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 hx2 temperature management system mixing valve may fail resulting in an unusable water channel and then the machine would go into standby mode.
Acción
The firm, TERUMO Cardiovascular Systems, sent an "URGENT MEDICAL DEVICE CORRECTION" letter dated June 11, 2010, to the consignees. The letter describes the product, reason for correction, what to do in the event of failure, potential hazard, correction, affected population and action to be taken by the customers. The customers are instructed to review the correction notice, assure that all users are aware of this notice, and complete, sign and fax the attached Customer Response Form to Terumo CVS Customer Service at 800-292-6551. The Terumo CVS Customer Service Dept. will contact you upon receipt of the Customer Response Form to schedule the replacement. The firm plans to inspect and correct all units in the field within 5 months.
We encourage you to contact Terumo CVS Customer Service at 1-800-521-2818, Monday-Friday, 8 AM-6 PM EST, with any questions or concerns.
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
Reaction Vessels - Product Code JJE
Causa
Vessel pick up errors and vessel jams when the vessel is being loaded. the error halts the instrument and disrupts processing. vessel flange is thin.
Acción
Siemens Healthcare Diagnostics issued an Urgent Field Safety Notice dated March 2010 informing users of the potential problem, to discard any remaining product, and if needed, to request a replacement lot.
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
Radioimmunoassay, cortisol - Product Code CGR
Causa
The recall was initiated because beckman coulter has confirmed that the listed lot numbers of active control elisa reagent will result in falsely high values for patient samples due to a shift in the calibration of the assigned standard values.
beckman coulter recommends that patient results, generated with the affected lots, be evaluated in the context of other diagnostic tests and the clinica.
Acción
Beckman Coulter sent a Product Corrective Action (PCA) letter dated July 13, 2009. The letter identified the product, the problem, and the action to be taken by the customer.
Customers were instructed to discontinue use until further notice and discard remaining affected product. Customers were instructed to contact Beckman Coulter at 1-800-231-7970.
Newer lots (lot number 991069 or higher) of the product have been recalibrated to restore the performance as described in the Instructions for Use (IFU). For method correlation information, please contact Technical Support at the phone number listed below.
Consignees were asked to share this information with laboratory staff and retain the PCA letter for their Quality System documentation, and complete and return the enclosed Response Form within 10 days so that the firm can be assured that they received the notification.
Questions regarding this notification were directed to the DSL Technical Support Center at 1-800-231-7970 in the United State and Canada, or their local Beckman Coulter Representative.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notas adicionales en la data
Gauze/sponge, internal, x-ray detectable - Product Code GDY
Causa
There are 1-2 places on some of the multi-purpose kit blisters/trays in which there are holes and/or the material is so thin that holes are easily created. this would potentially cause the sterility of the products to be compromised.
Acción
Argon Medical Devices issued an "Urgent Medical Device Recall" notification via certified mail dated March 29, 2010 to distributors and end users. A Response Form was attached. Consignees were informed of the affected product and asked to quarantine and return all unused product to the firm.
For further information, contact Argon Medical Devices at 1-903-677-9375.
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
surgical microscope footswitch - Product Code FSO
Causa
The pedals of the footswitch type b stick and the zoom/focus moves to the end position.
Acción
Leica Microsystems sent Medical Device Correction letters dated 3/29/10 to the affected customers via first class mail on the same date, informing them of the potential for injury to the patient's eye if the cross pedal of the footswitch sticks. They were informed that their local Leica Microsystems representative will contact them to arrange for the replacement of the cross pedal. The letters also provided the interim necessary steps required to avoid the risk of patient injury while they are awaiting the cross pedal replacement, i.e. do not use the affected footswitches with a surgical microscope that has a BIOM accessory. The accounts were requested to complete the attached Acknowledgement Form, listing the serial numbers of the units at their facility and fax it back to Leica at 1-847-607-3147. A company contact was provided in the letter for questions.
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
Gauze/sponge, internal, x-ray detectable - Product Code GDY
Causa
There are 1-2 places on some of the multi-purpose kit blisters/trays in which there are holes and/or the material is so thin that holes are easily created. this would potentially cause the sterility of the products to be compromised.
Acción
Argon Medical Devices issued an "Urgent Medical Device Recall" notification via certified mail dated March 29, 2010 to distributors and end users. A Response Form was attached. Consignees were informed of the affected product and asked to quarantine and return all unused product to the firm.
For further information, contact Argon Medical Devices at 1-903-677-9375.
