at (800)-882-5878.
For questions regarding this recall call 203-492-5000.
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.
Catheters may not meet antimicrobial specification.
Acción
Medtronic (Covidien) issued recalll letter dated April 24, 2015, via FedEx overnight delivery to all affected customers. Customers were requested to quarantine and discontinue use of the affected devices. Customers were instructed to complete A Recalled Product Return Form for product returns. Customer Service will respond with a Return Goods Authorization (RGA) number and shipping documents
Customers with questions were instructed to contact their Medtronic representative or Medtronic Customer Service, Monday through Friday, 8am 6:30pm ET, at (800)-882-5878.
For questions regarding this recall call 203-492-5000.
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.
Catheters may not meet antimicrobial specification.
Acción
Medtronic (Covidien) issued recalll letter dated April 24, 2015, via FedEx overnight delivery to all affected customers. Customers were requested to quarantine and discontinue use of the affected devices. Customers were instructed to complete A Recalled Product Return Form for product returns. Customer Service will respond with a Return Goods Authorization (RGA) number and shipping documents
Customers with questions were instructed to contact their Medtronic representative or Medtronic Customer Service, Monday through Friday, 8am 6:30pm ET, at (800)-882-5878.
For questions regarding this recall call 203-492-5000.
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.
Catheters may not meet antimicrobial specification.
Acción
Medtronic (Covidien) issued recalll letter dated April 24, 2015, via FedEx overnight delivery to all affected customers. Customers were requested to quarantine and discontinue use of the affected devices. Customers were instructed to complete A Recalled Product Return Form for product returns. Customer Service will respond with a Return Goods Authorization (RGA) number and shipping documents
Customers with questions were instructed to contact their Medtronic representative or Medtronic Customer Service, Monday through Friday, 8am 6:30pm ET, at (800)-882-5878.
For questions regarding this recall call 203-492-5000.
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.
Catheters may not meet antimicrobial specification.
Acción
Medtronic (Covidien) issued recalll letter dated April 24, 2015, via FedEx overnight delivery to all affected customers. Customers were requested to quarantine and discontinue use of the affected devices. Customers were instructed to complete A Recalled Product Return Form for product returns. Customer Service will respond with a Return Goods Authorization (RGA) number and shipping documents
Customers with questions were instructed to contact their Medtronic representative or Medtronic Customer Service, Monday through Friday, 8am 6:30pm ET, at (800)-882-5878.
For questions regarding this recall call 203-492-5000.
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.
Catheters may not meet antimicrobial specification.
Acción
Medtronic (Covidien) issued recalll letter dated April 24, 2015, via FedEx overnight delivery to all affected customers. Customers were requested to quarantine and discontinue use of the affected devices. Customers were instructed to complete A Recalled Product Return Form for product returns. Customer Service will respond with a Return Goods Authorization (RGA) number and shipping documents
Customers with questions were instructed to contact their Medtronic representative or Medtronic Customer Service, Monday through Friday, 8am 6:30pm ET, at (800)-882-5878.
For questions regarding this recall call 203-492-5000.
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.
Catheters may not meet antimicrobial specification.
Acción
Medtronic (Covidien) issued recalll letter dated April 24, 2015, via FedEx overnight delivery to all affected customers. Customers were requested to quarantine and discontinue use of the affected devices. Customers were instructed to complete A Recalled Product Return Form for product returns. Customer Service will respond with a Return Goods Authorization (RGA) number and shipping documents
Customers with questions were instructed to contact their Medtronic representative or Medtronic Customer Service, Monday through Friday, 8am 6:30pm ET, at (800)-882-5878.
For questions regarding this recall call 203-492-5000.