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.
Sheep blood products may be contaminated with a brucella species (b. ovis).
Acción
Distributors were notified by fax, all customers were notified by fax with a UPS overnight delivery of hard copy of recall letter to same customers. BD International was notified be e-mail.
Distributor fax indicated that BD required their customer lists immediately due to the nature of the recall event. BD received all Distributor customer lists on the same day (7/2/04).
Will monitor the number of consignees non-responding to the recall through sending a letter that contains a form that we ask the end-user to return.
Response forms will be reconciled.
Distribution of the affected lots ceased on 7/1/04.
Customers are asked to discard their 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.
Neuro adapter may fail to engage and adequately clamp to the surgical table, resulting in movement.
Acción
Allen Medical notified the two distributors by telephone on 7/12/04 and 7/16/04. A customer notifcation letter issued requesting return of the device for correction.
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.
Generator failure resulting increase of catheter temperature that could not be controlled by power reduction.
Acción
Customers were instructed to suspend use of the generators with software version 1.033 until they are upgraded with version 1.034B in a letter dated 7/15/2004. Firm issued a second letter on 9/17/04 for a software error discovered in-house during the upgrade. It instructs a workaround solution to prevent unwanted activity of the catheter.
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
Assay,Hybridization And/Or Nucleic Acid Amplification For Detection Of Hepatitis C Rna,Hepatitis C Virus - Product Code MZP
Causa
An increased frequency of 'blue foci' that potentially can cause elevated a450 background in microwell plate wells after the addition of conjugate reagent during pcr detection.
Acción
With respect to U.S distribution, email/letter on 6/24/04 to the local safety officers and general managers stationed at the affiliated distribution center, Roche Diagnostics Corporation of Indianapolis, IN.
With respect to overseas distributors, email/letter on 6/24/04 to the local safety officers and general managers stationed at the affiliated distribution centers. Roche stated that the local safety officer is responsible to communicate the advisory both to the customers/end-users and the regulatory authority of the country.
On July 6, 2004, a Revised Important Product Advice Notice was sent out to affiliates requiring the immediate discontinuation of the use of the affected kits, and destruction of any kits remaining in customers hands.
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
Causa
An increased frequency of 'blue foci' that potentially can cause elevated a450 background in microwell plate wells after the addition of conjugate reagent during pcr detection.
Acción
With respect to U.S distribution, email/letter on 6/24/04 to the local safety officers and general managers stationed at the affiliated distribution center, Roche Diagnostics Corporation of Indianapolis, IN.
With respect to overseas distributors, email/letter on 6/24/04 to the local safety officers and general managers stationed at the affiliated distribution centers. Roche stated that the local safety officer is responsible to communicate the advisory both to the customers/end-users and the regulatory authority of the country.
On July 6, 2004, a Revised Important Product Advice Notice was sent out to affiliates requiring the immediate discontinuation of the use of the affected kits, and destruction of any kits remaining in customers hands.
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 labeled as sterile, but sterility is compromised because some of the packages were not sealed.
Acción
The firm issued a recall letter for some lots on 7/7/04, instructing customers to examine stocks on hand for open packages and to return product without a package seal. The recall was extended to all lots via a second recall letter dated July 29, 2004.
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
Causa
An increased frequency of 'blue foci' that potentially can cause elevated a450 background in microwell plate wells after the addition of conjugate reagent during pcr detection.
Acción
With respect to U.S distribution, email/letter on 6/24/04 to the local safety officers and general managers stationed at the affiliated distribution center, Roche Diagnostics Corporation of Indianapolis, IN.
With respect to overseas distributors, email/letter on 6/24/04 to the local safety officers and general managers stationed at the affiliated distribution centers. Roche stated that the local safety officer is responsible to communicate the advisory both to the customers/end-users and the regulatory authority of the country.
On July 6, 2004, a Revised Important Product Advice Notice was sent out to affiliates requiring the immediate discontinuation of the use of the affected kits, and destruction of any kits remaining in customers hands.
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 increased frequency of 'blue foci' that potentially can cause elevated a450 background in microwell plate wells after the addition of conjugate reagent during pcr detection.
Acción
With respect to U.S distribution, email/letter on 6/24/04 to the local safety officers and general managers stationed at the affiliated distribution center, Roche Diagnostics Corporation of Indianapolis, IN.
With respect to overseas distributors, email/letter on 6/24/04 to the local safety officers and general managers stationed at the affiliated distribution centers. Roche stated that the local safety officer is responsible to communicate the advisory both to the customers/end-users and the regulatory authority of the country.
On July 6, 2004, a Revised Important Product Advice Notice was sent out to affiliates requiring the immediate discontinuation of the use of the affected kits, and destruction of any kits remaining in customers hands.
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
Dna-Reagents, Neisseria - Product Code LSL
Causa
An increased frequency of 'blue foci' that potentially can cause elevated a450 background in microwell plate wells after the addition of conjugate reagent during pcr detection.
Acción
With respect to U.S distribution, email/letter on 6/24/04 to the local safety officers and general managers stationed at the affiliated distribution center, Roche Diagnostics Corporation of Indianapolis, IN.
With respect to overseas distributors, email/letter on 6/24/04 to the local safety officers and general managers stationed at the affiliated distribution centers. Roche stated that the local safety officer is responsible to communicate the advisory both to the customers/end-users and the regulatory authority of the country.
On July 6, 2004, a Revised Important Product Advice Notice was sent out to affiliates requiring the immediate discontinuation of the use of the affected kits, and destruction of any kits remaining in customers hands.
