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.
Fine plastic strands on inner surface of the infant neonatal airway adapter may become dislodged and inhaled by the patient.
Acción
The firm, Oridion, sent an "Microstream Filterline Field Correction Notice" letter dated March 25, 2011 to its US and foreign customers via telephone, email with the documentation discussed in the call, and letter. The letter described the product, problem and actions to be taken. The customers were instructed to place all affected product held in their inventory on ship hold; gather these units in their inventory and at the customer sites and exchange with the new product; inspect filter line starter (sample) kits shipped with Capnostream 20 and Microcap patient monitors for affected product, if affected Infant/Neonatal filter lines are found, remove them from the starter (sample) kit; send a purchase order in order to obtain replacement product for units in their stock and at customers sites, and complete and return the Inventory Reporting Form Excel Spread Sheet within two weeks of receiving the email even if they or their customers do not have the affected inventory.
Oridion shall conduct a removal of the products from the related production lots from the field and an immediate replacement with product from subsequent production lots that meet all requirements. This action will be conducted by Oridion's distributors or by Oridion directly in some cases.
Oridion anticipates that new product will be available for shipment during the week of April 4th.
Questions regarding the recall can be directed towards the Customer Service Coordinator at: 1-888-674-3466 x1234 or NA-FCA@oridion.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.
Fine plastic strands on inner surface of the infant neonatal airway adapter may become dislodged and inhaled by the patient.
Acción
The firm, Oridion, sent an "Microstream Filterline Field Correction Notice" letter dated March 25, 2011 to its US and foreign customers via telephone, email with the documentation discussed in the call, and letter. The letter described the product, problem and actions to be taken. The customers were instructed to place all affected product held in their inventory on ship hold; gather these units in their inventory and at the customer sites and exchange with the new product; inspect filter line starter (sample) kits shipped with Capnostream 20 and Microcap patient monitors for affected product, if affected Infant/Neonatal filter lines are found, remove them from the starter (sample) kit; send a purchase order in order to obtain replacement product for units in their stock and at customers sites, and complete and return the Inventory Reporting Form Excel Spread Sheet within two weeks of receiving the email even if they or their customers do not have the affected inventory.
Oridion shall conduct a removal of the products from the related production lots from the field and an immediate replacement with product from subsequent production lots that meet all requirements. This action will be conducted by Oridion's distributors or by Oridion directly in some cases.
Oridion anticipates that new product will be available for shipment during the week of April 4th.
Questions regarding the recall can be directed towards the Customer Service Coordinator at: 1-888-674-3466 x1234 or NA-FCA@oridion.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.
Notas adicionales en la data
Accelerator, linear, medical - Product Code IYE
Causa
An issue was identified with the gantry rotation direction when creating opposing field within the rt chart function of aria, or possibly with third party planning systems and delivering the plan at 4ditc.
Acción
Varian Medical Systems, Inc. Oncology Systems sent Urgent Medical Device Correction Field Safety Notice letters on March 9, 2011, to all affected customers.
***12-20-12, AMENDED INFO ***: An additional letter was sent to consignees on 11/5/12 that Varian identified as also being affected by the recall.***
The letters identifeid the product, the problem, and the action to be taken by the customer.
Customers were instructed to:
Manually enter the gantry angel 0.0 when the plan indicates angel 0.0. Manual entry is only allowed to one decimal place, so the range that triggers the issue cannot be created if the keyboard is ued to enter the gantry angel.
Users with third party plan sources should verify whether gantry angles with two or more decimal places are supported. If so, customers may be affected by this issue, and should take steps suited to the device.
In all cases, the display at the Treatment console is indicative of what direction the gantry will move - users are advised to be especially attentive to these values, particulary when non-zero couch rotation values are used.
Users are advised to always run a simulation of the plan, including all plan motions, at the treatment unit prior to first patient treatment.
For further clarification customers were insturcted to contact their local Varian Customer Support District Manager.
For questions regarding this recall call 650-424-6471.
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
Kit, i.V. Start - Product Code LRS
Causa
This voluntary recall was initiated because the vials of bacteriostatic sodium chloride injection, usp, 0.9% utilized to make the products may contain visible particulates.
