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
Accessories, Wheelchair - Product Code KNO
Causa
Wheelchair seat may not properly support the user due to cracks in the plastic seat base.
Acción
The recalling firm notified dealers by certified letter on 1/19/03. The notification was flagged Attention:Product Recall and advised of seat base susceptibility to cracks and breakage. Dealers were intructed to respond with end user information. Dealers were also provided instructions and materials for crossbar and safety lock installation used with the drop seat bases. Dealers were additionally instructed to forward the provided notification letters to end users.
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
Glucose Oxidase, Glucose - Product Code CGA
Causa
Potential counterfeit product/box.
Acción
The recalling firm issued a recall letter to their direct accounts informing them of the problem and the need to return the product.
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
Stents, Drains And Dilators For The Biliary Ducts - Product Code FGE
Causa
After stent deployment, resistance can occur when pulling the deflated balloon back into the guiding catheter and this can result in an increased procedure time.
Acción
A recall letter was sent by Fed Ex to all affected customers for delivery on 01/30/04. Follow-up and product retrieval was done by the firm''s 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.
Notas adicionales en la data
Screw, Fixation, Bone - Product Code HWC
Causa
Product labeled as size 3.8x6 mm implant may actually be size 4.3x6 mm implant.
Acción
Zimmer was notified of this recall via letter dated 1/20/04 requesting Zimmer to remove all of this lot from inventory and from point of use locations.
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
Lift, Patient, Non-Ac-Powered - Product Code FSA
Causa
Excessive wear of the hanger bar bolt, that connects the lift arm to the sling spreader bar, may cause the bolt to snap allowing the patient to fall.
Acción
Letters were sent to all Faaborg lift customers on 11/29/01 and 01/24/04 advising the users that all bolts in connection with the hanger bar must be inspected, greased and tightened, and all defective or worn down bolts and washers must be changed. The 1/24/04 letters included an upgraded maintenance schedule and an Important Service/Safety Reminder, as well as a supply of hanger bar bolt washers. Any questions were directed to Moving Solutions' Service Department at 800-228-7980. Follow-up letters were sent to the accounts on 3/11/04, referencing the 1/21/04 letter and instructing the accounts not to use the lifts until the bolts have been inspected and retrofitted with the washers. Copies of the revised maintenance schedule and operating instructions were included.
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
Lift, Patient, Non-Ac-Powered - Product Code FSA
Causa
Excessive wear of the hanger bar bolt, that connects the lift arm to the sling spreader bar, may cause the bolt to snap allowing the patient to fall.
Acción
Letters were sent to all Faaborg lift customers on 11/29/01 and 01/24/04 advising the users that all bolts in connection with the hanger bar must be inspected, greased and tightened, and all defective or worn down bolts and washers must be changed. The 1/24/04 letters included an upgraded maintenance schedule and an Important Service/Safety Reminder, as well as a supply of hanger bar bolt washers. Any questions were directed to Moving Solutions' Service Department at 800-228-7980. Follow-up letters were sent to the accounts on 3/11/04, referencing the 1/21/04 letter and instructing the accounts not to use the lifts until the bolts have been inspected and retrofitted with the washers. Copies of the revised maintenance schedule and operating instructions were included.
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, Infusion, Insulin - Product Code LZG
Causa
A minor software anomaly results in an error in the calculation of the average glucose range that appears on one of the reports available in the model 7311 software.
Acción
Firm will send a Product Performance Update in all new shipments of the model 7311 version 5.0B software and it will be provided to all customers already receiving the version B software. When available, version 5.0c will be provided to customers with A or B software.
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.
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.
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.
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
Filter, Infusion Line - Product Code FPB
Causa
Lack of assurance of sterility.
Acción
Millipore notified direct and distributor accounts by Certified letter on 1/26/04. Users are requested to return product. Millipore France and Ireland coordinating recall to the international accounts.
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 And Tip, Suction - Product Code JOL
Causa
If the drain tube is assembled incorrectly, the suction pump will not operate as intended.
Acción
The accounts were telephoned on 2/2/04 and informed of the potential to re-assemble the suction pump drain tubing incorrectly after sterilization. The accounts were sent re-designed replacement tubing sets and were requested to return the old tubing sets to Richard Wolf.
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, Medical Examination, Ac Powered - Product Code KZF
Causa
Pivot joint on these ceiling mount lights may fail and lights may fall onto patients.
