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
insulin infusion pump - Product Code LZG
Causa
The battery may turn the pump off without warning due to a design change in the battery.
Acción
Press release was issued on 7/13/06. Consignees, distributors and health care providers were issued a recall notice dated 7/13/06 instructing replacement of the power pack every two weeks until further notice.
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 - Product Code IOR
Causa
The wheelchairs with the travel ready option (trro) may contain incorrectly finished oval tie down brackets. the inner edge of the bracket may cause the tie-down straps (used to tie down the chairs during transport) to fray or be cut.
Acción
The recalling firm notified their consignees in a letter dated 6/26/06.
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
wheelchair - Product Code IOR
Causa
The wheelchairs with the travel ready option (trro) may contain incorrectly finished oval tie down brackets. the inner edge of the bracket may cause the tie-down straps (used to tie down the chairs during transport) to fray or be cut.
Acción
The recalling firm notified their consignees in a letter dated 6/26/06.
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
wheelchair - Product Code IOR
Causa
The wheelchairs with the travel ready option (trro) may contain incorrectly finished oval tie down brackets. the inner edge of the bracket may cause the tie-down straps (used to tie down the chairs during transport) to fray or be cut.
Acción
The recalling firm notified their consignees in a letter dated 6/26/06.
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
package insert - Product Code GKF
Causa
The package insert, which accompanied the qc reagents used with abl blood gas analyzers, referenced incorrect control ranges for hct (hematocrit) testing. the range stated on the package insert was too low to generate accurate hct test results (the control ranges were acceptable for the glucose and lactate testing).
Acción
The firm apprised their customers of this situation with a letter dated 5/24/2005. The letter requests that the customer remove the old (incorrect) package insert and replace it with a new (correct) insert which accompanied the customer letter. Should the customer have any questions, or need additional package inserts, the letter provides a toll-free contact telephone number.
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
Anti-streptolysin O Reagent - Product Code GTQ
Causa
The vial containing the r2 reagent is labeled as r1 reagent and if placed in the r1 slot of the analyzer, erroneous results will be obtained. (extremely low patient and control results).
Acción
Consignees were notified via recall letter dated 7/25/06 to cease using and to discard 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
in vitro diagnostic accessory - Product Code CHL
Causa
The dimensions and shape of the analyzer adaptor do not fit the analyzer tubes or probe, causing air to be aspirated with the blood sample and causing a deviation in the po2 sample results.
Acción
The firm issued a letter to their customers dated 6/9/2005. The letter reports the defect with the ABL5 Capillary Adapters and informs the customers that Radiometer reps will be replacing all of the customers'' ABL5 adaptors ASAP. The letter is accompanied by a single bag of new adaptors for the customers'' ''immediate needs'' and also provides a faxed response form which the customer can use to request additional adapters as required. In addition, should the customer choose to use the old adapters in their possession, the letter stresses and reiterates the ''Precautions and Warnings'' applicable for use of the ABL5 should air bubbles be observed in the measuring chamber by the user/operator.
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
accessory for use with blood gas analyzers - Product Code GIO
Causa
Capilliary end caps, an accessory for abl blood gas analyzers, leak blood from capillary tubes during transport.
Acción
The firm notified their customers of this recall action with a letter dated 3/22/2006. The letter was accompanied by a single bag of new end caps. The letter informs the customers of the ''leakage'' problem and asks that the customer examine their inventories and discard any of the referenced end caps found on-hand at any of their various locations. The letter also includes a response form to be faxed back to Radiometer indicating the amount of replacement capillary end caps required by the customer in addition to the one bag received. The recalling firm also notified the customers that the suspect end caps will all be replaced ASAP.
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
Cholesterol Reagent Set - Product Code CCH
Causa
Unexpected changes in qc and proficiency results due to qc and proficiency material matrix.
Acción
Consignees were notified via recall letter dated 6/12/06 to cease using the product, conduct a recall to the user level, destroy product on hand and to notify the firm via the response form of the amount destroyed for replacement purposes. International accounts were notified via email.
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
Cholesterol Reagent Set - Product Code CCH
Causa
Unexpected changes in qc and proficiency results due to qc and proficiency material matrix.
Acción
Consignees were notified via recall letter dated 6/12/06 to cease using the product, conduct a recall to the user level, destroy product on hand and to notify the firm via the response form of the amount destroyed for replacement purposes. International accounts were notified via email.
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
Cholesterol Reagent Set - Product Code CCH
Causa
Unexpected changes in qc and proficiency results due to qc and proficiency material matrix.
