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.
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
Plate, Fixation, Bone - Product Code HRS
Causa
Screwdriver pilot taper tip can break during surgery.
Acción
Between 11/1 and 11/7/05, the recalling firm visited 12 of the consignees and collected the product, and phoned the other 2 consignees and requested return of 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.
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.
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.
A potential safety related problem associated with the pnuepac babypac ventilator model 100 has been discovered in that the interface between the air input hose and the air input fitting may leak, and if tightened too much, the air input fitting may loosen when trying to remove the air hose.
Acción
Consignees were provided a Safety Action Bulletin, number 05-SAB05, dated 12/05/05. This requests that affected devices be quarantined, Smiths Medical be contacted and devices ultimately be returned to Smiths Medical Pm, Inc. Service Departmentfor repair.
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
Mesh, Surgical, Polymeric - Product Code FTL
Causa
Lots of proceed surgical mesh may delaminate from the polypropylene mesh during certain hernia repairs. exposure of the polypropylene layer to the bowel prior to reperitonealization could increase the risk of adhesions and bowel fistulization.
Acción
The recall was initiated on 12/21/2005. The recall to the customers were initiate via letter with return receipt on 1/4/2006.
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
Alpha-1-Lipoprotein, Antigen, Antiserum, Control - Product Code DER
Causa
These specific protein assays are not meeting the 57-day on board stability claim.
Acción
A Device Correction letter identifying the changes being made to the frequency of QC monitoring for these assays, will be distributed to all AEROSET and ARCHITECT c8000 customers which utilize the IgM, Prealbumin and Apolipoprotein Al Specifc Protein assays on November 10,2005 via direct mailing. Outside the U.S. each country organization will need to determine the appropriate method for the effectiveness check..
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
Dislodger, Stone, Basket, Ureteral, Metal - Product Code FFL
Causa
The basket wire assembly may detach from the drive wire while in the patient.
Acción
U.S. and foreign consignees were notified via letter dated 12/20/05 and requested to return stocks on hand. Distributors were requested to notify their 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
Igm, Antigen, Antiserum, Control - Product Code DFT
Causa
These specific protein assays are not meeting the 57-day on board stability claim.
Acción
A Device Correction letter identifying the changes being made to the frequency of QC monitoring for these assays, will be distributed to all AEROSET and ARCHITECT c8000 customers which utilize the IgM, Prealbumin and Apolipoprotein Al Specifc Protein assays on November 10,2005 via direct mailing. Outside the U.S. each country organization will need to determine the appropriate method for the effectiveness check..
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
Prealbumin, Antigen, Antiserum, Control - Product Code JZJ
Causa
These specific protein assays are not meeting the 57-day on board stability claim.
Acción
A Device Correction letter identifying the changes being made to the frequency of QC monitoring for these assays, will be distributed to all AEROSET and ARCHITECT c8000 customers which utilize the IgM, Prealbumin and Apolipoprotein Al Specifc Protein assays on November 10,2005 via direct mailing. Outside the U.S. each country organization will need to determine the appropriate method for the effectiveness check..
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 extension sets contain microbore female luers that may crack during use, resulting in leakage of medication or incomplete delivery of medication.
Acción
Baxter sent Urgent Product Recall letters dated 8/3/05 to their customers, to the attention of the Director of Materials Management, via first class mail on the same date. The accounts were informed of the microbore female luers that may crack during use, resulting in the possible under delivery or incomplete delivery of medication. The accounts were instructed to examine their inventory for the affected lots of product, remove it from inventory and return it to Baxter for credit. Any questions were directed to the Center for One Baxter at 1-800-422-9837. Baxter extended the recall to include additional lots and product codes via letter dated 12/15/05. The letters referenced the 8/3/05 letter, including a copy of that letter, and listed the affected lots of sets. The instructions for return of the product remained the same as that described in the 8/3/05 letter.
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 extension sets contain microbore female luers that may crack during use, resulting in leakage of medication or incomplete delivery of medication.
