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.
Volume control knob not able to go up to larger diameters.
Acción
A letter was issued to the sales representative that have customers which received affected product, 5/24/2006. Sales representatives visited their sites within 3 days to determine if the affected product was still in inventory. If the product was still in inventory the sales representative provided the trained TriActiv System user(s) a Technical Bulletin that instructed the users how to correct the knob position.
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
wheelchair seat - Product Code ITI
Causa
Some of the wheelchairs were distributed with seats that did not have a seat positioning strap.
Acción
The recalling firm sent a recall letter, dated 06/06 to consignees.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notas adicionales en la data
Defibrillator - Product Code MJK
Causa
The welch allyn pic 50 defibrillators may display a 'defib comm' or 'pace comm' error message on the device display during use which may result in a terminal failure of the device to analyze the patient's ecg and deliver the appropriate therapy.
Acción
MRL sent Urgent Medical Device Recall letters dated 6/30/06 via certified mail to the direct accounts informing them of an intermittent connection between a pin and socket on a circuit board inside of the device that could result in a malfunction that prevents or unacceptably delays the delivery of a defibrillating shock, which possibly could result in failure to resuscitate the patient. The accounts were provided a list of the affected units' parts/serial numbers and requested to inspect their PIC 50 units for the affected serial numbers and return the identified units for servicing. The accounts were also instructed to respond to the notification within 5 working days if the unit has displayed the Defib Comm error, and within 30 days if it has not displayed the Defib Comm error by fax or mail. A loaner PIC 50 will then be sent to the consignee with instructions on how to return their unit for correction.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notas adicionales en la data
radiation therapy - Product Code JAQ
Causa
Medical device software for brachytherapy may cause erroneous data to be recorded and affect patient radiation treatments. erroneous data may be listed on the treatment history report, and the default step size may lead to a misadministration if treatment data is entered manually.
Acción
The recalling firm notified end users by letter on 05/01/06 and advised users of possible communication error between afterloader devices and software. The notification also advised that the control program for the devices has the potential to lead to a misadministration of treatment in cases where data is manually entered by the user. The firm additionally advised that user may continue to use the afterloader devices if following the listed cautionary statements. A software upgrade is planned to be implemented at the user site''s next regularly scheduled radiation source exchange. A response form is enclosed with the notification and users are requested to return the customer receipt verification via fax.
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
waste tubing - Product Code CHL
Causa
An increased failure rate was observed with the yellow rubber tubing. the tubing was found to be leaking blood and solutions after distribution.
Acción
The recalling firm issued a letter to their customers dated 5/22/2006. The letter informs the customer(s) of the tubing defect and provides the customer with one (1) tubing to deal with any immediate needs which they may have. Should the customer require additional waste pump tubing replacements, the letter is accompanied by a FAX FORM which can be used to request any amount of additional replacement tubing required. The letter also shows tthe address to which the replacement tubing is to be delivered, and provides a Purchase Order request to be used, if required.
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
blood gas analyzer - Product Code CHL
Causa
Air bubbles may be trapped on or close to the o2 sensor in the po2 chamber of the cuvettes in cartridges used for blood gas analysis on npt7 analyzer. this produces too high po2 readings without a question mark.
Acción
The recalling firm initiated this recall with a letter to send to their customers, via Registered Mail, on 5/1/2006. The letter requests that the customers identify and discard the potentially defective cartridges from Lot #R0299. The letter is accompanied by a recall response page to be completed by the customer and faxed or mailed back to the Radiometer so that the customer can receive an equal number of replacement cartridges free-of-charge.
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
diagnostic test results report software - Product Code JQP
Causa
Software anomaly. data generated by blood gas equipment did not correlate with data shown in the radiance data management system.
Acción
The firm initiated this recall with letters to their customers on 3/2/2005. After this notification, the firm''s Field Service Reps visited each affected customer and updated their software to version 2.42. According to the firm, these actions took place from 3/12/2005 thru 4/15/2005. The Field Reps. of Radiometer America reported to Radiometer Medical ApS in Denmark that the necessary corrections had been competed as of: 4/15/2005.
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
Cutaneous Oxygen Monitor - Product Code KLK
Causa
Alarm may be silenced- rapid switching, on and off, of the tcm4 monitor may cause the built-in acoustical alarm to remain silent when tripped.
Acción
The firm initiated a recall action for the suspect device with a letter dated 2/2/2005. During a site visit to the U.S. customers conducted by the firm''s Field Service reps, the reps informed the user/customers of this problem and requested that all use of the device be discontinued, pending the formulation of a more permanent solution. Beginning on 2/8/2005, a second site visit was made to the same user/customers, at which time, the affected units were upgraded with operating software version 2.12. The firm''s recall/corrective action was scheduled for completion by 3/1/2005.
