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.
Customer complaints of a leak between the blood and water compartments of the heat exchanger used in the oxygenators due to prolonged contact of the heat exchangers with sodium chloride causing micro-holes.
Acción
Urgent Field Safety Notices dated December 2, 2011 were sent to customers. The letter identified the affected products and described the problem. The letter also provided additional directions to the Instructions for Use in order to minimize risk and clarify priming procedures. Customers were to communicate the new warning to all personnel in the use of the affected products and complete the Customer Response Form. The form should be returned via fax or e-mail. Questions should be directed towards Sorin Group Customer Service at 1-800-650-2623.
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.
Customer complaints of a leak between the blood and water compartments of the heat exchanger used in the oxygenators due to prolonged contact of the heat exchangers with sodium chloride causing micro-holes.
Acción
Urgent Field Safety Notices dated December 2, 2011 were sent to customers. The letter identified the affected products and described the problem. The letter also provided additional directions to the Instructions for Use in order to minimize risk and clarify priming procedures. Customers were to communicate the new warning to all personnel in the use of the affected products and complete the Customer Response Form. The form should be returned via fax or e-mail. Questions should be directed towards Sorin Group Customer Service at 1-800-650-2623.
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.
Customer complaints of a leak between the blood and water compartments of the heat exchanger used in the oxygenators due to prolonged contact of the heat exchangers with sodium chloride causing micro-holes.
Acción
Urgent Field Safety Notices dated December 2, 2011 were sent to customers. The letter identified the affected products and described the problem. The letter also provided additional directions to the Instructions for Use in order to minimize risk and clarify priming procedures. Customers were to communicate the new warning to all personnel in the use of the affected products and complete the Customer Response Form. The form should be returned via fax or e-mail. Questions should be directed towards Sorin Group Customer Service at 1-800-650-2623.
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.
Various presource kits contain a pre-assembled filter and anesthesia circuit that may contain outer plastic packaging on one or more components. if the packaging is removed without disassembling the components, remnants of the plastic from the packaging material may become lodged in the filter potentially causing an obstruction of airflow.
Acción
Affected consignees were notified with a letter, dated March 26, 2013, sent via FedEx Priority, of this action. Cardinal Sales Representatives will also be advised and will verbally communicate the action to affected customers. The letter identified the affected product and the problem. Customers are to locate any affected product and quarantine them. In addition, clinicians should be informed of the issue; and, warning labels should be affixed to the front of each kit instructing users to remove and discard the Anesthesia Circuit and Filter Assembly. In order to confirm receipt of this action and completion of labeling the product, the enclosed Acknowledgement Form should be completed and returned to the number provided.
If customers do now wish to accept overlabeled product or to overlabel the product in their possession, they are to contact Presource Sales Operations at 800-766-0706, or their sales representative for further instruction. Customers are to contact Cardinal Health Quality Systems at 800-292-9332, if they have any questions or need special assistance.
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.
Customer complaints of a leak between the blood and water compartments of the heat exchanger used in the oxygenators due to prolonged contact of the heat exchangers with sodium chloride causing micro-holes.
Acción
Urgent Field Safety Notices dated December 2, 2011 were sent to customers. The letter identified the affected products and described the problem. The letter also provided additional directions to the Instructions for Use in order to minimize risk and clarify priming procedures. Customers were to communicate the new warning to all personnel in the use of the affected products and complete the Customer Response Form. The form should be returned via fax or e-mail. Questions should be directed towards Sorin Group Customer Service at 1-800-650-2623.
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.
Customer complaints of a leak between the blood and water compartments of the heat exchanger used in the oxygenators due to prolonged contact of the heat exchangers with sodium chloride causing micro-holes.
Acción
Urgent Field Safety Notices dated December 2, 2011 were sent to customers. The letter identified the affected products and described the problem. The letter also provided additional directions to the Instructions for Use in order to minimize risk and clarify priming procedures. Customers were to communicate the new warning to all personnel in the use of the affected products and complete the Customer Response Form. The form should be returned via fax or e-mail. Questions should be directed towards Sorin Group Customer Service at 1-800-650-2623.
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.
Customer complaints of a leak between the blood and water compartments of the heat exchanger used in the oxygenators due to prolonged contact of the heat exchangers with sodium chloride causing micro-holes.
Acción
Urgent Field Safety Notices dated December 2, 2011 were sent to customers. The letter identified the affected products and described the problem. The letter also provided additional directions to the Instructions for Use in order to minimize risk and clarify priming procedures. Customers were to communicate the new warning to all personnel in the use of the affected products and complete the Customer Response Form. The form should be returned via fax or e-mail. Questions should be directed towards Sorin Group Customer Service at 1-800-650-2623.
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
Accelerator, linear, medical - Product Code IYE
Causa
An event has been reported to varian which entails excessive connector resistance, which caused the actual jaw positions to differ from the intended jaw positions without warning the operator.
