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
Pulmonetic systems has identified the potential of a printed circuit board malfunction, which can result in a ventilator malfunctio (e.G. vent inop, hw fault, xducer fault) and possibly resulting in failure of the ventilator to breathe for the patient. this malfunction may occur without an accompanying audible alarm.
Acción
Urgent Medical Device Recall letter dated 11/09/05 is being sent via certified mail to affected customers. The letter informs customers of the issue. A Pulmonetic Systems representative will contact the customer within 72 hours to schedule a printed circuit board replacement. Customers are advised that in the interim all ventilator-dependent patients should be constantly monitored by qualified personnel to ensure that if a malfunction occurs, alternate ventilation can be provided.
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
Pulmonetic systems has identified the potential of a printed circuit board malfunction, which can result in a ventilator malfunctio (e.G. vent inop, hw fault, xducer fault) and possibly resulting in failure of the ventilator to breathe for the patient. this malfunction may occur without an accompanying audible alarm.
Acción
Urgent Medical Device Recall letter dated 11/09/05 is being sent via certified mail to affected customers. The letter informs customers of the issue. A Pulmonetic Systems representative will contact the customer within 72 hours to schedule a printed circuit board replacement. Customers are advised that in the interim all ventilator-dependent patients should be constantly monitored by qualified personnel to ensure that if a malfunction occurs, alternate ventilation can be provided.
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 product is mislabeled in that size 6 right foundation may contain size 8 right 3d knee non-porous baseplates and vice versa. device is intended to aid surgeon in relieving knee pain and restoring knee joint function.
Acción
Firm initiated recall on 11/03/05 via letter to all 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
Pump, Infusion - Product Code FRN
Causa
Possible shorting of some printed circuit boards could result in a possible interruption of therapy or cause the pump to fail the power-on self test.
Acción
Baxter sent Urgent Device Correction letters dated 11/7/05 to the user accounts, advising them of the potential for the circuit boards in the 6060 pump to fail due to a problem that occurred in the supplier's manufacturing process. The letter included a list of 6060 pump serial numbers sent to the user that may contain an affected circuit board. To mitigate safety risks to the patient, Baxter advised customers to immediately discontinue use of the pump for therapies where interruption of the infusion could cause immediate patient harm. In addition, the pump is not to be used if it fails the Power-On Self Test. The accounts were instructed to contact Baxter Medication Delivery Services at 1-800-843-7867 for information regarding the return process for the affected 6060 pumps for correction.
Baxter sent follow-up letters dated 2/16/06 to the accounts, to the attention of the Director of Biomedical Engineering, informing them that Baxter has sufficient quantities of replacement circuit boards to begin the repairs. The accounts were requested to review the enclosed list of serial numbers for accuracy and telephone Baxter at 1-800-843-7867 to schedule the return of any 6060 Infusion Pump that requires replacement of the circuit board.
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
Stretcher, Wheeled - Product Code FPO
Causa
The firm received complaints of the stretchers folding. a fold is when the stretcher lowers on its own to either the next position, or any of the other seven postions of the stretcher.
Acción
The firm went out to customers who had complained of a 'fold' and installed the kit on the stretcher that had experienced the fold and on all other PROflexx stretchers owned by the customer. These customers had received a recall letter, dated March 28, 2003. For customers that had not complained of the stretchers 'folding', the firm sent a letter dated June 24, 2003, to all distributors requesting the distributor provide the firm with a list of customers that had received the PROflex stretchers. Once the firm had a list of all customers, they sent them a letter offering them the kit as an enhancement that they could purchase to help reduce the possibility of false locking.
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
Spinal Vertebral Body Replacement Device - Product Code MQP
Causa
Implants were manufactured without radiographic markers.
Acción
Firm initiated phone contact of all Sales Representatives who received lot and surgeons who have implanted lot on 11/02/05. Recall Letters to be sent to surgeons who have implanted affected 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
Stretcher, Wheeled - Product Code FPO
Causa
The firm received complaints of the stretchers folding. a fold is when the stretcher lowers on its own to either the next position, or any of the other seven postions of the stretcher.
Acción
The firm went out to customers who had complained of a 'fold' and installed the kit on the stretcher that had experienced the fold and on all other PROflexx stretchers owned by the customer. These customers had received a recall letter, dated March 28, 2003. For customers that had not complained of the stretchers 'folding', the firm sent a letter dated June 24, 2003, to all distributors requesting the distributor provide the firm with a list of customers that had received the PROflex stretchers. Once the firm had a list of all customers, they sent them a letter offering them the kit as an enhancement that they could purchase to help reduce the possibility of false locking.
