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
ventilation accessories - Product Code NPF
Causa
Foreign material: glass fragments may present in the plastic bag material used to ship components.
Acción
The recalling firm issued a Recall Notification dated 10/18/07 to its customers. Replacement products were to be sent.
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
Dialysis system - Product Code KDI
Causa
Kinked tubing on hemodialysis device may cause hemolysis.
Acción
On September 10, 2007, the firm sent an Advisory Notice to all consignees alerting them that a kink in the tubing can result in physical hemolysis. The firm included with the Notice a Quick Reference Guide that provides drawing of the proper installation of the Phoenix and describes how to prevent bloodline kinking. A customer reply form was also included. The firm is in the process of making labeling changes that will be released with the updated software revisions.
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
Preformed Crowns - Product Code ELZ
Causa
Mislabeled: unitek stainless steel permanent molar crowns were placed in packaging which incorrectly identified the product as unitek stainless steel primary molar crowns.
Acción
3M ESPE Dental Products initially contacted Distributors and Doctors on 10/22/07 through telephone calls, and sent a Device Recall letter via Fed Ex - Overnight on 10/22/07.
The letter informed the users that Unitek Stainless Steel Permanent Crowns Lot # P060928, Product Code 900321 may be mislabeled as Unitek Stainless Steel Primary Molar Crowns. Users were asked to stop using and/or distributing the product and contact ESPE Dental Products at 1-800-237-1650 to initiate product return and replacement.
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.
False negative results when used to test serum samples (as compared to plasma samples).
Acción
On September 19, 2007, Beckman Coulter mailed to its consignees an Urgent Product Corrective Action Letter informing them that the affected lots of the product were giving false negative results when used to test serum samples (as compared to plasma samples). The letter instructed consignees to discontinue using the affected lots of the product, and to re-test using an EDTA plasma sample if there was any discordance between the results of the serum sample (if it was obtained using an affected lot of the product) as compared with the clinical presentaion of the patient and the results of other diagnostic tests. The letter also instructed consignees to return, within 10 days, the Response Sheet .
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
Autonomic Nerve Stimulator - Product Code LYJ
Causa
Screen freezes-- the dell x5 handheld pc screen will freeze caused due to incompatibility between the microsoft 2002 os and the model dell x5 handheld computer. once frozen, the handheld device becomes non-responsive to user input.
Acción
Cyberonics sent an initial notification (Important Safety Alert) to physicians via Certified Mail on 10/01/07. Letter notified physicians that the Dell X5 handheld computer screen will freeze following an interrogation. Once frozen the handheld device becomes non-responsive to user inputs. The firm informed the user that in the event that the computer becomes non-responsive, the user has two options, 1) Reinitialized the flash memory and, 2) Perform a software reset of the handheld computer. A second notification addressing the approval and addition of labeling was sent to physicians on 11/15/07. Physicians were asked to respond to both letters via an enclosed response card, acknowledging receipt of the notification. Additional information will be posted at www.VNStherapy.com.
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
Acetabular Inserter Instrument - Product Code LXH
Causa
The instrument will not lock onto the impactor handle; the device was distributed without assembly of the bal seal component.
Acción
Distributors were notified of the device defect by letter (Urgent Field Correction Notice) dated 10/18/07, and provided with assembly instructions and parts, and instructed to make corrections at consignee 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
Acetabular Inserter Instrument - Product Code LXH
Causa
The instrument will not lock onto the impactor handle; the device was distributed without assembly of the bal seal component.
Acción
Distributors were notified of the device defect by letter (Urgent Field Correction Notice) dated 10/18/07, and provided with assembly instructions and parts, and instructed to make corrections at consignee 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
Acetabular Inserter Instrument - Product Code LXH
Causa
The instrument will not lock onto the impactor handle; the device was distributed without assembly of the bal seal component.
Acción
Distributors were notified of the device defect by letter (Urgent Field Correction Notice) dated 10/18/07, and provided with assembly instructions and parts, and instructed to make corrections at consignee 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
Acetabular Inserter Instrument - Product Code LXH
Causa
The instrument will not lock onto the impactor handle; the device was distributed without assembly of the bal seal component.
