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
Tube tracheostomy and tube cuff - Product Code JOH
Causa
Inflatable cuff tracheostomy tubes may leak air, resulting in inadequate ventilation.
Acción
Covidien issued an "Urgent Medical Device Recall" notification dated April 13, 2010. Consignees were alerted to the affected device. If an affected product is already in use, the firm recommends that the tube be replaced as soon as the patient's physician determines it is clinically appropriate. All affected product is to be returned to the firm.
For further Information, contact Covidien at 1-800-635-5267.
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
Radiation Treatment Planning System - Product Code MUJ
Causa
Under certain circumstances, xio will over-estimate dose in the region where the backup jaw is inside the mlc opening.
Acción
Elekta issued an undated "Important Safety Notice" to all affected sites via e-mail on 4/20/2010. The notice was also sent to the sites on 4/6/10 and 4/12/10 (for 4 sites) before the firm made the decision to recall. The letter explains the correct functioning of the system, the problem, when and why it occurs, the clinical impact, and the work around. Although not stated in the Safety Notice, a self-addressed postcard was enclosed for the customer to return as evidence they received and understood the notice. Sites that do not return the card will be contacted by phone.
Data from the United Kingdom is current through April 2019. All of the data comes from the Medicines and Healthcare products Regulatory Agency, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and the United Kingdom.
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
Tube tracheostomy and tube cuff - Product Code JOH
Causa
Inflatable cuff tracheostomy tubes may leak air, resulting in inadequate ventilation.
Acción
Covidien issued an "Urgent Medical Device Recall" notification dated April 13, 2010. Consignees were alerted to the affected device. If an affected product is already in use, the firm recommends that the tube be replaced as soon as the patient's physician determines it is clinically appropriate. All affected product is to be returned to the firm.
For further Information, contact Covidien at 1-800-635-5267.
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
Tube tracheostomy and tube cuff - Product Code JOH
Causa
Inflatable cuff tracheostomy tubes may leak air, resulting in inadequate ventilation.
Acción
Covidien issued an "Urgent Medical Device Recall" notification dated April 13, 2010. Consignees were alerted to the affected device. If an affected product is already in use, the firm recommends that the tube be replaced as soon as the patient's physician determines it is clinically appropriate. All affected product is to be returned to the firm.
For further Information, contact Covidien at 1-800-635-5267.
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 impactor may disassemble or detach during use. the detached piece may not be observed intraoperatively and may be left in the surgical site. complications may include pain, infection, and prolongation in surgery. these complications may also require revision surgery.
Acción
Zimmer issued "Urgent Medical Device Safety Alert" letters dated April 16, 2010 to Risk Managers, user facilities, Health Care Professionals and Zimmer Sales force. The users were informed to inspect the device for loosening. The alert also informed users to inspect the device after each use to verify that the device was intact. Customers were instructed to complete and return a User Facility Documentation Form. Zimmer will repair and replace all affected devices.
Customers can contact ZImmer, Inc. at 800 613-6131 concerning 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.
The impactor may disassemble or detach during use. the detached piece may not be observed intraoperatively and may be left in the surgical site. complications may include pain, infection, and prolongation in surgery. these complications may also require revision surgery.
Acción
Zimmer issued "Urgent Medical Device Safety Alert" letters dated April 16, 2010 to Risk Managers, user facilities, Health Care Professionals and Zimmer Sales force. The users were informed to inspect the device for loosening. The alert also informed users to inspect the device after each use to verify that the device was intact. Customers were instructed to complete and return a User Facility Documentation Form. Zimmer will repair and replace all affected devices.
Customers can contact ZImmer, Inc. at 800 613-6131 concerning 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.
The firm has determined that some of the packages could develop a breach of the seal in the sterile barrier pouches.
Acción
The firm sent an "Urgent Device Removal" letter dated 4/6/2010. The consignees were instructed to inventory the products on hand and return the recalled product to the manufacturer. More information is available at 1-800-613-6131.
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 has determined that some of the packages could develop a breach of the seal in the sterile barrier pouches.
Acción
The firm sent an "Urgent Device Removal" letter dated 4/6/2010. The consignees were instructed to inventory the products on hand and return the recalled product to the manufacturer. More information is available at 1-800-613-6131.
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 has determined that some of the packages could develop a breach of the seal in the sterile barrier pouches.
Acción
The firm sent an "Urgent Device Removal" letter dated 4/6/2010. The consignees were instructed to inventory the products on hand and return the recalled product to the manufacturer. More information is available at 1-800-613-6131.
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 has determined that some of the packages could develop a breach of the seal in the sterile barrier pouches.