Acción
Varian Medical Systems sent an Urgent Medical Device Correction - Urgent Field Safety Notice dated November 28, 2011 ***Expanded to include product #2 on December 16, 2011***, to all affected customers.
***12-12-12, AMENDED INFO ***: An additional letter was sent to consignees on 11/5/12 that Varian identified as also being affected by the recall.***
The letter identified the product, the problem, and the action to be taken by the customer.
Customers were instructed to establish a comprehensive quality assurance program before beginning treatments for the day, quality assurance tests must be performed.
Additionally, any discrepancies in imaging field sizes vs planned field size should be brought to the attention of the medical physicist for investigation before treatment continues.
Customers were asked to complete the attached Proof of Notification or Receipt Verification Card once they have read the document and return it to Varian Medical Systems.
For question regarding this recall:
USA and Canada 1-888-827-4265
Europe +41 41 749 8844
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.
Customer complaints of a leak between the blood and water compartments of the heat exchanger used in the oxygenators due to prolonged contact of the heat exchangers with sodium chloride causing micro-holes.
Acción
Urgent Field Safety Notices dated December 2, 2011 were sent to customers. The letter identified the affected products and described the problem. The letter also provided additional directions to the Instructions for Use in order to minimize risk and clarify priming procedures. Customers were to communicate the new warning to all personnel in the use of the affected products and complete the Customer Response Form. The form should be returned via fax or e-mail. Questions should be directed towards Sorin Group Customer Service at 1-800-650-2623.
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
Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation - Product Code OAE
Causa
Biosense webster, inc. has recently become aware of the omission of the following two warning and precaution statements on the instructions for use (ifu) for the above catheter:
1. if phrenic nerve location is a concern, precautionary measures are recommended to evaluate the proximity of the nerve to the ablation electrode, such as pacing maneuvers.
2. to minimize risk of atrio-esophageal fist.
Acción
Biosense Webster, Inc. sent an Urgent Field Safety Notice letter dated Novembe 22, 2010, to all affected customers. The letter identified the product, the problem, and the action to be taken by the consignee. Consignees were advised to continue use of the affected product and that no further action is required on their part. Consignees were advised that the updated IFU can be found at www.jnjgatewayifu.com. Consignees were instructed to contact their local Biosense Webster representative if they have any questions or require additional information.
For questions regarding this recall call 909-839-8604.
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
Pump, blood, cardiopulmonary bypass, non-roller type - Product Code KFM
Causa
Customer complaints of a leak between the blood and water compartments of the heat exchanger used in the oxygenators due to prolonged contact of the heat exchangers with sodium chloride causing micro-holes.
Acción
Urgent Field Safety Notices dated December 2, 2011 were sent to customers. The letter identified the affected products and described the problem. The letter also provided additional directions to the Instructions for Use in order to minimize risk and clarify priming procedures. Customers were to communicate the new warning to all personnel in the use of the affected products and complete the Customer Response Form. The form should be returned via fax or e-mail. Questions should be directed towards Sorin Group Customer Service at 1-800-650-2623.
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
Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation - Product Code OAE
Causa
Biosense webster, inc. has recently become aware of the omission of the following two warning and precaution statements on the instructions for use (ifu) for the above catheter:
1. if phrenic nerve location is a concern, precautionary measures are recommended to evaluate the proximity of the nerve to the ablation electrode, such as pacing maneuvers.
2. to minimize risk of atrio-esophageal fist.
Acción
Biosense Webster, Inc. sent an Urgent Field Safety Notice letter dated Novembe 22, 2010, to all affected customers. The letter identified the product, the problem, and the action to be taken by the consignee. Consignees were advised to continue use of the affected product and that no further action is required on their part. Consignees were advised that the updated IFU can be found at www.jnjgatewayifu.com. Consignees were instructed to contact their local Biosense Webster representative if they have any questions or require additional information.
For questions regarding this recall call 909-839-8604.
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
Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation - Product Code OAE
Causa
Biosense webster, inc. has recently become aware of the omission of the following two warning and precaution statements on the instructions for use (ifu) for the above catheter:
1. if phrenic nerve location is a concern, precautionary measures are recommended to evaluate the proximity of the nerve to the ablation electrode, such as pacing maneuvers.
2. to minimize risk of atrio-esophageal fist.
Acción
Biosense Webster, Inc. sent an Urgent Field Safety Notice letter dated Novembe 22, 2010, to all affected customers. The letter identified the product, the problem, and the action to be taken by the consignee. Consignees were advised to continue use of the affected product and that no further action is required on their part. Consignees were advised that the updated IFU can be found at www.jnjgatewayifu.com. Consignees were instructed to contact their local Biosense Webster representative if they have any questions or require additional information.