Acción
Distributors were notified of the device defect by letter (Urgent Field Correction Notice) dated 10/18/07, and provided with assembly instructions and parts, and instructed to make corrections at consignee 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
Acetabular Inserter Instrument - Product Code LXH
Causa
The instrument will not lock onto the impactor handle; the device was distributed without assembly of the bal seal component.
Acción
Distributors were notified of the device defect by letter (Urgent Field Correction Notice) dated 10/18/07, and provided with assembly instructions and parts, and instructed to make corrections at consignee 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
Acetabular Inserter Instrument - Product Code LXH
Causa
The instrument will not lock onto the impactor handle; the device was distributed without assembly of the bal seal component.
Acción
Distributors were notified of the device defect by letter (Urgent Field Correction Notice) dated 10/18/07, and provided with assembly instructions and parts, and instructed to make corrections at consignee 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.
Incorrect results -- through evaluation of stability, abbott have found a decrease in the calibrator a to f span with these reagents lots, which may produce the following results: - printed error code "span less than min span" - controls out of range. when a control is out of range, patient results should not be reported.
Acción
Letters were sent to customers by Federal Express Priority mail on October 26, 2007. Two unique customer letters were sent. One letter was delivered to TDxlTDxFLx customers who received shipment oflots 5ll87Q100 and 51189QI00 and a second letter was delivered to AxSYM customers who received lots 53190QI00 and 53190QI01. Two letters were written because the actions required by the customer differ for the AxSYM and TDxlTDxFLx platforms. TDx/TDxFLx customers
" Customer Letter (Product Recall)
" Customer Reply Form
AxSYM Customers
" Customer Letter (Product Correction)
" Customer Reply Form
The Customers were instructed the following:
TDx/TDxFLx Gentamacin Reagents
" Discontinue use of and destroy TDx/TDxFLx reagent lots 51187Q 1 00 and 51189QI00.
" Document the number of kits discarded for your records. Abbott will provide reimbursement for your destroyed kits.
" If customers have forwarded any of the affected lots to another laboratory, to provide the laboratory with a copy of the communication.
AxSYM Gentamicin Reagents
" Revise the expiration date for lots 53190Ql 00 and 53190QI0l from 4/12/08 to 11/30/2007.
" Run each level of control with each AxSYM Gentamicin sample or batch of samples.
" If customers have forwarded any of the affected lots to another laboratory, to provide the laboratory with a copy of the communication.
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.
Incorrect results -- through evaluation of stability, abbott have found a decrease in the calibrator a to f span with these reagents lots, which may produce the following results: - printed error code "span less than min span" - controls out of range. when a control is out of range, patient results should not be reported.
Acción
Letters were sent to customers by Federal Express Priority mail on October 26, 2007. Two unique customer letters were sent. One letter was delivered to TDxlTDxFLx customers who received shipment oflots 5ll87Q100 and 51189QI00 and a second letter was delivered to AxSYM customers who received lots 53190QI00 and 53190QI01. Two letters were written because the actions required by the customer differ for the AxSYM and TDxlTDxFLx platforms. TDx/TDxFLx customers
" Customer Letter (Product Recall)
" Customer Reply Form
AxSYM Customers
" Customer Letter (Product Correction)
" Customer Reply Form
The Customers were instructed the following:
TDx/TDxFLx Gentamacin Reagents
" Discontinue use of and destroy TDx/TDxFLx reagent lots 51187Q 1 00 and 51189QI00.
" Document the number of kits discarded for your records. Abbott will provide reimbursement for your destroyed kits.
" If customers have forwarded any of the affected lots to another laboratory, to provide the laboratory with a copy of the communication.
AxSYM Gentamicin Reagents
" Revise the expiration date for lots 53190Ql 00 and 53190QI0l from 4/12/08 to 11/30/2007.
" Run each level of control with each AxSYM Gentamicin sample or batch of samples.
" If customers have forwarded any of the affected lots to another laboratory, to provide the laboratory with a copy of the communication.
