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
Advisory to alert users to assure that the hemofilter of the blood line is in the horizontal position to avoid kinking of the bloodline tubing to avoid hemolysis, and to show the compatible blood tubing sets to be used with the bm11/bm11a blood monitor pump and bm25 system ultrafiltration hemodialysis system.
Acción
Important Product Information letters dated 12/21/05 were sent to all BM-series instrument users, informing them of the potential for kinking of the tubing if the hemofilter is in the vertical position and the compatibility testing conducted on certain blood tubing sets for use with the BM-series instruments and Baxter''s recommendation that the following sets be used with the BM-series instruments: a) product code 5M3006M for use with the BM 11 and the BM 11a, when the BM 11a is used as a stand alone device; b) product code 5M3048 for use with the BM 11a when operated as part of the BM 25 System; and c) product code 5M3046 for use with the BM 14 part of the BM 25 System. Please note that the BM 14 cannot be used as a stand alone instrument. A fourth bloodline manufactured by Nextron and identified as a BM11 Low Volume Tubing (Baxter product code 5M3132 and Nextron code DHZ0006) was found to be unqualified for use for the BM series instruments. A recommended blood tubing sets and setup guide with diagrams was included with the letter. Both the letter and the setup guide contained the following warning: ''During machine set up, verify that the selected blood tubing set has been recommended for use with the Baxter bm11/bm11a Blood Monitor Pump and the Baxter bm25 System. Using non-recommended blood tubing sets, even if the blood tubing set fits and appears to function correctly, may have clinical consequences. These consequences may include blood tubing kinking, which may cause hemolysis. Clinical consequences of returning hemolyzed blood to a patient range from back pain and shortness of breath up to and including death.'' The users were also informed that the warning was being included in a new revision of the Operator''s Manual, and were requested to call Baxter''s Center for Service at 1-888-229-0001 to return any stocks of product code 5M3132 for credit. Any questions were directed to the Center for One Baxter at 1-800-422-9837.
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, Ph, Stomach - Product Code FFT
Causa
Certain lots have a manufacturing defect that allows the water pushed through the catheter to travel back into the connector of the digitrapper ph recorder. medtronic has determined that patient safety is not compromised, but catheter function may be affected and damage may result to the digitrapper ph recorder.
Acción
Letters will be sent to distributors, end-users and Medtronic Field Personnel. The end-user will be asked to return via fax a confirmation/customer receipt. Letters identify the affected catalog number and lot numbers. Customers are asked to return affected product and will receive replacement 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
Cystometric Gas (Carbon-Dioxide) On Hydraulic Device - Product Code FAP
Causa
The product is mislabeled. the labeling on the front of the packaging states that product contains latex. however, the back of the package contains a latex- free symbol.
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, Micro, For Clinical Use - Product Code JJF
Causa
Under certain conditions an incorrect tube id (barcode) can be displayed and printed on the runtime panel report in cxp cytometer software version 2.0.
Acción
A Product Corrective Action letter will be mailed the week of Nov 28, 2005 to all FC500 wi CXP Software customers. Each user will be contacted initially and then once more (if needed) in order to determine the rate of response from the Response form 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.
Risk of fire. the manufacturing process may have the potential to damage the insulation of the heater wire in circuits within the specified lot range. this may lead to a potential risk of fire.
Acción
On December 20th, 2005 the firm sent the notification letter instructing consignees to check and destroy any stock in the affected lot range. A fax-back Device Recall Response Form was included with the letter and will be used for the company''s effectiveness checks.
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.
Risk of fire. the manufacturing process may have the potential to damage the insulation of the heater wire in circuits within the specified lot range. this may lead to a potential risk of fire.
Acción
On December 20th, 2005 the firm sent the notification letter instructing consignees to check and destroy any stock in the affected lot range. A fax-back Device Recall Response Form was included with the letter and will be used for the company''s effectiveness checks.
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.
Risk of fire. the manufacturing process may have the potential to damage the insulation of the heater wire in circuits within the specified lot range. this may lead to a potential risk of fire.
Acción
On December 20th, 2005 the firm sent the notification letter instructing consignees to check and destroy any stock in the affected lot range. A fax-back Device Recall Response Form was included with the letter and will be used for the company''s effectiveness checks.
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 integrity of the sterile unit package may become compromised.
Acción
Consignees were notified via certified mail, return receipt on 11/30/2005. The neonatal recall was faxed to the two consignees with a method 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
Glucose Oxidase, Glucose - Product Code CGA
Causa
Software error may report higher results for glucose and lactate.
Acción
Instrumentation Laboratory notified customers by letter dated December 2005 on 12/16/2005. Customers were notifed if the error message occurs the lab should diable the glucose and lactate channels or remove cartridge. A software upgrade will be released in early 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.
22 gauge needle guides were intermixed with 21 gauge guides and labeled as 21 gauge needle guides.
Acción
Affected customers were contacted via telephone between December 12-19, 2005. Provided instructions for returning defective product. Notification letter was distributed to all customers on December 14, 2005 instructing customers to discontinue use of the needle guide and return remaining portion.
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
Regulator, Pressure, Gas Cylinder - Product Code CAN
Causa
The units may experience a delay in oxygen flow upon initial actuation.