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
Appliance, Fixation, Spinal Intervertebral Body - Product Code KWQ
Causa
Modification to labeling for surgical implant.
Acción
Firm contact of Sales Agencies by phone began on 11/11/05 to inform of changes to Surgical Techniques. Letter to surgeons using SC-AcuFix Systems as of 06/01/05 sent 11/14/05.
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
Bracket, Plastic, Orthodontic - Product Code DYW
Causa
Two part numbers of damon 3 brackets (491-4210 and 491-4211) were prematurely
shipped domestically prior to receiving fda 510k market clearance.
Acción
Telephone notification will be followed by letters sent via U.S. first class mail with mailing to commence on Thursday, 11/3/05.
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
Bracket, Plastic, Orthodontic - Product Code DYW
Causa
Two part numbers of damon 3 brackets (491-4210 and 491-4211) were prematurely
shipped domestically prior to receiving fda 510k market clearance.
Acción
Telephone notification will be followed by letters sent via U.S. first class mail with mailing to commence on Thursday, 11/3/05.
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
Pump, Infusion - Product Code FRN
Causa
Failures within the pca profile as well as incidents resulting in interruptions of therapy in various profiles.
Acción
Baxter sent recall letters dated 11/14/05 to all of their 6060 pump customers on the same date via DHL overnight delivery. The accounts were informed of the reports of failures within the PCA profile and interruptions of therapy in various profiles. Due to the obsolescence of certain critical components, Baxter is conducting a controlled removal of all 6060 pumps from the market. Baxter will coordinate with customers individually to ensure a smooth transition to a substitute device. Baxter provided interim instructions to discontinue use of the PCA profile to avoid over infusion or non-delivery conditions, and to discontinue the use of the pump for therapies where interruption of the infusion could cause immediate patient harm.
Baxter representatives telephoned each account within 48 hours of the letter, and visited them within a week to help the customers transition to other infusion pumps. A press release issued on 11/15/05.
Baxter sent a follow-up recall letter to the accounts on 6/20/06, informing them that service repairs for the 6060 Infusion Pump will cease after 12/31/06, and compensation requests cannot be processed for pumps received after 12/31/06. Production of sets for the 6060 will cease on 10/1/06, and will not be available after 12/31/06. The accounts were requested to complete and fax back to Baxter the enclosed reply form, indicating the current inventory of 6060 pumps remaining at the facility.
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
Bit, Surgical - Product Code GFG
Causa
The bit may bend or fracture during use.
Acción
Consignees were notified to return the product via letter dated 11/10/05.
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
Introducer, Catheter - Product Code DYB
Causa
Mislabeled as 9.5f actually contains 10.5f.
Acción
The recalling firm issued letters to their direct accounts via fax on 11/7/05. Letters to the hospital accounts were mailed via UPS overnight on 11/14/05.
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
Massager, Therapeutic, Electric - Product Code ISA
Causa
The massager may develop a crack in the cord insulation where it exits out of the strain relief. a crack in the insulation may expose live conductors resulting in a possible electric shock and injury to the user.
Acción
Wahl sent recall letters dated 10/31/05 to their direct accounts on 10/28/05, informing them of the potential for cracks in the power cord at the base of the unit resulting in possible electric shock and injury to the user. The accounts were requested to return all stocks of both massagers from their warehouse and retail store stock to Wahl for replacement of the white power cord with a black power cord from a different supplier. The accounts were also requested to supply Wahl with a list of customers who purchased these massagers after May 2003 so that they may be notified of the recall and have their massagers corrected. Wahl Clipper sent point of purchase ''Safety Recall Notice'' posters to the retail stores where these products were sold. The posters have guidance for consumers on returning their units and will be displayed for ninety (90) days. Wahl Clipper has posted the ''Safety Recall Notice'' on its website (www.wahl.com) with a toll-free telephone number (800-334-4627) for consumers to contact consumer service for guidance on returning their unit. The website notice will be displayed for ninety (90) days.
To the extent possible, Wahl Clipper will contact consumers directly to notify them of this repair recall to the extent that contact information 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
Massager, Therapeutic, Electric - Product Code ISA
Causa
The massager may develop a crack in the cord insulation where it exits out of the strain relief. a crack in the insulation may expose live conductors resulting in a possible electric shock and injury to the user.