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
Visual, Pregnancy Hcg, Prescription Use - Product Code JHI
Causa
Complaints have been received for axsym total b-hcg reagents lots 17202q100, 17556q100 and 17387q100 failing calibrations.
Acción
Device recall letters dated 7/7/04 were sent to all customers. Customers were instructed to identify if they have used, are currently using, or have inventory of the AxSYM Total B-hCG Reagent lots. Discontinue use of and destroy any remaining inventory of the lots according to their laboratory procedures. Record the quantity currently in their facility that will be destroyed on the attached reply form and fax the form to Abbott at 1-800-777-0051 (U.S. only). Follow their laboratory''s procedure for communicating this issue to the health care providers they serve.
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
Stents, Drains And Dilators For The Biliary Ducts - Product Code FGE
Causa
Ev3 had received customer complaints indicating that the stent device could not be used with an .035' guidewire. an investigation found that 6fr, 135 cm (.018') stent system were labeled as a 120 cm (.035') stent system and that 6fr 120 cm (.035') were labeled as 6fr, 135 cm (.018').
Acción
Send notification letter to direct accounts and an EV3 representative will contact the direct account within the next few days to arrrange for the return of all unused 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
Dialyzer, High Permeability With Or Without Sealed Dialysate System - Product Code KDI
Causa
The accura machine display screen may go blank during patient treatment. there is a potential risk to the patient in that the operator may try to manipulate the controls in response to a blank screen, which could affect the current patient's treatment.
Acción
Baxter sent an Urgent Device Correction letter dated 7/26/04 to the direct accounts on the same date, to the attention of the Hemodialysis Unit and Hospital Administrator. The letters informed the accounts of the potential problem and provided instructions on the procedure to follow in the event the screen goes blank during patient use. Any questions were directed to Baxter Instrument Services at 1-800-553-6898, select prompt 3, option 4.
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 controlling a medical device for patient treatment may malfunction and cause thermal injury to patient.
Acción
Celsion Corporation ceased distribution of the device 6/25/04 and implemented a field correction by company representatives at end user facilities on 6/25/04 consisting of computer clock reset. The firm subsequently notified end users on 7/19/04 by certified letter, which included a warning sticker to be placed on the device control screen. The notification and sticker instructed users not to use the device if there is a possibility of the computer clock transitioning through midnight during the procedure.
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
Stents, Drains And Dilators For The Biliary Ducts - Product Code FGE
Causa
Ev3 had received customer complaints indicating that the stent device could not be used with an .035' guidewire. an investigation found that 6fr, 135 cm (.018') stent system were labeled as a 120 cm (.035') stent system and that 6fr 120 cm (.035') were labeled as 6fr, 135 cm (.018').
Acción
Send notification letter to direct accounts and an EV3 representative will contact the direct account within the next few days to arrrange for the return of all unused 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
Dilator, Vessel, For Percutaneous Catheterization - Product Code DRE
Causa
Firm received a report of an introducer sheath separating from its hub while in the patient. surgery was successful in removal, even though the sheath kept breaking during the attempt.
Acción
Consignees were notified by phone and letter on 7/20/2004.
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, Vessel, For Percutaneous Catheterization - Product Code DRE
Causa
Firm received a report of an introducer sheath separating from its hub while in the patient. surgery was successful in removal, even though the sheath kept breaking during the attempt.
Acción
Consignees were notified by phone and letter on 7/20/2004.
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
Tubes, Vacuum Sample, With Anticoagulant - Product Code GIM
Causa
Coagulation tubes may not have received the proper fill of citrate solution.
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, Vessel, For Percutaneous Catheterization - Product Code DRE
Causa
Firm received a report of an introducer sheath separating from its hub while in the patient. surgery was successful in removal, even though the sheath kept breaking during the attempt.
Acción
Consignees were notified by phone and letter on 7/20/2004.
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 sterile tray label for the model 8540 catheter access port kit may be incorrectly labeled with a model 8551 refill kit label. the outer box of the affected model 8540 catheter access port kit is labeled correctly and the component parts within the sterile tray are the correct components for a model 8540 catheter access port kit. the issue is limited to one lot of product: cs0293.
Acción
The sterile tray label for the Model 8540 Catheter Access Port kit may be incorrectly labeled with a Model 8551 Refill kit label. The outer box of the affected Model 8540 catheter Access Port kit is labeled correctly and the component parts within the sterile tray are the correct components for a Model 8540 Catheter Access Port kit. The issue is limited to one lot of manufactured product: CS0293.
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.
Component defect. metal oxide varister (mov) component of the junction box may short circuit with the potential for device failure.
Acción
The manufacturer notified their distributors of the recall with telephone calls & a letter. The distributors were provided information about the recall and informed of their recall responsibilites.
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
Component, External, Limb, Ankle/Foot - Product Code ISH
Causa
Braking plates of the 3r90 and 3r92 modular knee joint with friction brake may become dislodged which may cause the braking performance of the knee to malfunction.
Acción
The braking plate of the knee may become dislodged, which may cause the braking performance of the knee to malfunction.
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
Campylobacter Spp. - Product Code LQP
Causa
A potential contamination was noted in the conjugate in prospect campylobacter microplate assay. the particulate in the conjugate may cause the dropper tip to become plugged.
Acción
Remel contacted the customer with a letter, requesting a count of the affected lot, and offered replacement of the kits.
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.
The product is labeled as sterile, but sterility is compromised because some of the packages were not sealed.
Acción
The firm issued a recall letter for some lots on 7/7/04, instructing customers to examine stocks on hand for open packages and to return product without a package seal. The recall was extended to all lots via a second recall letter dated July 29, 2004.