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
Enzyme Immunoassay, Gentamicin - Product Code LCD
Causa
Incorrect results -- through evaluation of stability, abbott have found a decrease in the calibrator a to f span with these reagents lots, which may produce the following results: - printed error code "span less than min span" - controls out of range. when a control is out of range, patient results should not be reported.
Acción
Letters were sent to customers by Federal Express Priority mail on October 26, 2007. Two unique customer letters were sent. One letter was delivered to TDxlTDxFLx customers who received shipment oflots 5ll87Q100 and 51189QI00 and a second letter was delivered to AxSYM customers who received lots 53190QI00 and 53190QI01. Two letters were written because the actions required by the customer differ for the AxSYM and TDxlTDxFLx platforms. TDx/TDxFLx customers
" Customer Letter (Product Recall)
" Customer Reply Form
AxSYM Customers
" Customer Letter (Product Correction)
" Customer Reply Form
The Customers were instructed the following:
TDx/TDxFLx Gentamacin Reagents
" Discontinue use of and destroy TDx/TDxFLx reagent lots 51187Q 1 00 and 51189QI00.
" Document the number of kits discarded for your records. Abbott will provide reimbursement for your destroyed kits.
" If customers have forwarded any of the affected lots to another laboratory, to provide the laboratory with a copy of the communication.
AxSYM Gentamicin Reagents
" Revise the expiration date for lots 53190Ql 00 and 53190QI0l from 4/12/08 to 11/30/2007.
" Run each level of control with each AxSYM Gentamicin sample or batch of samples.
" If customers have forwarded any of the affected lots to another laboratory, to provide the laboratory with a copy of the communication.
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
Surgical Tray - Product Code LRP
Causa
Incorrect needle size - some of the kits contain a 1 inch 21g needle instead of the 1-1/2 inch 21g needle specified on the kit label.
Acción
An Urgent Product Recall Notice was sent on October 25, 2007 to Distributors, Distributors customers, and all third party consignee. The letter provided information concerning the product recall, and requested removal of all product inventory. A product return form requesting information on products still in the facility was enclosed. A Tri-State Representative will be in contact regarding retrieval 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.
Notas adicionales en la data
Surgical Disposable Instrument - Product Code KDC
Causa
Incorrect needle size - some of the kits contain a 1 inch 21g needle instead of the 1-1/2 inch 21 needle specified on the kit label.
Acción
An Urgent Product Recall Notice was sent on October 25, 2007 to Distributors, Distributors customers, and all third party consignee. The letter provided information concerning the product recall, and requested removal of all product inventory. A product return form requesting information on products still in the facility was enclosed. A Tri-State Representative will be in contact regarding retrieval 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.
Notas adicionales en la data
Hip Prosthesis Component - Product Code KWL
Causa
Incorrect part: device may have an incorrect locking ring assembled with the uhr bipolar head.
Acción
Stryker sent Urgent Product Hold letters to US branches/agencies and hospitals on October 26, 2007 advising them to quarantine the product from these lots, and Urgent Product Recall letters on November 2, 2007 advising them to return the devices to Stryker. International distributors were sent an advisory on November 6, 2007.
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
Hip Prosthesis Component - Product Code KWL
Causa
Incorrect part: device may have an incorrect locking ring assembled with the uhr bipolar head.
Acción
Stryker sent Urgent Product Hold letters to US branches/agencies and hospitals on October 26, 2007 advising them to quarantine the product from these lots, and Urgent Product Recall letters on November 2, 2007 advising them to return the devices to Stryker. International distributors were sent an advisory on November 6, 2007.
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
Hip Prosthesis Component - Product Code KWL
Causa
Incorrect part: device may have an incorrect locking ring assembled with the uhr bipolar head.
Acción
Stryker sent Urgent Product Hold letters to US branches/agencies and hospitals on October 26, 2007 advising them to quarantine the product from these lots, and Urgent Product Recall letters on November 2, 2007 advising them to return the devices to Stryker. International distributors were sent an advisory on November 6, 2007.