U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notas adicionales en la data
General surgery tray (kit) - Product Code LRO
Causa
The firm saw on the fda web site a recall by the manufacturer of the povidone iodine prep solution due to no microbial testing and product did not meet proper finished goods specifications.
Acción
Custom Medical Specialties sent an Urgent Medical Device Recall letter dated September 27, 2011 and a follow-up letter dated September 4, 2012 to all affected customers. The letter identified the affected product, problem, and actions to be taken. The letter requested that customers inspect inventory, discontinue use and return any remaining affected products. A Return Authorization Number and shipping number will be given to customer by calling 919-202-8462 ext 205. Customers were instructed to complete and return the attached Acknowledgement and Return Product form.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notas adicionales en la data
General surgery tray (kit) - Product Code LRO
Causa
The firm saw on the fda web site a recall by the manufacturer of the povidone iodine prep solution due to no microbial testing and product did not meet proper finished goods specifications.
Acción
Custom Medical Specialties sent an Urgent Medical Device Recall letter dated September 27, 2011 and a follow-up letter dated September 4, 2012 to all affected customers. The letter identified the affected product, problem, and actions to be taken. The letter requested that customers inspect inventory, discontinue use and return any remaining affected products. A Return Authorization Number and shipping number will be given to customer by calling 919-202-8462 ext 205. Customers were instructed to complete and return the attached Acknowledgement and Return Product form.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notas adicionales en la data
General surgery tray (kit) - Product Code LRO
Causa
The firm saw on the fda web site a recall by the manufacturer of the povidone iodine prep solution due to no microbial testing and product did not meet proper finished goods specifications.
Acción
Custom Medical Specialties sent an Urgent Medical Device Recall letter dated September 27, 2011 and a follow-up letter dated September 4, 2012 to all affected customers. The letter identified the affected product, problem, and actions to be taken. The letter requested that customers inspect inventory, discontinue use and return any remaining affected products. A Return Authorization Number and shipping number will be given to customer by calling 919-202-8462 ext 205. Customers were instructed to complete and return the attached Acknowledgement and Return Product form.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notas adicionales en la data
General surgery tray (kit) - Product Code LRO
Causa
The firm saw on the fda web site a recall by the manufacturer of the povidone iodine prep solution due to no microbial testing and product did not meet proper finished goods specifications.
Acción
Custom Medical Specialties sent an Urgent Medical Device Recall letter dated September 27, 2011 and a follow-up letter dated September 4, 2012 to all affected customers. The letter identified the affected product, problem, and actions to be taken. The letter requested that customers inspect inventory, discontinue use and return any remaining affected products. A Return Authorization Number and shipping number will be given to customer by calling 919-202-8462 ext 205. Customers were instructed to complete and return the attached Acknowledgement and Return Product form.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notas adicionales en la data
General surgery tray (kit) - Product Code LRO
Causa
The firm saw on the fda web site a recall by the manufacturer of the povidone iodine prep solution due to no microbial testing and product did not meet proper finished goods specifications.
Acción
Custom Medical Specialties sent an Urgent Medical Device Recall letter dated September 27, 2011 and a follow-up letter dated September 4, 2012 to all affected customers. The letter identified the affected product, problem, and actions to be taken. The letter requested that customers inspect inventory, discontinue use and return any remaining affected products. A Return Authorization Number and shipping number will be given to customer by calling 919-202-8462 ext 205. Customers were instructed to complete and return the attached Acknowledgement and Return Product form.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notas adicionales en la data
General surgery tray (kit) - Product Code LRO
Causa
The firm saw on the fda web site a recall by the manufacturer of the povidone iodine prep solution due to no microbial testing and product did not meet proper finished goods specifications.
Acción
Custom Medical Specialties sent an Urgent Medical Device Recall letter dated September 27, 2011 and a follow-up letter dated September 4, 2012 to all affected customers. The letter identified the affected product, problem, and actions to be taken. The letter requested that customers inspect inventory, discontinue use and return any remaining affected products. A Return Authorization Number and shipping number will be given to customer by calling 919-202-8462 ext 205. Customers were instructed to complete and return the attached Acknowledgement and Return Product form.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notas adicionales en la data
General surgery tray (kit) - Product Code LRO
Causa
The firm saw on the fda web site a recall by the manufacturer of the povidone iodine prep solution due to no microbial testing and product did not meet proper finished goods specifications.
