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
Staple, fixation, bone - Product Code JDR
Causa
The firm is recalling togglelocs and ziploops manufactured in may and july of 2014 as they were not processed following a standard work process, which resulted in complaints of sterile packaging not being sealed.
Acción
Biomet sent an Urgent Medical Device Recall Notice letter dated March 4, 2015 to affected customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to immediate locate and discontinued use of the product and its return to Biomet. Customers may contact Field Action Specialist, Regulatory Compliance,at (574) 372-1570.
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
virus test kit - Product Code N/A
Causa
Lusys laboratories is recalling ebola virus one step test kits to stop and prevent further use of these devices. the ebola virus one-step test kits have not yet been cleared, approved or authorized by the fda for diagnostics purposes.
Acción
LuSys Laboratories sent an Urgent Medical Device Recall letter dated March 13, 2015, to all affected customers informing them that the Ebola Virus One Step Test Kits are not approved by FDA for diagnostics purposes. The letter informs the customers of the problems identified and the actions to be taken. Customers were instructed to discontinue use and return the products to LuSys Laboratories. Customers are instructed to fax back the acknowledgement and Receipt Form to 1-858-866-1688.
For questions regarding this recall call 858-546-0902.
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
The firm was notified that the failure of the ups accessory devices used in conjunction with computed tomography x-ray systems and diagnostic imaging systems. may result in battery acid leakage, overheating and/or emission of fumes.
Acción
On 3/9/2015 the firm sent Urgent Field Safety Notices Medical Device Correction letters to their customers.
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
virus test kit - Product Code N/A
Causa
Lusys laboratories is recalling ebola virus one step test kits to stop and prevent further use of these devices. the ebola virus one-step test kits have not yet been cleared, approved or authorized by the fda for diagnostics purposes.
Acción
LuSys Laboratories sent an Urgent Medical Device Recall letter dated March 13, 2015, to all affected customers informing them that the Ebola Virus One Step Test Kits are not approved by FDA for diagnostics purposes. The letter informs the customers of the problems identified and the actions to be taken. Customers were instructed to discontinue use and return the products to LuSys Laboratories. Customers are instructed to fax back the acknowledgement and Receipt Form to 1-858-866-1688.
For questions regarding this recall call 858-546-0902.
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
virus test kit - Product Code N/A
Causa
Lusys laboratories is recalling ebola virus one step test kits to stop and prevent further use of these devices. the ebola virus one-step test kits have not yet been cleared, approved or authorized by the fda for diagnostics purposes.
Acción
LuSys Laboratories sent an Urgent Medical Device Recall letter dated March 13, 2015, to all affected customers informing them that the Ebola Virus One Step Test Kits are not approved by FDA for diagnostics purposes. The letter informs the customers of the problems identified and the actions to be taken. Customers were instructed to discontinue use and return the products to LuSys Laboratories. Customers are instructed to fax back the acknowledgement and Receipt Form to 1-858-866-1688.
For questions regarding this recall call 858-546-0902.
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
virus test kit - Product Code N/A
Causa
Lusys laboratories is recalling ebola virus one step test kits to stop and prevent further use of these devices. the ebola virus one-step test kits have not yet been cleared, approved or authorized by the fda for diagnostics purposes.
Acción
LuSys Laboratories sent an Urgent Medical Device Recall letter dated March 13, 2015, to all affected customers informing them that the Ebola Virus One Step Test Kits are not approved by FDA for diagnostics purposes. The letter informs the customers of the problems identified and the actions to be taken. Customers were instructed to discontinue use and return the products to LuSys Laboratories. Customers are instructed to fax back the acknowledgement and Receipt Form to 1-858-866-1688.
For questions regarding this recall call 858-546-0902.
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
virus test kit - Product Code N/A
Causa
Lusys laboratories is recalling ebola virus one step test kits to stop and prevent further use of these devices. the ebola virus one-step test kits have not yet been cleared, approved or authorized by the fda for diagnostics purposes.
Acción
LuSys Laboratories sent an Urgent Medical Device Recall letter dated March 13, 2015, to all affected customers informing them that the Ebola Virus One Step Test Kits are not approved by FDA for diagnostics purposes. The letter informs the customers of the problems identified and the actions to be taken. Customers were instructed to discontinue use and return the products to LuSys Laboratories. Customers are instructed to fax back the acknowledgement and Receipt Form to 1-858-866-1688.