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
Inability to properly align the calcaneal screw placement on a consistent basis, due to a manufacturing defect of of the targeting frame (panta support device).
Acción
OIntegra issued Urgent Product Recall Notification letters dated 3/1/2010 to customers and distributors to notify them of the problem. Customers were requested to check their inventory to determine if they have an of the affected devices. If so, custo0mers should stop using the product. Custoemrs with the affected product should contact their local Sales Representative for assistance, or contact Integra at 800-654-2873 - 3 to obtain a returned material authorization number, and return the product to their local representative.
All customers were requested to complete and return a Recall Acknowledgement and Return 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
Screw, fixation, bone - Product Code HWC
Causa
On 3/9/10 it was discovered that the recalling firm packaged mft-021-35-24 screws from lot 0964092 as mft-021-35-22 lot 0964081.
Acción
OrthoHelix Surgical Designs, Inc. issued an "Important Field Correction Notice" dated March 23, 2010 via FedEx overnight. They instructed their customers to inventory their stock for affected product. All affected product will be replaced by the firm.
For further information, contact OrthoHelix Surgical Designs, Inc. at 1-330-247-1444.
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
Analyzer, chemistry (photometric, discrete), for clinical use - Product Code JJE
Causa
The recall was initiated because the wash concentrate tube assembly 142 may fail to deliver the appropriate amount of wash concentrate on some synchron dxc systems due to an accumulation of crystals.
the impact of this issue would include:
(1) quality control and patient results can potentially be affected.
(2) if system has been calibrating properly and quality control is recovering within es.
Acción
Beckman Coulter sent out an "Urgent Product Corrective Action" letter dated July 23, 2009 and mailed the week of July 27, 2009 to all affected customers. The letter provides the cusotmers with explanation of the problem identifed and asks them to take the following actions:
" If consignees are not able to resolve these issues through routine troubleshooting they were told to contact BCI Customer Technical Support at (800) 854-3633 in the United States and Canada.
" This issue will be corrected with an upcoming software version and tubing modification.
" Complete and return the enclosed response form within 10 days so that Beckman Coulter may maintain their records.
Consignees were also asked to share this information with their laboratory staff and retain this notification as part of their laboratory Quality System documentation.
Questions regarding this Product Corrective Action letter were directed to their Customer Technical Support Center (Hotline) at (800) 854-3633 in the United States and Canada.
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.
Anomaly 1, invalid characters in patient id error:
currently, odyssey considers a valid id to be comprised of numbers and/or letters. if a patient id in a study contains a character other than a letter or number (including spaces). odyssey removes the invalid character when moving it to a patient folder. due to this, it is possible that two different patient studies could be listed within odyssey.
Acción
A letter dated March 23, 2010 was mailed to customers acknowledging the anomalies and informed the reader that the mandatory version correcting the software will be provided by May 19, 2010. Customers with version 4.4 will receive 4.4.04:t hose with version 4.5 will receive 4.5.04; and those with version 4.6 will receive 4.6.01 containing the corrections to these issues. In the meantime, the following recommendations are provided. For Anomaly I . Invalid Characters in Patient ID Error, it 1s recommended that the users do not create patient IDS that contain characters other than letters or numbers. For Anomaly 2.0dysse.v Muchitle Library Collimator Type Error, it is recommended that the customer contact PerMedics ifany modifications to the library have been performed. The primary view should also be examined and used to detect and avoid the conditions causing the anomaly. Finally, independent field shape and monitor unit checks should be performed as part of a routine quality assurance program. For Anomaly 3, OOdyssey MLC Block Error, it is recommended to avoid using the MLC Block feature until the mandatory version correcting this anomaly is installed. If you need to use this feature, then it is recommended that a physical block tray is used during treatment for each beam that contains an Odyssey MLC Block.
If customers believe a patient treatment has been affected by any of these issues, they should notify Customer Support as soon as possible at 877-4PerMed (877-473-7633) or support@permedics.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
Chair, dental, with operative unit - Product Code KLC
Causa
Magnetic headrests may affect patients with implantable pacemakers and defibrillators.
Acción
Pelton & Crane Issued an "Urgent Field Safety Alert" notification dated February 24, 2010. Consignees were instructed of the affected product and informed of proper actions to take.
For further information, contact Pelton & Crane at 1-704-588-2126.
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
Chair, dental, with operative unit - Product Code KLC
Causa
Magnetic headrests may affect patients with implantable pacemakers and defibrillators.
Acción
Pelton & Crane Issued an "Urgent Field Safety Alert" notification dated February 24, 2010. Consignees were instructed of the affected product and informed of proper actions to take.