Acción
Centurion Medical Products Corporation issued press on April 1, 2011, and sent an Urgent Voluntary Recall letter dated March 15, 2011, 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 use of the kits immediately and instructions were provided for the return of the kits.
Customers were also asked to complete a form to fax or email back to the firm regarding the number of kits the firm has in their possession.
Customers were instructed to provide recall notification to other firm's who received the recalled kits from their direct account.
For any questions regarding this recall call 631-924-4000, ext 142.
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
Arthroscope - Product Code HRX
Causa
Device was shipped past the labeled expiration date.
Acción
On 3/23/2011, the firm initiated the recall and sent Urgent Notice: Device Recall letters identifying the affected product and explaining the reason for the recall. The letter asks customers not to use the affected product with the lot number 0001653390. The firm will replace any affected product at no cost to the customer. A Medtronic Spine Sales representative will assist with the segregation and return of the affected product. They will also assist the customer with contacting Medtronic Spine Customer Service to return the affected product. Included with the letter was a reconciliation form with instructions regarding the affected product. Questions regarding the letter should be directed to Customer Service at 866-959-7466.
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
Varian has identified an anomaly whereby, following prolonged use, the screw fastener holding the wedge body to the tray may fail.
Acción
The firm, Varian Medical, sent an "Urgent Medical Device Correction" Letter dated March 28, 2011 to its customers. The letter described the product, problem and actions to be taken. The customers were instructed to immediately inspect all hard wedges for missing or sheared screw fasteners, if any wedge is found to have one or more missing or sheared screw fasteners, remove the wedge from use and notify Varian immediately; inspect all hard wedges for loose screw fasteners, and retighten as necessary, and implement a program of monthly inspection of wedges for loose or missing hardware. The customers were also instructed to advise the appropriate personnel working in their Radiotherapy Department of the content of this letter.
Varian Service shall immediately begin an interim action to replace screw fasteners on all hard wedges for Clinacs installed prior to January 2004. Varian Service will contact the customers to arrange for the inspection visit.
Varian also stated that they shall continue their Investigation of this issue to further clarify the exact conditions under which the wedge screw fasteners may fail, and to analyze possible final solutions. Varian will notify the customers when final determinations are made.
If you require further clarification, please feel free to contact your local Varian Customer Support Services Manager and/or USA and Canada at 1-888-4265; Europe: +41 41 749 8844; or email: North America: support-americas@varian.com; Australia/New Zealand: support-anz@varian.com; Europe: support emea@varian.com; South East Asia: seasia.apps.helpdesk@varian.com; China/Asia: china.apps.Helpdesk@varian.com; Japan: Japan.apps helpdesk@varian.com; Latin America: soporte.al@varian.com, a d Internet: Oncology Systems-www.myvarian.com or Varian Medical Systems - www.varian.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.
Notas adicionales en la data
Device, digital image storage, radiological - Product Code LMB
Causa
There is a potential safety issue in regard to data transfer between lantis ois system and the hospital information system (his) when the hl7 (adt) interfact is used.
Acción
Siemens sent an Urgent Medical Device Correction letter on March 23, 2011, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to include the Safety Advisory Notice in their LANTIS owner manual and contact there Siemens Service Engineer or Application Specialist or contact Lantis4.healthcare@siemens.com.
For questions regarding this recall 925-602-8157.
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
Infusor, pressure, for i.V. Bags - Product Code KZD
Causa
Infusable and infusascan pressure infusors may leak and not apply desired pressure to their iv solution bag and subsequently the rate of infusion may be inadequate.
Acción
The firm, GE Healthcare, sent an "URGENT MEDICAL DEVICE CORRECTION" letter dated February 25, 2011 with an attached return response form to its customers via Fed Ex. The letter describes the product, problem and actions to be taken. The customers were instructed to do the following:
1) DO NOT use infusable or InfusaScan pressure infusors (listed lot numbers).
2) Isolate all affected product and contact Vital Signs Customer Service at +1-973-956-5300 to arrange for the return and replacement of the infusor.
3) If they have forwarded any of the affected product to any other healthcare institution, forward a copy of this letter to those institutions.
4)Return only unused product.
In addition, the customers were instructed to ensure that all potential users in their facility were made aware of this safety notification and the recommended actions, and to complete and return the attached confirmation form via fax to +1-973-956-5440.