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
UF Removal Regulators - Product Code KDI
Causa
The uf removal regulators were assembled incorrectly. the mis-assembly results in a failure to successfully calibrate the instrument and begin patient therapy.
Acción
Baxter sent Urgent Device Correction letters dated 06/21/06 to all System 1000, TINA, Altratouch, Arena and Aurora Hemodialysis Instrument customers who may have received the nonconforming assemblies via first class mail on the same date, to the attention of the Hemodialysis Administrator. The letters informed the accounts that the three lots of UF Removal Regulators were potentially assembled incorrectly. While these regulators are identical in appearance to properly assembled components, the mis-assembly results in a failure to successfully calibrate the instrument and begin patient therapy. Replacement regulators were included with the recall letter, and the accounts were requested to return the regulators from their previous shipment to Baxter using the enclosed mailing materials. The accounts were requested to complete the enclosed reply form indicating the number of units received and the number of units returned and acknowledging receipt of the letter and dissemination of the information to their staff and to other services of facilities, as applicable, and fax the sheet to 1-727-544-3025. Any technical questions were directed to Baxter Global Technical Services at 1-800-553-6898, prompt 3, option 2, choice 1.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notas adicionales en la data
radiation therapy - Product Code JAQ
Causa
Medical device software for brachytherapy may cause erroneous data to be recorded and affect patient radiation treatments. erroneous data may be listed on the treatment history report, and the default step size may lead to a misadministration if treatment data is entered manually.
Acción
The recalling firm notified end users by letter on 05/01/06 and advised users of possible communication error between afterloader devices and software. The notification also advised that the control program for the devices has the potential to lead to a misadministration of treatment in cases where data is manually entered by the user. The firm additionally advised that user may continue to use the afterloader devices if following the listed cautionary statements. A software upgrade is planned to be implemented at the user site''s next regularly scheduled radiation source exchange. A response form is enclosed with the notification and users are requested to return the customer receipt verification via fax.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notas adicionales en la data
radiation therapy - Product Code JAQ
Causa
Medical device software for brachytherapy may cause erroneous data to be recorded and affect patient radiation treatments. erroneous data may be listed on the treatment history report, and the default step size may lead to a misadministration if treatment data is entered manually.
Acción
The recalling firm notified end users by letter on 05/01/06 and advised users of possible communication error between afterloader devices and software. The notification also advised that the control program for the devices has the potential to lead to a misadministration of treatment in cases where data is manually entered by the user. The firm additionally advised that user may continue to use the afterloader devices if following the listed cautionary statements. A software upgrade is planned to be implemented at the user site''s next regularly scheduled radiation source exchange. A response form is enclosed with the notification and users are requested to return the customer receipt verification via fax.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notas adicionales en la data
radiation treatment system - Product Code JAQ
Causa
Software control program for a medical device used in radiation treatment may cause practitioners to incorrectly administer the treatment plan to cancer patients. there is a hazard when entering the treatment plans manually that the user neglects to change the default step size and/or the origin or accidentally enters incorrect parameters.
Acción
The recalling firm notified healthcare practitioners using the medical device by letter on 4/17/06 and continuing through 5/1/06. The notification was flagged as a 'Medical Device Recall' and instructed users to adjust system parameters in the autoexec.bat file. The notification further recommended using the identified treatment plans and that manual input should be used for QA purposes only.
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
automated hematology analyzer - Product Code GKZ
Causa
Labels can be incorrectly placed on a sample tube resulting in a possible error in results attributed to a sample.
Acción
Notifications have been prepared advising that following an occurrence observed outside of the United States, HORIBAABX is providing information regarding the rare circumstance of a label being incorrectly placed on a sample tube, resulting in a possible error in results attributed to a sample. The March 24, 2006, letter identifies various conditions in which the anomaly occurs.
In order to prevent this type of incident, the firm recommends that the customer ensure that the identification label is firmly attached to the sample tubes during their positioning or removal from the racks.
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
Dialyzer, High Permeability With Or Without Sealed Dialysate System - Product Code KDI
Causa
The hemodialysis device was being marketed with a modified treatment length that exceeds the treatment length for which the device was originally designed.
Acción
Aksys sent a Clinical Bulletin: Field Correction Recall, CB Number: 048, dated 6/26/2006, via overnight Federal Express to all clinics or patients currently using the PHD instrument. CB #048 advises patients that until field modifications to the PHD System can be performed to limit the maximum treatment time to 170 minutes, Aksys recommends that users not exceed this treatment time in the interim. Each user was requested to contact his/her clinic to discuss how this change may affect treatment options and to complete and mail an enclosed pre-paid, self-addressed receipt acknowledgement card.