For further information, contact Pelton & Crane at 1-704-588-2126.
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
Chair, dental, with operative unit - Product Code KLC
Causa
Magnetic headrests may affect patients with implantable pacemakers and defibrillators.
Acción
Pelton & Crane Issued an "Urgent Field Safety Alert" notification dated February 24, 2010. Consignees were instructed of the affected product and informed of proper actions to take.
For further information, contact Pelton & Crane at 1-704-588-2126.
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.
Fixation thumbscrew on the dbs depth stop adapter may be overtightened and damage the implantable lead.
Acción
FHC issued an "URGENT: MEDICAL DEVICE CORRECTION" letter dated March 29, 2010, to all customers. The letter described the product, problem and actions to be taken by the customers. FHC informed the customers that that they had returned to the original design of the fixation screw in the Depth Stop Adapter. FHC sent replacement Depth Stop Adapter with an original fixation screw. The customers were instructed to discard the recalled Depth Stop Adapter (s) and replace with the enclosed corrected version(s) and sign and fax the receipt notification to 207-666-8309 as proof of their receipt of notification. For assistance with the product replacement, contact the FHC's technical support line at 800-326-2905. This line is staffed 24 hours a day.
Should you have any further questions regarding this matter, please contact Dorothee Sasse, product manager, or Keri Seitz, recall coordinator at 207-666-8190.
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.
Fixation thumbscrew on the dbs depth stop adapter
may be overtightened and damage the implantable lead.
Acción
FHC issued an "URGENT: MEDICAL DEVICE CORRECTION" letter dated March 29, 2010, to all customers. The letter described the product, problem and actions to be taken by the customers. FHC informed the customers that that they had returned to the original design of the fixation screw in the Depth Stop Adapter. FHC sent replacement Depth Stop Adapter with an original fixation screw. The customers were instructed to discard the recalled Depth Stop Adapter (s) and replace with the enclosed corrected version(s) and sign and fax the receipt notification to 207-666-8309 as proof of their receipt of notification. For assistance with the product replacement, contact the FHC's technical support line at 800-326-2905. This line is staffed 24 hours a day.
Should you have any further questions regarding this matter, please contact Dorothee Sasse, product manager, or Keri Seitz, recall coordinator at 207-666-8190.
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
in vitro diagnostic - Product Code LKJ
Causa
Inaccurate results-- consumer complaints of increased positivity rates with the ana screening kit.
Acción
Recall was initiated on 3/1/2010. DiaSorin S.R.I. (the sole consignee) was alerted via email using the firm's Medical Device Recall Notification. Consignee informed of the recall and instructed to dispose of the affected product according to local laws.
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.
Some viromax viral/bacterial filters are leaking at the point where the two halves of the filter are ultrasonically bonded together.
Acción
A - M Systems sent a Urgent Notification of Product Recall/Correction dated March 31, 2010, to all affected customers. The letter identificed the product the problem and the action needed to be taken by the customer.
Customers were instructed to cease use and/or distribution of the affected product and to immediately notify any of their sub-accounts with the same information. Customers are asked to provide A - M Systems with the amount distributed and amount remaining in inventory and to then destroy or discard any remaining product in their possession.
Please call 360.683.8300, if you have any questions or concerns.
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 received complaints regarding the siderails not operating correctly or becoming inoperable. the siderails could experience false latching, unintentional lowering or become inoperable. there have been reports of 5 patient falls and 2 injuries to caregivers.
Acción
Hill-Rom sent out "Urgent Medical Device Correction" letters dated March 5, 2010. The letters described the product, problem and actions to be taken by the customers. The letters instructed the customers to locate the beds and examine the siderails for any visible damage (cracks, bending, loose parts) and conduct a physical assessment of all four siderails on each bed to determine if the sideral could be placed in all positions. If the siderails were found to be inoperable, the bed was to be taken out of service until a qualified Hill-Rom technician can make any necessary correction. The customers were instructed to contact Hill-Rom to make arrangements and inform them of all beds that they have loaned, sold, no longer use or disposed of at 800-445-3720, option 2. The letter states the firm is evaluating a design change to the siderail.
If you have any questions concerning this request or the procedure as outlined, please contact Hill-Rom Technical Support at 800-445-3720, option 2.
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 received complaints regarding the siderails not operating correctly or becoming inoperable. the siderails could experience false latching, unintentional lowering or become inoperable. there have been reports of 5 patient falls and 2 injuries to caregivers.