Acción
The firm sent an "Urgent Device Removal" letter dated 4/6/2010. The consignees were instructed to inventory the products on hand and return the recalled product to the manufacturer. More information is available at 1-800-613-6131.
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
knee prosthesis instrument - Product Code LXH
Causa
One of the two posts on the anterior resection guide could disassociate from the main body of the part which has been determined to be caused by a fracture weld.
Acción
Stryker Urgent Product Recall letters dated April 5, 2010, were sent out via Federal Express to Stryker branches/agencies, Hospital Risk Management, hospital Chief of Orthopedics and Surgeons. All hospitals and surgeons that used the product in the last year were notified. Questions and/or concerns should be directed to Rich Wolyn at 201-972-2100.
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
Plasma, coagulation control - Product Code GGN
Causa
Indication not cleared or approved. the acceptable performance range published in the directcheck microcoagulation quality control package insert is incorrect.
Acción
Notification letters were sent vis Federal Express on April 15, 2010 to all distributors and end users to return unused product or to replace the package insert. Please direct questions ITC Technical Support at phone 800-631-5945 Ext. 4707.
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
pulse oximeter - Product Code DPZ
Causa
Ge healthcare has recently become aware that the
trusat pulse oximeter with external power supply does
not comply with current safety standards. it is possible
that the external power supply could leak electrical
current. this current could cause third degree burns or
an abnormal heart rhythm that, if untreated, could lead
to death.
Acción
Consignees were sent on 4/29/10 a GE Healthcare "Urgent Medical Device Correction" letter dated 4/22/10. The letter was addressed to Healthcare Administrator/Risk Manager, Chief of Nursing, Director of Biomedical Engineering, and Home Healthcare Provider.
The letter included the Safety Issue, Affected Product Details, Product Correction, Safety Instructions and Contact Information.
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.
Out of specification results for molecular weight or viscosity through the established expiration date.
Acción
Ferring Pharmaceuticals issued a "Medical Device Recall" notification dated April 16, 2010 by Federal Express to all distributors, retail pharmacies and physicians who received the product. Consignees were asked to stop distribution, return affected product to the firm and fax a completed Product Inventory Form to the firm.
For further information, contact Ferring Pharmaceuticals at 1-973-796-1600 or via fax at 1-973-796-1660.
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
Anesthetic cabinet, table, or tray - Product Code BRY
Causa
Some of the pitch shafts were not properly welded which results in the monitor becoming unlevel.
Acción
An Urgent: Medical Device Recall letter dated April 19, 2010 was sent to customers. It was recommended that customers continue use of the product unless the monitor becomes unlevel. The customer was notified that a Stryker Representative would contact their facility to coordinate a service call to inspect the affected units. Questions are directed to the firm via phone at 972-410-7617 or via email at .
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
plate, fixation, bone - Product Code HRS
Causa
The saw blades may not cut aggressively enough for their intended application therefore creating a risk that the saw could generate excessive heat, which may contribute to bone necrosis and/or non-union.
Acción
On April 14, 2010, Acumed began contacting consignees by telephone. On April 15, 2010, Acumed sent out the URGENT NOTICE: DEVICE RECALL Initial Notification letter and Recalled Product Status Form to their consignees. The letter describes the recall product as Ulnar Shorting Saw Blade-Hub Style S, Part no. 80-0499-S and Lot Codes.
The Initial Notification letter instructs consignees to return the product back to Acumed immediately and notify their sub-accounts (customers) if products have been further distributed. The consignees also are asked to fill out and send back the Recalled Product Status Form .
Customers should call the Customer Service at 1-888-627-9957 or e-mail to RecallNotification@acumed.net for any questions regarding the 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
Calculator/data processing module, for clinical use - Product Code JQP
Causa
A tabulation error in the integrated data management systems (idms) data management software that results in incorrect electronic quality control (eqc) summary reports: the operator and the device performance summary reports. the idms software is not used for the clinical management of individual patients.
Acción
ITC sent an URGENT MEDICAL DEVICE CORRECTION letter dated March 10, 2010 to Distributors and First Consignee End Users identifying the affected product and affected summary reports, the reason for recall, and the actions to be taken by the distributors and customers.
New Errata Instructions were enclosed with each letter and are to be put in the idms user guide for reference. The new instructions are to be followed when running reports for the ESV or TVT tests run by the Hemochron Response. The enclosed Customer Account Tracking Form is to be completed and returned to ITC indicating that the letter has been received and appropriate questions answered as to the use of the software system. Distributors are asked to check inventory for recalled product. If affected product is found, shipment should be stopped and placed on hold. Distributors should notify customers of the correction and provide them with a copy of the correction letter and updated instructions. This should be done by traceable mail. Distributors should return the account tracking form and return affected software disks for replacement.