A revised PHD System Operatror''s Manual was issued to all PHD System users on 7/12/06, which reflects the reduction in the maximum treatment time.
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
Staple, Fixation, Bone - Product Code JDR
Causa
The packages are labeled sterile, but the product was not sterilized.
Acción
Consignees were notified by letters dated 6/2/06 and sent via Federal Express and requesting return of the products.
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
Staple, Fixation, Bone - Product Code JDR
Causa
The packages are labeled sterile, but the product was not sterilized.
Acción
Consignees were notified by letters dated 6/2/06 and sent via Federal Express and requesting return of the products.
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
Machine may produce unexpected motions from the couch, collimator, and gantry rotation at maximum speeds.
Acción
The firm has initiated recall by sending its consignees a product notification letter 06/06/2006, and intends to dispatch service representatives to perform necessary modifications.
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
blood glucose test strips; - Product Code LFR
Causa
The drying agent beads, located in the cap, may become loose and fall into the vial causing the test strips to potentially give incorrect blood glucose test results.
Acción
U.S. consignees, point of care coordinators or laboratory managers, long term care professionals, health care professionals, pharmacists, and mail order distributors were notified via letter dated 6/28/06 to cease using the strips and to contact the firm for replacement if they see loose beads in their vial. International accounts were also notified.
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
blood glucose test strips; - Product Code LFR
Causa
The drying agent beads, located in the cap, may become loose and fall into the vial causing the test strips to potentially give incorrect blood glucose test results.
Acción
U.S. consignees, point of care coordinators or laboratory managers, long term care professionals, health care professionals, pharmacists, and mail order distributors were notified via letter dated 6/28/06 to cease using the strips and to contact the firm for replacement if they see loose beads in their vial. International accounts were also notified.
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
Ultrasonic instrument cleaner - Product Code FLG
Causa
Smoke, sparking and fire hazard-units manufactured between november 2000 and january 2005 are susceptible to water damage at the lid switch cable wiring harness, which may result in smoking, sparking, and fire.
Acción
The firm sent out a certified letter to all affected consignees alerting them to problems with the device on 6/22/06.
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
Chemistry Analyzer - Product Code NDW
Causa
Incorrect reagent status-when a new cartridge of infinity lithium reagent is loaded on to the unicel dxc system, the reagent status screen will incorrectly show 'days left' as 21. the correct reagent status for a new lithium reagent cartridge is 14 days. lithium reagent used past 14 days may produce low quality control and/or patient results.
Acción
A Product Correction Action (PCA) letter was sent the week of May 15, 2006 to all Unicel DxC customers informing them not to leave any Lithium reagent cartridge onboard a UniCel DxC System past 14 days. They also were instructed to complete and return the enclosed response form. The Letter was sent by US Mail.
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
table - Product Code JAI
Causa
During exactrac robotics installation on the varian exact couch, the couch height position indication is re-calibrated to read out the correct positions. this re-calibration could cause the eventual failure of the vertical lift mechanism of the couch, which might result in patient injury or death.
Acción
BrainLab issued a Product Notification Letter to the hospitals on 6/2/06 to advise the users not to lower the couch below 50 cm, and sent a second letter to the users on 6/7/06, informing them that BrainLab would remove the ExacTrac Robotics from the Exact Couch and re-calibrate the couch to restore the software limit switch. The Robotics will be re-installed once a permanent solution is available.
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
Cryo surgical clamp - Product Code GEH
Causa
Incorrect expiration date: three lots of the frostbyte (tm) clamp packaged with surgifrost 7 cm cryosurgical probes have incorrect expiration dates. these lots are labeled with a two (2) year expiratation date while the correct date is one (1) year.
Acción
Consignee''s were notified by ATS Medical Representatives via visits. Product was either relabeled with correct expiration date or retrieved by ATS Medical representatives.
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 tip of the catheter may separate from the body during operation.
Acción
The firm sent a letter in June 2006 to its consignees advising them that all impacted lots of Infiniti 6 French catheters (product codes attached) manufactured on Line #1 from July 2005 through February 2006 are being recalled, starting June 26, 2006. The U.S. initial consignee is being contacted directly by Cordis sales reps and other Cordis representatives. The initial consignee is being requested to sign an Acknowledgement Form. The Cordis representative is collecting any units at the consignee, and sending the units back to Cordis for reconciliation and destruction.
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
unknown device name - Product Code KOG
Causa
Sterility is compromised because the product is labeled as sterile, but the packages may have holes in them.
Acción
U.S. accounts were notified via recall letter dated 6/30/06 to cease use of the product and to return it to the firm. International accounts were also notified.