Acción
Custom Medical Specialties sent an Urgent Medical Device Recall letter dated September 27, 2011 and a follow-up letter dated September 4, 2012 to all affected customers. The letter identified the affected product, problem, and actions to be taken. The letter requested that customers inspect inventory, discontinue use and return any remaining affected products. A Return Authorization Number and shipping number will be given to customer by calling 919-202-8462 ext 205. Customers were instructed to complete and return the attached Acknowledgement and Return Product form.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notas adicionales en la data
General surgery tray (kit) - Product Code LRO
Causa
The firm saw on the fda web site a recall by the manufacturer of the povidone iodine prep solution due to no microbial testing and product did not meet proper finished goods specifications.
Acción
Custom Medical Specialties sent an Urgent Medical Device Recall letter dated September 27, 2011 and a follow-up letter dated September 4, 2012 to all affected customers. The letter identified the affected product, problem, and actions to be taken. The letter requested that customers inspect inventory, discontinue use and return any remaining affected products. A Return Authorization Number and shipping number will be given to customer by calling 919-202-8462 ext 205. Customers were instructed to complete and return the attached Acknowledgement and Return Product form.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Terumo cardiovascular systems (terumo cvs) has received multiple reports since 2007 of various malfunctions of the arterial and cardioplegia monitors for the sarns modular
perfusion system 8000. the malfunctions can be broadly categorized as follows monitor power malfunctions, inability to measure pressure and inaccurate and/or false pressure
alarms.
if the malfunction of the arterial or cardio.
Acción
The firm, Terumo CVS, sent an "URGENT MEDICAL DEVICE RECALL" notice/Safety Advisory Alert dated September 24, 2012 and an addendum to the Operator's Manual to alert all affected Customers. The notice described the product, problem and actions to be taken. The customers were instructed to review this medical device recall notice; assure that all users are aware to this notice; place the addendum in the Operator's Manual just before page 4.1 and complete and return the attached Customer Response Form via Fax to: 1-734-741-6149 or email to:www.termuo-cvs.com.
If you have any questions or concerns contact Terumo CVS Customer Service at 1-800-521-1818; Monday - Friday, 8 AM - 6 PM ET.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Terumo cardiovascular systems (terumo cvs) has received multiple reports since 2007 of various malfunctions of the arterial and cardioplegia monitors for the sarns modular
perfusion system 8000. the malfunctions can be broadly categorized as follows monitor power malfunctions, inability to measure pressure and inaccurate and/or false pressure
alarms.
if the malfunction of the arterial or cardio.
Acción
The firm, Terumo CVS, sent an "URGENT MEDICAL DEVICE RECALL" notice/Safety Advisory Alert dated September 24, 2012 and an addendum to the Operator's Manual to alert all affected Customers. The notice described the product, problem and actions to be taken. The customers were instructed to review this medical device recall notice; assure that all users are aware to this notice; place the addendum in the Operator's Manual just before page 4.1 and complete and return the attached Customer Response Form via Fax to: 1-734-741-6149 or email to:www.termuo-cvs.com.
If you have any questions or concerns contact Terumo CVS Customer Service at 1-800-521-1818; Monday - Friday, 8 AM - 6 PM ET.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Terumo cardiovascular systems (terumo cvs) has received multiple reports since 2007 of various malfunctions of the arterial and cardioplegia monitors for the sarns modular
perfusion system 8000. the malfunctions can be broadly categorized as follows monitor power malfunctions, inability to measure pressure and inaccurate and/or false pressure
alarms.
if the malfunction of the arterial or cardio.
Acción
The firm, Terumo CVS, sent an "URGENT MEDICAL DEVICE RECALL" notice/Safety Advisory Alert dated September 24, 2012 and an addendum to the Operator's Manual to alert all affected Customers. The notice described the product, problem and actions to be taken. The customers were instructed to review this medical device recall notice; assure that all users are aware to this notice; place the addendum in the Operator's Manual just before page 4.1 and complete and return the attached Customer Response Form via Fax to: 1-734-741-6149 or email to:www.termuo-cvs.com.
If you have any questions or concerns contact Terumo CVS Customer Service at 1-800-521-1818; Monday - Friday, 8 AM - 6 PM ET.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Terumo cardiovascular systems (terumo cvs) has received multiple reports since 2007 of various malfunctions of the arterial and cardioplegia monitors for the sarns modular
perfusion system 8000. the malfunctions can be broadly categorized as follows monitor power malfunctions, inability to measure pressure and inaccurate and/or false pressure
alarms.
if the malfunction of the arterial or cardio.
Acción
The firm, Terumo CVS, sent an "URGENT MEDICAL DEVICE RECALL" notice/Safety Advisory Alert dated September 24, 2012 and an addendum to the Operator's Manual to alert all affected Customers. The notice described the product, problem and actions to be taken. The customers were instructed to review this medical device recall notice; assure that all users are aware to this notice; place the addendum in the Operator's Manual just before page 4.1 and complete and return the attached Customer Response Form via Fax to: 1-734-741-6149 or email to:www.termuo-cvs.com.