For questions regarding this recall call 909-839-8604.
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 safety issue associated with the probe of your logic p6 system that may impact patient safety.
ge logic p6 probe head has a possibility to cause burn injuries to patients or operators.
Acción
GE Healthcare sent an "URGENT MEDICAL DEVICE CORRECTION" letter dated December 23, 2011 to all affected customers. The letter identifies the product, problem, and actions to be taken by the customers. The letter instructs customers to discontinue use of the affected product. Contact the GE Support Center at 1-800-321-7937 or your local GE Healthcare service representative for questions regarding this issue.
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
Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation - Product Code OAE
Causa
Biosense webster, inc. has recently become aware of the omission of the following two warning and precaution statements on the instructions for use (ifu) for the above catheter:
1. if phrenic nerve location is a concern, precautionary measures are recommended to evaluate the proximity of the nerve to the ablation electrode, such as pacing maneuvers.
2. to minimize risk of atrio-esophageal fist.
Acción
Biosense Webster, Inc. sent an Urgent Field Safety Notice letter dated Novembe 22, 2010, to all affected customers. The letter identified the product, the problem, and the action to be taken by the consignee. Consignees were advised to continue use of the affected product and that no further action is required on their part. Consignees were advised that the updated IFU can be found at www.jnjgatewayifu.com. Consignees were instructed to contact their local Biosense Webster representative if they have any questions or require additional information.
For questions regarding this recall call 909-839-8604.
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.
Customer complaints of a leak between the blood and water compartments of the heat exchanger used in the oxygenators due to prolonged contact of the heat exchangers with sodium chloride causing micro-holes.
Acción
Urgent Field Safety Notices dated December 2, 2011 were sent to customers. The letter identified the affected products and described the problem. The letter also provided additional directions to the Instructions for Use in order to minimize risk and clarify priming procedures. Customers were to communicate the new warning to all personnel in the use of the affected products and complete the Customer Response Form. The form should be returned via fax or e-mail. Questions should be directed towards Sorin Group Customer Service at 1-800-650-2623.
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
Component defect. when the user is operating the control panel, he/she may inadvertently activate the wrong switch on the control panel which could, in turn, cause the patient couch to move in an unwanted direction.
Acción
Philips sent an 'URGENT - Medical Device Correction Ingenuity CT' letter dated November 15, 2011. The letter describes the affected product, problem, hazard involved and actions to be taken by the customer and user. In this case, the customers are advised that extra care should be taken when using the 8-way Gantry Panel switch so as to avoid inadvertently activating an unintended switch resulting in unwanted (couch) movement. The letter notifies the customers that a Philips representative will be visiting each customer site and installing a new control panel through a Field Change Order. For further information or support concerning this issue contact your local Philips representative or local Philips Healthcare office. For North America and Canada contact the Customer Care Solutions Center at (1-800-722-9377, option 5; enter site ID or follow 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.
Customer complaints of a leak between the blood and water compartments of the heat exchanger used in the oxygenators due to prolonged contact of the heat exchangers with sodium chloride causing micro-holes.
Acción
Urgent Field Safety Notices dated December 2, 2011 were sent to customers. The letter identified the affected products and described the problem. The letter also provided additional directions to the Instructions for Use in order to minimize risk and clarify priming procedures. Customers were to communicate the new warning to all personnel in the use of the affected products and complete the Customer Response Form. The form should be returned via fax or e-mail. Questions should be directed towards Sorin Group Customer Service at 1-800-650-2623.
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
Sterilant, medical devices - Product Code MED
Causa
Software deficiency. steris identified that water specifications were not being met at some of their customer sites. critical parameters for initiating cycles are: water quality, water pressure and water temperature. failure to meet these criteriae may lead to cycle aborts by the system 1e liquid chemical sterilant processing system. the firm intends to perform a software field correction which.
Acción
The firm, STERIS Corp. prepared an "URGENT VOLUNTARY FIELD CORRECTION NOTICE" letter dated December 8, 2011. The firm intends to send the letter to its customers upon STERIS' receipt of 510(k) clearance from FDA. The letter includes a description of the Product-SYSTEM ¿¿ Liquid Chemical Sterilant Processing System, problem and actions taken. The customers were instructed to in case of an incomplete or cancelled cycle, reprocess devices in the cycle following the directions in the Operator manual. The letter also states that STERIS Corporation will install updated software on the affected system, and will be providing the customers with a new Operator Manual reflecting the revised wording resulting from the installation of the new software. For further information or if they have any questions regarding the firms visit to their facility, contact STERIS Field Service Dispatch at 1-800-333-8828.
If you have questions regarding this matter, contact Director Low Temperature Sterilization, at 440-392-7455.
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
Calibrators, drug mixture - Product Code DKB
Causa
Multi analyte urine dau cutoff calibrator gives a decreased absorbance reading due to a loss of the bzo (oxazepam) analyte from the solution and may cause false positive readings.