Please contact your local GE Healthcare Service Representative if you have any questions or concerns regarding this notification. You may also contact GE Healthcare Call Center: United States or Canada: 800-437-1171 and Other countries: 262-896-2890.
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, Cardiovascular - Product Code DTH
Causa
Mislabeled - a number of units of the product labeled as 4-0 black mono nylon suture product contain a 4-0 black braided silk suture.
Acción
Surgical Specialites sent an Urgent Product Recall Notification letter on March 30, 2011, along with an attached Customer Acknowledgment Form to the affected consignees. It was reported that upon opening a box labeled as 4.0 Black Mono Nylon, it was observed that the package acutally contained 4-0 Black Braided Silk suture.
Customers were to review their current inventory, segregate the affected lot number and / or contact their customer accounts that have purchased this specific item / lot code requesting a return of the product to customers' facility.
To ensure customers have received this notification and to arrange for credit and the return of identified product, the Customer Acknowledgment Form should be completed and returned via fax to our Quality Assurance department at (610) 404-8488.
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
Needle, hypodermic, single lumen - Product Code FMI
Causa
Incorrect unit package labels which reflect reorder #305216 instead of the correct item, reorder #305213, were used.
Acción
BD sent an Urgent: Product Recall letter with return response forms to direct consignees on 03/01/11 and 03/02/11 via UPS. The letter identified the affected product and lot along with the reason for the recall. The letter asked customers to complete the enclosed Distributor Packing List and to follow the instructions provided on the Packing List for returning the affected product. The firm will issue a credit upon receipt of the affected product. Customers can contact BD Customer Service if they need assistance or have 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.
A small number of oxygen mask components were found to have 100% obstructed airways rendering them incapable of delivering oxygen to patients undergoing respiration therapy.
Acción
The firm, Salter Labs, called all their customers on March 25, 2011 and asked that they hold all affected product. In addition, the firm sent an "URGENT PRODUCT RECALL" letter dated April 4, 2011 and a follow-up letter dated April 7, 2011 via e-mail and certified mail to all customers. The letter described the product, problem and actions to be taken. The customers were instructed to examine their inventory, return any affected lots listed, contact Salter Customer Service at 1-800-235-4203 to arrange for return of affected product and complete and return the Customer Reply Form via 661-854-6816 or toll free 1-800-628-4690.
Should you have any questions, please contact Salter Labs at 1-800-235-4203.
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
Mask, oxygen - Product Code BYG
Causa
A small number of oxygen mask components were found to have 100% obstructed airways rendering them incapable of delivering oxygen to patients undergoing respiration therapy.
Acción
The firm, Salter Labs, called all their customers on March 25, 2011 and asked that they hold all affected product. In addition, the firm sent an "URGENT PRODUCT RECALL" letter dated April 4, 2011 and a follow-up letter dated April 7, 2011 via e-mail and certified mail to all customers. The letter described the product, problem and actions to be taken. The customers were instructed to examine their inventory, return any affected lots listed, contact Salter Customer Service at 1-800-235-4203 to arrange for return of affected product and complete and return the Customer Reply Form via 661-854-6816 or toll free 1-800-628-4690.
Should you have any questions, please contact Salter Labs at 1-800-235-4203.
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
Mask, oxygen - Product Code BYG
Causa
A small number of oxygen mask components were found to have 100% obstructed airways rendering them incapable of delivering oxygen to patients undergoing respiration therapy.
Acción
The firm, Salter Labs, called all their customers on March 25, 2011 and asked that they hold all affected product. In addition, the firm sent an "URGENT PRODUCT RECALL" letter dated April 4, 2011 and a follow-up letter dated April 7, 2011 via e-mail and certified mail to all customers. The letter described the product, problem and actions to be taken. The customers were instructed to examine their inventory, return any affected lots listed, contact Salter Customer Service at 1-800-235-4203 to arrange for return of affected product and complete and return the Customer Reply Form via 661-854-6816 or toll free 1-800-628-4690.
Should you have any questions, please contact Salter Labs at 1-800-235-4203.
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
Mask, oxygen - Product Code BYG
Causa
A small number of oxygen mask components were found to have 100% obstructed airways rendering them incapable of delivering oxygen to patients undergoing respiration therapy.