For questions regarding this recall call 858-546-0902.
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
virus test kit - Product Code N/A
Causa
Lusys laboratories is recalling ebola virus one step test kits to stop and prevent further use of these devices. the ebola virus one-step test kits have not yet been cleared, approved or authorized by the fda for diagnostics purposes.
Acción
LuSys Laboratories sent an Urgent Medical Device Recall letter dated March 13, 2015, to all affected customers informing them that the Ebola Virus One Step Test Kits are not approved by FDA for diagnostics purposes. The letter informs the customers of the problems identified and the actions to be taken. Customers were instructed to discontinue use and return the products to LuSys Laboratories. Customers are instructed to fax back the acknowledgement and Receipt Form to 1-858-866-1688.
For questions regarding this recall call 858-546-0902.
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.
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
virus test kit - Product Code N/A
Causa
Lusys laboratories is recalling ebola virus one step test kits to stop and prevent further use of these devices. the ebola virus one-step test kits have not yet been cleared, approved or authorized by the fda for diagnostics purposes.
Acción
LuSys Laboratories sent an Urgent Medical Device Recall letter dated March 13, 2015, to all affected customers informing them that the Ebola Virus One Step Test Kits are not approved by FDA for diagnostics purposes. The letter informs the customers of the problems identified and the actions to be taken. Customers were instructed to discontinue use and return the products to LuSys Laboratories. Customers are instructed to fax back the acknowledgement and Receipt Form to 1-858-866-1688.
For questions regarding this recall call 858-546-0902.
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
virus test kit - Product Code N/A
Causa
Lusys laboratories is recalling ebola virus one step test kits to stop and prevent further use of these devices. the ebola virus one-step test kits have not yet been cleared, approved or authorized by the fda for diagnostics purposes.
Acción
LuSys Laboratories sent an Urgent Medical Device Recall letter dated March 13, 2015, to all affected customers informing them that the Ebola Virus One Step Test Kits are not approved by FDA for diagnostics purposes. The letter informs the customers of the problems identified and the actions to be taken. Customers were instructed to discontinue use and return the products to LuSys Laboratories. Customers are instructed to fax back the acknowledgement and Receipt Form to 1-858-866-1688.
For questions regarding this recall call 858-546-0902.
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
Ophthalmic femtosecond laser - Product Code OOE
Causa
Software anomaly on optimedica catalys system version 3.00.05 that may result in incorrect parameters provided for cataract incision surgeon templates and both eyes have the same parameters.
Acción
Abbott sent an Advisory Notice dated March 5, 2015, vis Fed Ex overnight to all affected customers. Out of State accounts will be notified through their distributor after letters are translated into local language.
Recall notification letters advise customers of issue with CATALYS System using software version 3.00.05. The letter actually covers two issues, the cataract templates being the same for both eyes, and a loss of suction during treatment that may result in scoring the cornea.
In both cases the issue is explained and users are advised to use mitigation listed to prevent injury. AMO is developing an update to software that will correct these issues and users will be advised when it is available for installation.
All users of the device should be made aware of the issues and each surgeon is requested to sign the acknowledgement form to verify their receipt and understanding. The acknowledgement for should be returned to Abbott Medical Optics per instructions. Questions in the US may be directed to AMO Technical support at 1-855-662-0911.
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.
Ge healthcare has recently become aware of a potential safety issue due to a collimator falling off a vg system during a quality control check, while the detectors were rotating. no injuries have been reported to date.
Acción
GE Healthcare sent an "Urgent Medical Device Correction" letter GEHC Ref# 40865 dated March 5, 2015. The letter was addressed to Managers of Nuclear Medecine, Hospital Administrators / Risk Managers and Managers of Radiology /Cardiology. The letter described the Safety Issue, Safety Instructions, Affected Product Details, Product Correction and Contact Information. For questions contact in the United States: 1-800-437-1171. For other countries, contact your local GE Healthcare Service Representative.
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
Cannula, ophthalmic - Product Code HMX
Causa
The metal cannula attached to the handpiece can rotate and become dislodged from the plastic handpiece.