Acción
Firm will ask for subdistribution information from thier distributors via letter on 1/30/2004. Letters will be sent directly to users. Firm will retrofit all sites with suspect units with new pivot assemblies.
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
Clip, Implantable - Product Code FZP
Causa
Malformation of the hem-o-lok smx clip.
Acción
Consignees were notified by letter via Federal Express (Domestic consignees), Email (International and Weck Sales Representatives), and Fax (Weck Sales Representatives) beginning 01/23/2004.
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
Probe And Director, Gastro-Urology - Product Code FGM
Causa
The product's rear panel label could smear during use causing the serial number to be unreadible. this has the remote possibility of resulting in patient data from diagnostic tests being mixed-up or attributed to the wrong patient.
Acción
Letters dated February 6, 2004 were sent to the consignees. Enclosed with the letter to each consignee were label sticker(s) having the serial numbers of the device(s) purchased by the consignee. The letters instruct consignees to place the enclosed stickers on the devices over the previous back panel labels if the serial number of the label matches the serial number on the device. Special instructions for devices with smeared labels include the return of devices with unreadable serial numbers.
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 and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel data.
Notas adicionales en la data
unknown device name - Product Code NFN
Causa
The magnet at the end of the guidewire could break off.
Acción
Consignees were sent a notice dated January 27, 2004. The notice requested that consignees stop using the product and stated that a firm representative would contact the consignees. The firm''s representatives have retrieved all of the product at the 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
Valve, Non-Rebreathing - Product Code CBP
Causa
Valve cap may become loose and enter the air circuitry.
Acción
Consignees were notified on 2/3/2004 via certified mail and telephone.
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
Ventilator, Continuous, Facility Use - Product Code CBK
Causa
Valves may stick in the closed position due to manufacturing error.
Acción
Uninstalled ventilators were returned for change of the inhalation module. Otherwise, service technicians replaced the module in the field. Recall is complete.
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
Filter, Infusion Line - Product Code FPB
Causa
Lack of assurance of sterility.
Acción
Millipore notified direct and distributor accounts by Certified letter on 1/26/04. Users are requested to return product. Millipore France and Ireland coordinating recall to the international accounts.
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
Filter, Infusion Line - Product Code FPB
Causa
Lack of assurance of sterility.
Acción
Millipore notified direct and distributor accounts by Certified letter on 1/26/04. Users are requested to return product. Millipore France and Ireland coordinating recall to the international accounts.
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.
Radiation treatment software could potentially cause a healthcare practitioner to apply incorrect treatment regimen to patients undergoing brachytherapy.
Acción
The recalling firm notified end users by letters flagged 'Urgent Medical Device Correction' on 2/2/04. The notification reminds users to verify the decay factor before patient treatment. The letter also advises that instrument software be be updated commencing March 2004.
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, Urological - Product Code KOD
Causa
The foley trays contain a 16 french catheter instead of an 18 french catheter as specified by the product insert/labeling.
Acción
Consignees were notified by certified mail on 02/10/2004.
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
Stents, Drains And Dilators For The Biliary Ducts - Product Code FGE
Causa
Incorrect label states stent covered with 'permalume covering', product is uncovered.
Acción
Boston Scientific notified domestic and international accounts by letter on 1/28/04. Accounts are requested to return product.
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
Customer reprocessing methods for the reuseable hollow fiber dialyzers may damage the hollow fibers and result in blood leaks during dialysis.
Acción
Asahi visited each of the U.S. customers starting on 10/1/01, observing how the facility handles the dialyzer before pre-cleaning, during pre-cleaning and priming. The users were retrained in the reprocessing steps, emphasizing the controls and care to be taken during pre-cleaning, including the verification of water pressure.
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
Fluorometric, Cortisol - Product Code JFT
Causa
The package inserts contain incorrect control values for the urinary free cortisol extraction procedure.
Acción
Field Correction recall by Important Product Information letter dated 2/16/04, sent via e-mail to the Abbott international subsidiaries on the same date for notification of all of their accounts receiving the Cortisol reagents and X Systems Cortisol controls since March 2002. The accounts were informed of the incorrect values for the Cortisol controls, when using the urinary free cortisol extraction procedure, listed in the package inserts of the reagent kits as well as the controls. The letters contained a table listing the incorrect values and the correct values for each of the products, and the users were instructed to use the corrected values as provided in the letter.