Acción
The firm, Salter Labs, called all their customers on March 25, 2011 and asked that they hold all affected product. In addition, the firm sent an "URGENT PRODUCT RECALL" letter dated April 4, 2011 and a follow-up letter dated April 7, 2011 via e-mail and certified mail to all customers. The letter described the product, problem and actions to be taken. The customers were instructed to examine their inventory, return any affected lots listed, contact Salter Customer Service at 1-800-235-4203 to arrange for return of affected product and complete and return the Customer Reply Form via 661-854-6816 or toll free 1-800-628-4690.
Should you have any questions, please contact Salter Labs at 1-800-235-4203.
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 small number of oxygen mask components were found to have 100% obstructed airways rendering them incapable of delivering oxygen to patients undergoing respiration therapy.
Acción
The firm, Salter Labs, called all their customers on March 25, 2011 and asked that they hold all affected product. In addition, the firm sent an "URGENT PRODUCT RECALL" letter dated April 4, 2011 and a follow-up letter dated April 7, 2011 via e-mail and certified mail to all customers. The letter described the product, problem and actions to be taken. The customers were instructed to examine their inventory, return any affected lots listed, contact Salter Customer Service at 1-800-235-4203 to arrange for return of affected product and complete and return the Customer Reply Form via 661-854-6816 or toll free 1-800-628-4690.
Should you have any questions, please contact Salter Labs at 1-800-235-4203.
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.
Accolade tmzf plus hip stems are being recalled due to grit blast media which was observed in the drive hole.
Acción
Stryker Orthopaedics sent an Urgent Product Recall letter dated March 1, 2011, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to fax back the attached Product Recall Acknowledgement Form within 5 days to 201-831-6069.
Customers were also instructed to:
Contact the hospitals in their territory that have the affected product to arrange return of the product.
Return the affected product via and Inter-Org Transfer to the attention of Regulatory Compliance, Stryker Orthopaedics, 325 Corporate Drive, Mahwah, New Jersey 07430.
Attach the fluorescent orange PRODUCT REMEDIATION sticker to their return, indicating the Product Remediation # RA 2009-459. Mark the outer box with the words "Product Recall."
For any questions call (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
Orthopedic Screwdriver - Product Code HXX
Causa
This recall has been initiated due to drivers that may contain a burr in the distal tip preventing full seating of the driver onto the head of the facet screw, resulting in difficulty screwing the facet screw into the bone.
use of this product may result in a delay of the surgical procedure.
Acción
Interventional Spine, Inc. sent an "Urgent Recall" letter dated March 15, 2011 to all affected customers.
The letter included; affected product, reason for recall and recommendations.
Customers were asked to immediately examine inventory, quarantine affected product and to notify International Spine, Inc if any product remain.
For information on this recall contact the firm at (949) 472-0006.
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
Orthopedic Screwdriver - Product Code HXX
Causa
This recall has been initiated due to drivers that may contain a burr in the distal tip preventing full seating of the driver onto the head of the facet screw, resulting in difficulty screwing the facet screw into the bone.
use of this product may result in a delay of the surgical procedure.
Acción
Interventional Spine, Inc. sent an "Urgent Recall" letter dated March 15, 2011 to all affected customers.
The letter included; affected product, reason for recall and recommendations.
Customers were asked to immediately examine inventory, quarantine affected product and to notify International Spine, Inc if any product remain.
For information on this recall contact the firm at (949) 472-0006.
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
Orthopedic Screwdriver - Product Code HXX
Causa
This recall has been initiated due to drivers that may contain a burr in the distal tip preventing full seating of the driver onto the head of the facet screw, resulting in difficulty screwing the facet screw into the bone.
use of this product may result in a delay of the surgical procedure.
Acción
Interventional Spine, Inc. sent an "Urgent Recall" letter dated March 15, 2011 to all affected customers.
The letter included; affected product, reason for recall and recommendations.
Customers were asked to immediately examine inventory, quarantine affected product and to notify International Spine, Inc if any product remain.
For information on this recall contact the firm at (949) 472-0006.