Acción
Customers were notified via telephone and e-mail by 03/02/2015. The firm is requiring customers to complete a submitted response form and certificate of destruction for recalled devices by 03/31/2015. If recalled devices were further distributed the firm is asking customers to conduct a sub recall and forward notice of the recall. Public contact is Aspen Medical Europe Ltd, QA Department, Lynda McConaghy-QARA Manager, Lynda.McConaghy@aspenmedicaleurope.com , or +44 (0)1527 587716.
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.
Zimmer, inc is voluntarily recalling 22 lots of persona¿ anterior referencing sizer with locking boom, part number 42-5099-088-10. devices are being removed from distribution due to nonconforming to print specifications.
Acción
Zimmer sent an Urgent Medical device recall letter to all customers on March 10, 2015, via letter and email. The letter identified the product, the problem, and the action to be taken by the customer. Affected units will be inspected. Units that fail inspection will be physically destroyed/scrapped. Units that pass inspection will be re-etched and redistributed. If after reviewing this notification customers have further questions or concerns they were instructed to call the customer call center at 1-877-946-2761. Hours of operation are Monday through Friday, 8:00 a.m. through 5:00 p.m. EST.
For questions regarding this recall call 574-372-4487.
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
Specific aespire 7900 anesthesia machines have an increased likelihood of failure of the cpu circuit board. this could result in a blank display or loss of mechanical ventilation.
Acción
Consignees were sent a GE Healthcare "Urgent Medical Device Correction" letter GEHC Ref# 34064, dated February 27, 2015. The letter was addressed to Chief of Anesthesia, Health Care Administrator / Risk Manager and Director of Biomedical / Clinical Engineering. The letter described the Safety Issue, Safety Instructions, Affected Product Details, Product Correction and Contact Information. The letter stated that customers can continue to use the affected device in Manual Ventilation mode, and contact their local GE Healthcare Service Representative. GE Healthcare will correct all affected devices at no cost to the customers. A Service Representative will contact customers to arrange for the correction. For questions or concerns contact GE Healthcare Service at 1-800-437-1171, or your local Service Representative.
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
Flow cytometric reagents and accessories. - Product Code OYE
Causa
The circuit breakers on some bd facscalibur instruments may have the incorrect rated amperage (20 amps instead of 2 amps) causing the circuit breaker to fail to open in an over-current situation.
Acción
BD Biosciences sent an Important Product Recall letter on March 6, 2015 by certified mail and Field Change Notification (FCN FCB15-01-660312 directing Field Service Engineers to correct the circuit breaker is in process. Customers with questions were instruct to contact BD Customer Support at 1-877-232-8995 (prompt 2) in the United States. For customers outside the US were instructed to contact their local BD Biosciences representative or distributor. For questions regarding this recall call 408-954-6080.
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
Ophthalmic femtosecond laser - Product Code OOE
Causa
Device may experience loss of suction during treatment resulting in scoring the cornea during lens fragmentation.
Acción
Abbott Medical Optics (AMO) sent an Advisory Notice letter dated March 5, 2015 via FedEx overnight delivery to each Catalys Precision Laser System owner. The letter identified the affected product, problem and actions to be taken. Customers were instructed to complete and return the attached Acknowledgement Form. For questions contact AMO Technical Support at 1-855-662-0911.
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.
A potential issue was detected that could result in blood leakage from the gas outlet port in all lots of quadrox-id adult diffusion membrane oxygenator with bioline and softline coatings, custom tubing packs and diffusion membrane hls set advanced and hit set advanced models.
Acción
Maquet sent a "Field Safety Notice" accompanied by a Response Form to their affected customers on 3/5/2015 via FedEx. The Field Safety Notice identified the affected products/Part numbers and actions to be taken by the user. The customers were asked to complete the Field Safety Notice Response Form to acknowledge that they have received the notice. The completed notice can be faxed to 1-973-396-3607 or sent via email to fieldactions@maquet.com. For any questions, customers can contact their Maquet Sales Representative or Maquet Customer Service at 1-888-627-8383 (press option 2, followed by option 2), Monday through Friday, between the hours of 8:00 a.m. and 6:00 p.m. EST.