Questions should be directed to ITC Technical Support at 800-631-5945.
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.
Channels in the packaging seal that can lead to suture degradation and loss of packaging integrity. recall z-0021-2009 was initiated in 2008. ethicon had decided to recall all sutures product during the may to june 2007 timeframe.
Acción
"Expansion of 2008 Voluntary Recall" notification letters dated April 20, 2010 were sent by second day UPS to customers, distributors, Materials Managers, Director of Surgical Services, and Directors of Risk Management. The letters state that the expansion includes 37 lots of products. The letters describe the product, problem and action t to be taken by customers. The customers were instructed to immediately discontinue use of any of the affected product and to remove from all inventory and returned to Stericycle. If they are not returning product, they should mail the enclosed business reply card to Stericycle. The customers should notify their end customers of this recall. If their end customers have the affected product they should first call 1-888-345-0483 to get appropriate shipping labels. THIS RECALL EXPANSION ONLY IMPACTS THE VICRYL RAPID SUTURE. THIS DOES NOT INCLUDE THE VICRYL* ADN VICRYL* PLUS PRODUCTS.
Please don't hesitate to contact Christie Bielinski directly at 908-218-2553 or via email at cbielinsi@its.jnj.com should you have any questions or require additional information.
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.
After repeated sterilizations product may become discolored and break including while in the medullary canal. synthes has determined that the medullary tube will be a single use item that is to be discarded after one sterilization cycle.
Acción
The recalling firm issued an Urgent medical Device Recall letter dated 4/9/10 to all trauma hospital accounts informing them of the problem and the need to return the products. All sales consultants were notified via email and letter.
Questions are directed to the company at 800-620-7025 x 5452 or 610-719-5452, or contact your Synthes Trauma Sales Consultant.
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
Tube tracheostomy and tube cuff - Product Code JOH
Causa
Inflatable cuff tracheostomy tubes may leak air, resulting in inadequate ventilation.
Acción
Covidien issued an "Urgent Medical Device Recall" notification dated April 13, 2010. Consignees were alerted to the affected device. If an affected product is already in use, the firm recommends that the tube be replaced as soon as the patient's physician determines it is clinically appropriate. All affected product is to be returned to the firm.
For further Information, contact Covidien at 1-800-635-5267.
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
Tube tracheostomy and tube cuff - Product Code JOH
Causa
Inflatable cuff tracheostomy tubes may leak air, resulting in inadequate ventilation.
Acción
Covidien issued an "Urgent Medical Device Recall" notification dated April 13, 2010. Consignees were alerted to the affected device. If an affected product is already in use, the firm recommends that the tube be replaced as soon as the patient's physician determines it is clinically appropriate. All affected product is to be returned to the firm.
For further Information, contact Covidien at 1-800-635-5267.
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
Tube tracheostomy and tube cuff - Product Code JOH
Causa
Inflatable cuff tracheostomy tubes may leak air, resulting in inadequate ventilation.
Acción
Covidien issued an "Urgent Medical Device Recall" notification dated April 13, 2010. Consignees were alerted to the affected device. If an affected product is already in use, the firm recommends that the tube be replaced as soon as the patient's physician determines it is clinically appropriate. All affected product is to be returned to the firm.
For further Information, contact Covidien at 1-800-635-5267.
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
Stimulator, autonomic nerve, implanted for epilepsy - Product Code LYJ
Causa
Battery life projection is inaccurate.
Acción
Safety Alert sent April 6, 2010 to all physicians of record for Model 103 or Model 104 generators and to all hospitals with non-implanted affected product, that explains the event, risks presented and recommended actions to take. The generator can be reprogrammed by the physician the next time the patient is seen in the clinic.
The issue can also be corrected during the initial implant procedure with the instructions provided.
Additional questions should be directed to the firm; United States customers can contact Clinical Technical Support at 866-882-8804.
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
Tube tracheostomy and tube cuff - Product Code JOH
Causa
Inflatable cuff tracheostomy tubes may leak air, resulting in inadequate ventilation.
Acción
Covidien issued an "Urgent Medical Device Recall" notification dated April 13, 2010. Consignees were alerted to the affected device. If an affected product is already in use, the firm recommends that the tube be replaced as soon as the patient's physician determines it is clinically appropriate. All affected product is to be returned to the firm.
For further Information, contact Covidien at 1-800-635-5267.