If you have any questions or concerns contact Terumo CVS Customer Service at 1-800-521-1818; Monday - Friday, 8 AM - 6 PM ET.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Terumo cardiovascular systems (terumo cvs) has received multiple reports since 2007 of various malfunctions of the arterial and cardioplegia monitors for the sarns modular
perfusion system 8000. the malfunctions can be broadly categorized as follows monitor power malfunctions, inability to measure pressure and inaccurate and/or false pressure
alarms.
if the malfunction of the arterial or cardio.
Acción
The firm, Terumo CVS, sent an "URGENT MEDICAL DEVICE RECALL" notice/Safety Advisory Alert dated September 24, 2012 and an addendum to the Operator's Manual to alert all affected Customers. The notice described the product, problem and actions to be taken. The customers were instructed to review this medical device recall notice; assure that all users are aware to this notice; place the addendum in the Operator's Manual just before page 4.1 and complete and return the attached Customer Response Form via Fax to: 1-734-741-6149 or email to:www.termuo-cvs.com.
If you have any questions or concerns contact Terumo CVS Customer Service at 1-800-521-1818; Monday - Friday, 8 AM - 6 PM ET.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Terumo cardiovascular systems (terumo cvs) has received multiple reports since 2007 of various malfunctions of the arterial and cardioplegia monitors for the sarns modular
perfusion system 8000. the malfunctions can be broadly categorized as follows monitor power malfunctions, inability to measure pressure and inaccurate and/or false pressure
alarms.
if the malfunction of the arterial or cardio.
Acción
The firm, Terumo CVS, sent an "URGENT MEDICAL DEVICE RECALL" notice/Safety Advisory Alert dated September 24, 2012 and an addendum to the Operator's Manual to alert all affected Customers. The notice described the product, problem and actions to be taken. The customers were instructed to review this medical device recall notice; assure that all users are aware to this notice; place the addendum in the Operator's Manual just before page 4.1 and complete and return the attached Customer Response Form via Fax to: 1-734-741-6149 or email to:www.termuo-cvs.com.
If you have any questions or concerns contact Terumo CVS Customer Service at 1-800-521-1818; Monday - Friday, 8 AM - 6 PM ET.
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.
Medical Specialties Distributors LLC sent an Urgent Medical Recall letter dated August 2, 2012, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to inspect their inventory and remove all affected product from use immediately. Further distribution of the affected product should be discontinued immediately. Customers were instructed to contact their customers and inform them of the recall; complete and return the acknowledgement form and fax to 781-344-8320 to arrange for a return and to contact the Customer Service Department at (800) 967-6400 with questions. For questions regarding this recall call 781-344-6000.
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
Sunquest is recalling the sunquest encompass versions 2.4 and later because the specimen collect time is displaying and printing one hour later than the actual collect time only when daylight saving time is active.
Acción
The firm, Sunquest, sent a "Urgent-Product Safety Notice: PSN-09-01" letter dated April 13, 2009 all their customers who purchase the Sunquest Encompass versions 2.4 and later. The letter informed the customers of the problem identified and the action to be taken. Customers were instructed to request software correction and to create a service request via client support webpage at www.sunquestinfo.com/supportweb. Then choose Submit a Service Request. Select Issue Type and select Software Request. When Software Request is selected, the Work Queue field automatically fills in with "Software Request." Promptly advise appropriate personnel.
Customers with questions can contact Client Support and Services at (877) 239-6337 for US and Canadian sites and at +44(0)0800-960-972 for international sites.
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 with respect to the innova 2121iq & innova 3131iq systems.
while performing a fluoroscopic acquisition with the innova 2121iq or innova 3131iq systems, there is a potential for loss of usable imaging mode which requires the system to restart in order to recover.
Acción
GE Healthcare sent an Urgent Medical Device Correction letter dated August 16, 2012, to all affected consignees. The letter described the Safety Issue, safety Instructions, Affected Product Details, Product Correction, and Contact Information. Consignees were instructed that hospital staff should wait for Photo or Image to appear on the display (when store photo function is performed) before start of the next short duration fluoroscopy acquisition. For questions customers were instructed to call:
United States (800) 437-1171
Japan: 0120 - 055 - 919
For other countries consignees should contact their local GE Healthcare Service Representative.
For questions regarding this recall call 262-513-4122.
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.
Bard access systems is recalling one lot of 16 fr hemostar xk long term hemodialysis catheters because they were identified with an incorrect expiration date, 03/2015 rather than 10/2013.