Acción
Baxter sent Urgent Product Recall letters dated 8/3/05 to their customers, to the attention of the Director of Materials Management, via first class mail on the same date. The accounts were informed of the microbore female luers that may crack during use, resulting in the possible under delivery or incomplete delivery of medication. The accounts were instructed to examine their inventory for the affected lots of product, remove it from inventory and return it to Baxter for credit. Any questions were directed to the Center for One Baxter at 1-800-422-9837. Baxter extended the recall to include additional lots and product codes via letter dated 12/15/05. The letters referenced the 8/3/05 letter, including a copy of that letter, and listed the affected lots of sets. The instructions for return of the product remained the same as that described in the 8/3/05 letter.
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 extension sets contain microbore female luers that may crack during use, resulting in leakage of medication or incomplete delivery of medication.
Acción
Baxter sent Urgent Product Recall letters dated 8/3/05 to their customers, to the attention of the Director of Materials Management, via first class mail on the same date. The accounts were informed of the microbore female luers that may crack during use, resulting in the possible under delivery or incomplete delivery of medication. The accounts were instructed to examine their inventory for the affected lots of product, remove it from inventory and return it to Baxter for credit. Any questions were directed to the Center for One Baxter at 1-800-422-9837. Baxter extended the recall to include additional lots and product codes via letter dated 12/15/05. The letters referenced the 8/3/05 letter, including a copy of that letter, and listed the affected lots of sets. The instructions for return of the product remained the same as that described in the 8/3/05 letter.
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 extension sets contain microbore female luers that may crack during use, resulting in leakage of medication or incomplete delivery of medication.
Acción
Baxter sent Urgent Product Recall letters dated 8/3/05 to their customers, to the attention of the Director of Materials Management, via first class mail on the same date. The accounts were informed of the microbore female luers that may crack during use, resulting in the possible under delivery or incomplete delivery of medication. The accounts were instructed to examine their inventory for the affected lots of product, remove it from inventory and return it to Baxter for credit. Any questions were directed to the Center for One Baxter at 1-800-422-9837. Baxter extended the recall to include additional lots and product codes via letter dated 12/15/05. The letters referenced the 8/3/05 letter, including a copy of that letter, and listed the affected lots of sets. The instructions for return of the product remained the same as that described in the 8/3/05 letter.
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 extension sets contain microbore female luers that may crack during use, resulting in leakage of medication or incomplete delivery of medication.
Acción
Baxter sent Urgent Product Recall letters dated 8/3/05 to their customers, to the attention of the Director of Materials Management, via first class mail on the same date. The accounts were informed of the microbore female luers that may crack during use, resulting in the possible under delivery or incomplete delivery of medication. The accounts were instructed to examine their inventory for the affected lots of product, remove it from inventory and return it to Baxter for credit. Any questions were directed to the Center for One Baxter at 1-800-422-9837. Baxter extended the recall to include additional lots and product codes via letter dated 12/15/05. The letters referenced the 8/3/05 letter, including a copy of that letter, and listed the affected lots of sets. The instructions for return of the product remained the same as that described in the 8/3/05 letter.
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 extension sets contain microbore female luers that may crack during use, resulting in leakage of medication or incomplete delivery of medication.
Acción
Baxter sent Urgent Product Recall letters dated 8/3/05 to their customers, to the attention of the Director of Materials Management, via first class mail on the same date. The accounts were informed of the microbore female luers that may crack during use, resulting in the possible under delivery or incomplete delivery of medication. The accounts were instructed to examine their inventory for the affected lots of product, remove it from inventory and return it to Baxter for credit. Any questions were directed to the Center for One Baxter at 1-800-422-9837. Baxter extended the recall to include additional lots and product codes via letter dated 12/15/05. The letters referenced the 8/3/05 letter, including a copy of that letter, and listed the affected lots of sets. The instructions for return of the product remained the same as that described in the 8/3/05 letter.
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 extension sets contain microbore female luers that may crack during use, resulting in leakage of medication or incomplete delivery of medication.
Acción
Baxter sent Urgent Product Recall letters dated 8/3/05 to their customers, to the attention of the Director of Materials Management, via first class mail on the same date. The accounts were informed of the microbore female luers that may crack during use, resulting in the possible under delivery or incomplete delivery of medication. The accounts were instructed to examine their inventory for the affected lots of product, remove it from inventory and return it to Baxter for credit. Any questions were directed to the Center for One Baxter at 1-800-422-9837. Baxter extended the recall to include additional lots and product codes via letter dated 12/15/05. The letters referenced the 8/3/05 letter, including a copy of that letter, and listed the affected lots of sets. The instructions for return of the product remained the same as that described in the 8/3/05 letter.