Acción
Hill-Rom sent out "Urgent Medical Device Correction" letters dated March 5, 2010. The letters described the product, problem and actions to be taken by the customers. The letters instructed the customers to locate the beds and examine the siderails for any visible damage (cracks, bending, loose parts) and conduct a physical assessment of all four siderails on each bed to determine if the sideral could be placed in all positions. If the siderails were found to be inoperable, the bed was to be taken out of service until a qualified Hill-Rom technician can make any necessary correction. The customers were instructed to contact Hill-Rom to make arrangements and inform them of all beds that they have loaned, sold, no longer use or disposed of at 800-445-3720, option 2. The letter states the firm is evaluating a design change to the siderail.
If you have any questions concerning this request or the procedure as outlined, please contact Hill-Rom Technical Support at 800-445-3720, option 2.
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
photopheresis kit - Product Code LNR
Causa
Higher than normal blood leaks on therakos cellex procedural kits that are intended for use with the therakos cellex photopheresis system.
Acción
On March 29, 2010, Therakos Photopheresis sent Important Product Correction Notification letters by FedEx to all direct end use and distributor customers who received lot X120 in addition to phone contact. On March 31, 2010 those who received lot X123 were sent letters by Fed Ex as well as phone contact.. The one Canadian customer was notified by phone on March 31, 2010 followed by a Fed Ex letter. On April 12, consignees who were shipped Lot X119 were contacted by phone, followed by a hard copy letter.
On May 7, 2010 all direct end use and distributor consignees were notified of the additional lot being added to the recall.
Questions may be directed to Therakos Customer Technical Services at 1-877-865-6850.
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, biliary, diagnostic - Product Code FGE
Causa
Ev3 is conducting a voluntary recall on three lots of the prot¿g¿ everflex" biliary stent system. they determined that a lot of 120mm prot¿g¿ everflex" biliary stent system may contain a 150mm length self-expanding stent and two lots o 150mm prot¿g¿ everflex" biliary stent system may contain a 120 mm length self-expanding stent.
Acción
ev3 issued "Medical Device Recall" notifications dated March 31, 2010 addressed to "Dear Risk Manager or Cath Lab Manager". Each letter addressed the affected product. Users were instructed to locate and remove from use the affected product and a sales representative will be in contact shortly to arrange for return.
For further information, contact ev3 Customer Service at 1-800-716-6700.
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
Dilator, vessel, for percutaneous catheterization - Product Code DRE
Causa
There are 1-2 places on some of the multi-purpose kit blisters/trays in which there are holes and/or the material is so thin that holes are easily created. this would potentially cause the sterility of the products to be compromised.
Acción
Argon Medical Devices issued an "Urgent Medical Device Recall" notification via certified mail dated March 29, 2010 to distributors and end users. A Response Form was attached. Consignees were informed of the affected product and asked to quarantine and return all unused product to the firm.
For further information, contact Argon Medical Devices at 1-903-677-9375.
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, gastro-enterostomy - Product Code KGC
Causa
There are 1-2 places on some of the multi-purpose kit blisters/trays in which there are holes and/or the material is so thin that holes are easily created. this would potentially cause the sterility of the products to be compromised.
Acción
Argon Medical Devices issued an "Urgent Medical Device Recall" notification via certified mail dated March 29, 2010 to distributors and end users. A Response Form was attached. Consignees were informed of the affected product and asked to quarantine and return all unused product to the firm.
For further information, contact Argon Medical Devices at 1-903-677-9375.
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, gastro-enterostomy - Product Code KGC
Causa
There are 1-2 places on some of the multi-purpose kit blisters/trays in which there are holes and/or the material is so thin that holes are easily created. this would potentially cause the sterility of the products to be compromised.
Acción
Argon Medical Devices issued an "Urgent Medical Device Recall" notification via certified mail dated March 29, 2010 to distributors and end users. A Response Form was attached. Consignees were informed of the affected product and asked to quarantine and return all unused product to the firm.
For further information, contact Argon Medical Devices at 1-903-677-9375.
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, gastro-enterostomy - Product Code KGC
Causa
There are 1-2 places on some of the multi-purpose kit blisters/trays in which there are holes and/or the material is so thin that holes are easily created. this would potentially cause the sterility of the products to be compromised.
Acción
Argon Medical Devices issued an "Urgent Medical Device Recall" notification via certified mail dated March 29, 2010 to distributors and end users. A Response Form was attached. Consignees were informed of the affected product and asked to quarantine and return all unused product to the firm.
For further information, contact Argon Medical Devices at 1-903-677-9375.