Acción
Bard Access Systems sent an "URGENT: *16 FR HEMOSTAR* LONG-TERM HEMODIALYSIS CATHETER RECALL" letter dated August 2012 to all affected customers. The letter identifies the product, problem, and actions to be taken by the customers. A Reply Form and Inventory Reconciliation Form was enclosed for customers to complete and return via fax to 1-801-522-5674. Contact BAS Customer Service at 1-800-290-1689 for questions regarding this recall.
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
Sterilizer, chemical - Product Code MED
Causa
Steris has been actively seeking devices for quick connect revalidation projects. steris was unable to obtain two (2) of the needed devices; these two devices represent the design of seven (7) models in one quick connect. due to the unavailability of these two validation devices, steris will remove 7 models from the labeling of qkc1692e and will re-label all qkc1692es in the field.
Acción
The firm, Steris, sent a "Voluntary Field Correction: Re-labeling of QKC1692E" letter on August 10, 2012 to its customers. The letter describes the product, problem and actions to be taken. The customers were instructed to follow the steps outlined in the letter to re-label the affected QKC1692E(s) and return the completed form by September 30. 2012 to: Regulatory Affairs Specialist via Kate_Beveridge@STERIS.com or via fax at (440) 350-7082.
If you have any questions, contact Director, Regulatory Affairs at 440-392-7519.
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 patient support may move in an unintended manner if the foot switch cover becomes damaged and impinges on the foot switch.
Acción
Philips Medical Systems (Cleveland), Inc. sent an Urgent - Medical Device Correction letter dated August 1, 2012 to all affected customers. The letter identified the affected product, problem and actions to be taked. The letter contained important information for the continued safe and proper use of your equipment. The letter stated that, a Field Service Engineer will visit each affected site to install the hardware upgrade. For further information or support concerning this issue contact your local Philips representative or local Philips Health office. For North America and Canada contact Customer Care Solution Center (1-800-722-9377), option 5: Enter Site ID or Follow the prompts).
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
Medical Image Storage Device - Product Code LLZ
Causa
Loss of patient data can occur under certain circumstances due to misconfiguration of dicomstore configured with agfa's medical image storage devices - media purge daemon (mpd) and cardiovascular purge service (cps).
Acción
On 8/9/2012 AGFA Healthcare issued an "URGENT FIELD SAFETY NOTICE" letter to consignees. This letter describes the problem and mitigation. Acknowledgment, via FAX-Back or email, that the information was received and understood was also required from the consignees
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
The firm is recalling one lot of 392-09-706, 3dknee e+ tibial insert, 9 mm, size 6, right. the shelf life labeling of specific lots for a component were found to be incorrect and were found to be expired.
Acción
DJO Global sent an Urgent Field Safety Notice dated August 9, 2012, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to forward the Notice to all those who need to be aware within their organization or to any organization where the potentially affected product has been transferred. Customers were instructed to contact the firm to place a replacement order and receive an RMA number. For questions customers were asked to call 512-834-6255.
For questions regarding this recall call 512-832-9500.
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
Rod, fixation, intramedullary and accessories - Product Code HSB
Causa
There is a possibility that the iskd limb lengthener may stop distracting post-operatively during treatment, which may result in premature bone consolidation (limb not achieving the desired length) leading to revision surgery to remove and/or replace the device.
Acción
Orthofix sent an Urgent Product Recall Notification letter dated August 6, 2012, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to discontinue distribution of devices, identify the affected and remove from their inventory, and returned to the firm. Credit will be issued upon receipt of the returned product. Customers were asked to take the actions listed in the enclosed Product Return Instructions immediately. Customers with questions should contact Orthofix Customers Service by telephone at 800-266-3349 or 214-937-2047.
For questions regarding this recall call 214-937-2509.
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 potential for the sterility of the product to be compromised.
Acción
Intuitive Surgical sent a "MEDICAL DEVICE CORRECTION" letter dated August 9, 2012 to all affected customers. The letter identifies the product, problem, and actions to be taken by the customers. An Acknowledgement Form was included for customers to complete and return via fax to (408) 716-3040. Contact Customer Service at 1-800-876-1310 for questions regarding this recall.
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
Transport, patient, powered - Product Code ILK
Causa
The seat could break as a result of damage resulting from a seat belt being trapped underneath the foldable part of the seat when the seat belt is not buckled.
Acción
The firm, ThyssenKrupp Access sent an "IMPORTANT SAFETY AND PRODUCT USE INFORMATION" letter dated August 6, 2012 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers.
Contact the firm at 1-800-925-3100 ext. 5484 for assistance regarding this recall.