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 Urinalysis System - Product Code KQO
Causa
When reading the nitrite parameter on the teco diagnostics urs-10 strips, some positive nitrite samples may be read by the machine as negative.
Acción
On December 22nd,2005 the firm sent the notification letter along with a replacement unit of TC-101. These letters and replacement units were send via Fed ex ground and the tracking numbers and serial numbers of the sent units are also noted. Also noted are the return authorization numbers assigned to each respective customer.
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 extension sets contain microbore female luers that may crack during use, resulting in leakage of medication or incomplete delivery of medication.
Acción
Baxter sent Urgent Product Recall letters dated 8/3/05 to their customers, to the attention of the Director of Materials Management, via first class mail on the same date. The accounts were informed of the microbore female luers that may crack during use, resulting in the possible under delivery or incomplete delivery of medication. The accounts were instructed to examine their inventory for the affected lots of product, remove it from inventory and return it to Baxter for credit. Any questions were directed to the Center for One Baxter at 1-800-422-9837. Baxter extended the recall to include additional lots and product codes via letter dated 12/15/05. The letters referenced the 8/3/05 letter, including a copy of that letter, and listed the affected lots of sets. The instructions for return of the product remained the same as that described in the 8/3/05 letter.
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 extension sets contain microbore female luers that may crack during use, resulting in leakage of medication or incomplete delivery of medication.
Acción
Baxter sent Urgent Product Recall letters dated 8/3/05 to their customers, to the attention of the Director of Materials Management, via first class mail on the same date. The accounts were informed of the microbore female luers that may crack during use, resulting in the possible under delivery or incomplete delivery of medication. The accounts were instructed to examine their inventory for the affected lots of product, remove it from inventory and return it to Baxter for credit. Any questions were directed to the Center for One Baxter at 1-800-422-9837. Baxter extended the recall to include additional lots and product codes via letter dated 12/15/05. The letters referenced the 8/3/05 letter, including a copy of that letter, and listed the affected lots of sets. The instructions for return of the product remained the same as that described in the 8/3/05 letter.
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 extension sets contain microbore female luers that may crack during use, resulting in leakage of medication or incomplete delivery of medication.
Acción
Baxter sent Urgent Product Recall letters dated 8/3/05 to their customers, to the attention of the Director of Materials Management, via first class mail on the same date. The accounts were informed of the microbore female luers that may crack during use, resulting in the possible under delivery or incomplete delivery of medication. The accounts were instructed to examine their inventory for the affected lots of product, remove it from inventory and return it to Baxter for credit. Any questions were directed to the Center for One Baxter at 1-800-422-9837. Baxter extended the recall to include additional lots and product codes via letter dated 12/15/05. The letters referenced the 8/3/05 letter, including a copy of that letter, and listed the affected lots of sets. The instructions for return of the product remained the same as that described in the 8/3/05 letter.
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 extension sets contain microbore female luers that may crack during use, resulting in leakage of medication or incomplete delivery of medication.
Acción
Baxter sent Urgent Product Recall letters dated 8/3/05 to their customers, to the attention of the Director of Materials Management, via first class mail on the same date. The accounts were informed of the microbore female luers that may crack during use, resulting in the possible under delivery or incomplete delivery of medication. The accounts were instructed to examine their inventory for the affected lots of product, remove it from inventory and return it to Baxter for credit. Any questions were directed to the Center for One Baxter at 1-800-422-9837. Baxter extended the recall to include additional lots and product codes via letter dated 12/15/05. The letters referenced the 8/3/05 letter, including a copy of that letter, and listed the affected lots of sets. The instructions for return of the product remained the same as that described in the 8/3/05 letter.
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.
Software anomaly that affects the panorama telepack where if communications are lost during standby, certain alarms which appear set could be actually off.
Acción
Datascope sent letters to the distributors and end users on 12/7/2005. This communication states that a Datascope Service Representative will conduct and document the corrective action during a visit to the customer.