Acción
The firm, Lin-Zhi International, Inc., sent a notice by email dated August 23, 2011 to all customers. The notice described the product, problem and actions to be taken. Lin-Zhi will contact the customers to determine whether they want replacement BZO calibrators and controls immediately or if they are willing to wait a minimum of four weeks for a new lot of the Multi-Analyte Urine Cutoff Calibrators. The customers were instructed to contact Lin-Zhi with their replacement request.
The notice also stated that the Lin-Zhi has plans to create more stringent QC standards and further R&D; regarding stabilization of this analyte in solution in its calibrators of controls containing BZO.
If you have any questions or concerns regarding how this situation is being handled or the outcome, contact Lin-Zhi at (408)732-3856; email: customerservice@lin-zih.com or webpage: www.lin-zhi.com.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
The lithium heparin tubes may have a contamination with edta potassium.
Acción
Greiner Bio-One sent a "RECALL OF LITHIUM HEPARIN TUBES WITH EDTA CONTAMINATION" letter dated December 13, 2011 to all affected customers. The letter describes the product, problem, and actions to be taken by the customers. The letter instructs customers to complete an attached Product Disposition Site Confirmation Form and to fax the form to 800-726-0052. This form will confirm that customers have discarded/destroyed all affected product. The firm will replace the product after receipt of the form. Contact the firm at 800-515-8112 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
System, nuclear magnetic resonance imaging - Product Code LNH
Causa
Ge healthcare has recently become aware of a potential safety issue due to the failure of the transfer board release lever associated with the or compatible patient transfer table of your optima mr450w mr surgical suite.
Acción
GE Healthcare, sent a Urgent Medical Device Correction letter dated December 15, 2011, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer.
The customer was instructed discontinue use of OR Compatible table until issue is corrected.
GE Healthcare will correct all affected systems by providing a replacement table cradle incorporating design changes to the cradle release lever mechanism at no cost to you. A GE Healthcare service representative will contact you to arrange for this correction.
Contact your local service representative if you have any questions concerning this notification. For further questions please 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.
Notas adicionales en la data
Suture removal kit - Product Code MCZ
Causa
The firm has determined that there is a possibility that packaging seals may be compromised. the issue could result in an injury to the patient due to product contamination or loss of sterility condition.
Acción
Customed Inc sent an Urgent Medical Device Recall letter dated December 8, 2011 to distributors via e-mail; then by certified (return and receipt) mail. The letter identified the product, description of problem, and actions to be taken. The letter included the following instructions:
1. Product should be removed from sale (Quarantine them) and cease distribution. Products affected shall NOT be used.
2. Return the enclosed acknowledgement form to Customed, Inc. Recall Coordinator whether or not the consignee has affected products.
3. If products has been futher distributed, sub-recall products - It is extremely important to notify your customers of this action by including a copy of this leller along with your formal notification. Please, instruct your customer to follow your directions for credit/replacemenl if they purchased the product from you.
For qucstions. contact Cuslomed, Inc. Recall Coordinator at 787-622-5151 Ext. 7510.
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
Unit, electrosurgical, endoscopic (with or without accessories) - Product Code KNS
Causa
Less than optimal thickness in the plastic housing holding the electrode in the olympus working elements.
Acción
Olympus America Inc. sent an "URGENT: MEDICAL DEVICE WITHDRAWAL" letter dated December 27, 2011 to all affected customers. The letter identifies the product, problem, and actions to be taken by the customers. The letter instructs customers to inspect their inventory for the affected product and discontinue use of any affected product discovered. Customers should contact the Gyrus ACMI Customer Service Department at 1-888-524-7266 for credit or replacement of the product. Additionally, an Olympus Working Elements Withdrawal form was enclosed for customers to complete and fax to 484-896-7128. Contact the firm at 484-896-5688 for questions regarding this notice.
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 there is a possibility that packaging seals may be compromised. the issue could result in an injury to the patient due to product contamination or loss of sterility condition.
Acción
Customed Inc sent an Urgent Medical Device Recall letter dated December 8, 2011 to distributors via e-mail; then by certified (return and receipt) mail. The letter identified the product, description of problem, and actions to be taken. The letter included the following instructions:
1. Product should be removed from sale (Quarantine them) and cease distribution. Products affected shall NOT be used.
2. Return the enclosed acknowledgement form to Customed, Inc. Recall Coordinator whether or not the consignee has affected products.
3. If products has been futher distributed, sub-recall products - It is extremely important to notify your customers of this action by including a copy of this leller along with your formal notification. Please, instruct your customer to follow your directions for credit/replacemenl if they purchased the product from you.
For qucstions. contact Cuslomed, Inc. Recall Coordinator at 787-622-5151 Ext. 7510.