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
Passer, wire, orthopedic - Product Code HXI
Causa
This recall has been initiated due to k-wires with a distal tip diameter that may be greater than specified causing an interference fit with the canulated screw. removing the k-wire during a procedure may dislocate the implant resulting in the implant loosening or being pulled out or position.
use of this product may result in a delay of the surgical procedure and/or pull-out of the facet screw.
Acción
Interventional Spine sent an RECALL NOTIFICATION letter dated March 23, 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 to take the following actions: Immediately examine inventory and quarantine product subject to recall. In addition, if this product was further distributed, please notify the Vice President Quality Assurance at once.
Consignee were asked to also complete and return the enclosed response form as soon as possible. Consignee with questions were directed to the Consignees' Regional Director or the Vice President Quality Assurance.
For further questions, please call (949) 472-0006
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
Passer, wire, orthopedic - Product Code HXI
Causa
This recall has been initiated due to k-wires with a distal tip diameter that may be greater than specified causing an interference fit with the canulated screw. removing the k-wire during a procedure may dislocate the implant resulting in the implant loosening or being pulled out or position.
use of this product may result in a delay of the surgical procedure and/or pull-out of the facet screw.
Acción
Interventional Spine sent an RECALL NOTIFICATION letter dated March 23, 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 to take the following actions: Immediately examine inventory and quarantine product subject to recall. In addition, if this product was further distributed, please notify the Vice President Quality Assurance at once.
Consignee were asked to also complete and return the enclosed response form as soon as possible. Consignee with questions were directed to the Consignees' Regional Director or the Vice President Quality Assurance.
For further questions, please call (949) 472-0006
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
Bed, patient rotation, powered - Product Code IKZ
Causa
Buckles used to secure patient to surface during proning therapy can come open if not properly engaged by user.
Acción
Firm sent a letter with the "Warning: Improper Insertion of the RotoProne Therapy System Buckle Can Lead To Unintentional Bed Exit" to all consignees on 2/23/2011. The letter identified the affected product and the reason for the recall. Customers were instructed to read the attached product warning regarding the proper method to attach the RotoProne buckles and to post it with the device to ensure continued proper use of the buckles. If customers had questions regarding the proper use of the buckles, they were to contact KCI Customer Technical Service at 1-800-275-4524.
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.
This recall has been initiated due to pull pins that may disengage from the facet screw during the compression step, requiring that compression be completed with a device driver rather than the compression tool.
use of this product may result in less than optimal compression leading to pseudoarthrosis, non-union or facet pain.
Acción
Interventional Spine, Inc. sent a recall letter dated March 15, 2011, informing consignees of the product, the problem, and the action to be taken. Consignees were asked to immediately examine their inventory and quarantine product subject to recall. In addition, if they distributed the product further they were asked to notify Jane Metcalf, the Vice President of Quality Assurance at once.
Interventional Spine further informed consignees that the recall was being carried out to the individual consignee level. And their assistance was appreciated and necessary to prevent use of this product.
They were then asked to complete and return the enclosed response form as soon as possible. Questions were directed to call their regional directors.
For questions regarding this recall call 949-472-0006.
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
radiotherapy delivery system - Product Code IYE
Causa
An improperly installed collimator cover may detach and fall from the machine, potentially striking the patient or nearby personnel.
Acción
On 3/17/2011, Varian Medical Systems sent an Urgent Medical Device Correction Letter to all affected users, with a description of the problem and user corrective action steps.
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
Dispenser, cement - Product Code KIH
Causa
Recalling firm has discovered through internal testing that the cortoss(tm) delivery gun may abrade its packaging material under certain transportation and handling conditions. this abrasion may cause small holes or tears in the packaging material, which may not be immediately visible to the user. although t the cortoss(tm) delivery gun is provided in double pouches and there have been no report.
Acción
Orthovita sent an "URGENT FIELD SAFETY NOTICE" letter dated March 31, 2011 to all customers. The letter described the product, problem and actions to be taken. The customers were instructed to Identify, quarantine and discontinue use of the affected product. The letter included an acknowledgement form to be completed and returned as per instructions.. The letter states that the recalling firm will contact customers to arrange for the return or destruction of any affected product. A pre-paid shipping label is provided for product return. The letter also states that the recalling firm will provide replacement product at no cost.
For any questions regarding this notice call 484-323-8860.