Acción
Wahl sent recall letters dated 10/31/05 to their direct accounts on 10/28/05, informing them of the potential for cracks in the power cord at the base of the unit resulting in possible electric shock and injury to the user. The accounts were requested to return all stocks of both massagers from their warehouse and retail store stock to Wahl for replacement of the white power cord with a black power cord from a different supplier. The accounts were also requested to supply Wahl with a list of customers who purchased these massagers after May 2003 so that they may be notified of the recall and have their massagers corrected. Wahl Clipper sent point of purchase ''Safety Recall Notice'' posters to the retail stores where these products were sold. The posters have guidance for consumers on returning their units and will be displayed for ninety (90) days. Wahl Clipper has posted the ''Safety Recall Notice'' on its website (www.wahl.com) with a toll-free telephone number (800-334-4627) for consumers to contact consumer service for guidance on returning their unit. The website notice will be displayed for ninety (90) days.
To the extent possible, Wahl Clipper will contact consumers directly to notify them of this repair recall to the extent that contact information 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
Dilator, Catheter, Ureteral - Product Code EZN
Causa
There is a potential for the lumen to collapse and prevent passage over a guidewire.
Acción
Consignees were notified via overnight courier on 11/7&8/2005
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
Dialyzer, High Permeability With Or Without Sealed Dialysate System - Product Code KDI
Causa
Potential for fluid or air to be passed through the venous line clamp if the tubing is not centered in the clamp and extends beyond the edge of the clamp's pinch zone. this could result in an air emboli condition.
Acción
Baxter sent Urgent Device Correction letters dated 11/18/05 to all System 1000, TINA, Aurora and Arena Hemodilaysis Instrument customers via first class mail on the same date, to the attention of the Hemodialysis Administrator. The letters informed the accounts that the potential exists for fluid or air to be passed through the venouus line clamp that could result in an air emboli condition. This condition can occur when the tubing is not centered on the clamp and extends beyond the edge of the clamp''s pinch zone. Baxter will make arrangements to upgrade the instruments with either a linear or rotary venous line clamp upgrade as soons as they become available within the next three months. The letters included copies of a diagram showing the correct and incorrect placement of the tubing in the clamp, and a Technical Service Bulletin that provided an adjustment procedure to perform an interim correction to the linear line clamp configuration prior to the upgrade. Any questions regarding the execution of this procedure were directed to Baxter Global Technical Services at 1-800-553-6898.
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
Electrode, Electrocardiograph, Multi-Function - Product Code MLN
Causa
The apex/anterior and the sternum/posterior pad labels are located in reverse position to the wire and connector.
Acción
Philips Medical sent the recall notification letter 11/30/05 via FedEx
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
Anesthesia Conduction Kit - Product Code CAZ
Causa
Tray may contain holes compromising the sterility of the device.
Acción
Smiths Medical ASD notffied accounts by letter via UPS or Fedex on November 17, 2005. Customers and dealers are directed to fax back the attached Reply Letter to Smiths Medical, Keene even if the customer/dealer no longer has affected products in inventory
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
Anesthesia Conduction Kit - Product Code CAZ
Causa
Tray may contain holes compromising the sterility of the device.
Acción
Smiths Medical ASD notffied accounts by letter via UPS or Fedex on November 17, 2005. Customers and dealers are directed to fax back the attached Reply Letter to Smiths Medical, Keene even if the customer/dealer no longer has affected products in inventory
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
Anesthesia Conduction Kit - Product Code CAZ
Causa
Tray may contain holes compromising the sterility of the device.
Acción
Smiths Medical ASD notffied accounts by letter via UPS or Fedex on November 17, 2005. Customers and dealers are directed to fax back the attached Reply Letter to Smiths Medical, Keene even if the customer/dealer no longer has affected products in inventory
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
Anesthesia Conduction Kit - Product Code CAZ
Causa
Tray may contain holes compromising the sterility of the device.
Acción
Smiths Medical ASD notffied accounts by letter via UPS or Fedex on November 17, 2005. Customers and dealers are directed to fax back the attached Reply Letter to Smiths Medical, Keene even if the customer/dealer no longer has affected products in inventory
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
Anesthesia Conduction Kit - Product Code CAZ
Causa
Tray may contain holes compromising the sterility of the device.
Acción
Smiths Medical ASD notffied accounts by letter via UPS or Fedex on November 17, 2005. Customers and dealers are directed to fax back the attached Reply Letter to Smiths Medical, Keene even if the customer/dealer no longer has affected products in inventory
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
Anesthesia Conduction Kit - Product Code CAZ
Causa
Tray may contain holes compromising the sterility of the device.
Acción
Smiths Medical ASD notffied accounts by letter via UPS or Fedex on November 17, 2005. Customers and dealers are directed to fax back the attached Reply Letter to Smiths Medical, Keene even if the customer/dealer no longer has affected products in inventory