Acción
Consignees were notified via recall letter dated 6/12/06 to cease using the product, conduct a recall to the user level, destroy product on hand and to notify the firm via the response form of the amount destroyed for replacement purposes. International accounts were notified via email.
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
cardiac output monitor - Product Code DYG
Causa
Edwards lifesciences vigilance monitors with software release 5.3 or earlier may improperly cause the monitor to deliver power to the continuous cardiac output (cco) catheter without alerting the user to this situation. this can result in overheating and thermal damage to the cco catheter and serious patient injury.
Acción
Strategy to contact affected physicians accounts:
Edwards will communicate to all accounts with affected monitors using distribution and sales records to identify those accounts. Letter dated 07/07/2006. In addition Edwards will analyze all CCO catheter sales and identify all accounts not on the monitor distribution list and include those accounts on the communication listing.
Communication will be send via FedEx to the Risk Manager at each account with sufficient copies for the Heads of Departments of Surgery, Anesthesia, ICU, Nursing, Risk Management and Biomedical Engineering.
Edwards will follow up by phone with each account that does not initiate contact per the Recall Letter. Edwards will make three attempts to contact the account by phone and complete the recall process.
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
cell preparation system - Product Code LXG
Causa
During the cleaning cycle performed during the shutdown procedure of the beckman coulter fp1000 cell preparation system, fluid (diluted bleach) may drip from the probe in the location of the back reagent rack potentially resulting in bleach and/or water dripping into the reagents contaminating them and resulting in possible incorrect results.
Acción
A Product Corrective Action letter was sent on June 26, 2006 informing users that during the cleaning cycle performed during the shutdown procedure of the Beckman Coulter FP1000 Preparation System, fluid (diluted bleach) may drip from the probe in the location of the back reagent rack potentially resulting in bleach and/or water dripping into the reagents contaminating them and resulting in possible incorrect results.
To reduce the risk of incorrect results from dripping fluid, users were advised to remove all patient samples, reagents, controls, and calibrators before initiating the shutdown cycle of the Beckman Coulter FP1000. Software will be modified in the next version to prevent the possibility of dripping bleach during the shutdown cycle.
The Product Corrective Action letter is to be maintained as part of the customer''s laboratory Quality System documentation. The enclosed Response Form is to be completed and returned within 10 days to the recalling firm.
Customers are also advised to contact the firm or their local Beckman Coulter Representative if there are 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
Infrared lamp - Product Code ILY
Causa
Electrical safety hazard-when pulling on the cord of the ac adapter, to remove it from an outlet, the prongs on the ac adapter, may detach from the unit, damaging it and exposing the user to an electrical safety hazard.
Acción
Consignees were notified by telephone beginning 06/08/2006, followed by a letter on 06/23/2006.
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
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 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
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
shoulder prosthesis instrument - Product Code HWT
Causa
During provisional trialing, the instrument may become stuck in the humeral canal and require surgical removal.
Acción
U.S. and international distributors were notified of the recall via letter dated 6/30/2006 to check customer inventories and to return recalled product to the firm. Trial implants were redesigned and reworked to eliminate the problem.
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
bone screw - Product Code NDJ
Causa
Lack of assurance of sterility, as the sterile barrier packaging may have been compromised.
Acción
Hospital accounts were notified via recall letter dated 6/26/06 and distributor accounts were notified via recall letter dated 6/28/06 to return the product. Recall was extended to additional lots via recall letter dated 7/26/06.
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
bone screw - Product Code NDJ
Causa
Lack of assurance of sterility, as the sterile barrier packaging may have been compromised.
Acción
Hospital accounts were notified via recall letter dated 6/26/06 and distributor accounts were notified via recall letter dated 6/28/06 to return the product. Recall was extended to additional lots via recall letter dated 7/26/06.
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
bone screw - Product Code NDJ
Causa
Lack of assurance of sterility, as the sterile barrier packaging may have been compromised.
Acción
Hospital accounts were notified via recall letter dated 6/26/06 and distributor accounts were notified via recall letter dated 6/28/06 to return the product. Recall was extended to additional lots via recall letter dated 7/26/06.
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
bone screw - Product Code NDJ
Causa
Lack of assurance of sterility, as the sterile barrier packaging may have been compromised.
Acción
Hospital accounts were notified via recall letter dated 6/26/06 and distributor accounts were notified via recall letter dated 6/28/06 to return the product. Recall was extended to additional lots via recall letter dated 7/26/06.