Acción
The recalling firm sent a recall letter, dated 12/21/05, 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
Regulator, Pressure, Gas Cylinder - Product Code CAN
Causa
The units may experience a delay in oxygen flow upon initial actuation.
Acción
The recalling firm sent a recall letter, dated 12/21/05, 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.
When using a third party dictation accessory with the isite pacs, a malfunction may occur that would result in the petient/exam selected and shown may be different on the radiologist console and diagnostic display screens.
Acción
On 12/20/05, the firm initiated the recall and its notification was via letters informing its customers of the corrective action.
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 adjustment knob tower on one device was found to have broken off from the body of the instrument. this did not happend during a surgery and is believed to have been caused by the instrument being dropped or otherwise mishandled during hospital processing. a manufacturer evaluation of the device determined that the laser weld attaching the knob to the body was not to specification.
Acción
The adjustment know tower on one device was found t have broken off from the body of the instrument. This did not happend during a surgery, and is belived tohave been caused by the instrument being dropped or otherwise mishandled during hospital processing. A manufacturer evaluation of the device determined that the laser weld attaching the knob to the body was not to specification.
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.
Two lots of products were mislabeled; a lot of twenty style 468 breast implants and a lot of twenty style 163 breast implants. in error, the labels for these two lots were switched during packaging. as a result, a total of 40 devices were mislabeled.
Acción
On Wednesday, 14-December-2005, Inamed began calling affected customers to notify them of the voluntary recall.
At the end of business on Wednesday, 14-December-2005, Inamed distributed Recall Notification Letters via Federal Express overnight mail directly to affected customers.
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.
Two lots of products were mislabeled; a lot of twenty style 468 breast implants and a lot of twenty style 163 breast implants. in error, the labels for these two lots were switched during packaging. as a result, a total of 40 devices were mislabeled.
Acción
On Wednesday, 14-December-2005, Inamed began calling affected customers to notify them of the voluntary recall.
At the end of business on Wednesday, 14-December-2005, Inamed distributed Recall Notification Letters via Federal Express overnight mail directly to affected customers.
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
Test, Sickle Cell - Product Code GHM
Causa
Firm received one report of a false negative with the positive control. internal testing by the firm has shown that the kit lot may result in invalid or false negative interpretations.
Acción
Chembio phoned the consignees and followed up by faxing the recall letters (dated 12/15/05) & response forms on 12/22/05.
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.
An issue exists with a specific subset of sigma series pacemakers that may fail due to separation of interconnect wires from the hybrid circuit. this failure mechanism may present clinically as loss of rate response, premature battery depletion, intermittent or total loss of telemetry, or not output. there have been no reported patient injuries or deaths due to this issue.
Acción
Press Release was issued 11/29/05. Hospital/physician letters sent via registered mail on 11/29/05 for delivery on 12/01/05. Unimplanted devices are being retrieved. The Physician letter describes the issue, root cause, the probability of reoccurrence and provides recommendations. A list of affected serial numbers that the physician is following or has implanted is attached to the letter. The letter also provides medtronic's website in which regular updates on the ongoing actual performance are listed in their Product Performance Report. Medtronic is providing a replacement device should the Physician and patient elect to replace the affected implanted device.
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
System software assigns a calibrator default volume of 2.0ul when field is left empty by operator at time assay parameters set. patient results could be affected if the volume required is not 2.0 ul.
Acción
Firm initiated recall to all consignees via letter dated 12/08/05.
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
Glucose Oxidase, Glucose - Product Code CGA
Causa
Product may be defective and may give low inaccurate glucose results.
Acción
Recall was initiated in early November. Notifications were sent on November 21, 2005. The firm has also posted recall notices on its website, and Customer Service Scripting will be available to address questions from callers.
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
Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers - Product Code LTJ
Causa
There is the possibility of high results with sera expected to have non-detectable levels of tpsa if these reagent lots are used in combination on the modular analytics e170 analyzer.
Acción
Consignees were notified of the incompatibility via reagent bulletin dated 12/7/05.
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
Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers - Product Code LTJ
Causa
There is the possibility of high results with sera expected to have non-detectable levels of tpsa if these reagent lots are used in combination on the modular analytics e170 analyzer.
Acción
Consignees were notified of the incompatibility via reagent bulletin dated 12/7/05.
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
System, X-Ray, Film Marking, Radiographic - Product Code JAC
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 may separate from the catheter sheath inner core during insertion of the graft. the delivery catheter is being recalled. the implanted devices are not affected.
Acción
The three affected hospitals were contacted telephone and in writing (Recall Letters) sent via FedEx Endologix field personnel are scheduled to remove the product units by 12/16/05.
Notices for Phase II of recall to 8 additional consignees for 6 additional models (9 lots) being recalled mailed 12/19-12/22/05.
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.
The tip may separate from the catheter sheath inner core during insertion of the graft. the delivery catheter is being recalled. the implanted devices are not affected.
Acción
The three affected hospitals were contacted telephone and in writing (Recall Letters) sent via FedEx Endologix field personnel are scheduled to remove the product units by 12/16/05.
Notices for Phase II of recall to 8 additional consignees for 6 additional models (9 lots) being recalled mailed 12/19-12/22/05.