French data is current through early September 2018. All of the data comes from L’Agence nationale de sécurité du médicament et des produits de santé (ANSM), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and France.
Notas adicionales en la data
Acción
The batches: 57210Q100 and 59236Q100 of the reagent called: Controls ß-hCG total - reference 9C21-10 (used on the AxSYM or IMx PLCs) of the ABBOTT DIAGNOSTIC company are withdrawn from the market following a risk of obtaining values higher than the specifications announced in the package leaflet which may invalidate the dosing series. This has no impact on patient outcomes since the calibrators and reagents are not affected by this problem.
French data is current through early September 2018. All of the data comes from L’Agence nationale de sécurité du médicament et des produits de santé (ANSM), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and France.
Notas adicionales en la data
Acción
The PSP 8 batch of the reagent called OPUS PSA Modules test - OWZT reference of the company DADE BEHRING SA is withdrawn from the market, following a problem of accuracy leading to overestimated results of the PSA assay. Samples giving a result greater than 4.0 ng / ml should be retested and should be consistent at the clinic.
French data is current through early September 2018. All of the data comes from L’Agence nationale de sécurité du médicament et des produits de santé (ANSM), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and France.
Notas adicionales en la data
Acción
Lot 543502 of the reagent called Protein Protein S - reference OQCE from the company DADE BEHRING SA is withdrawn from the market, after obtaining results on or underestimated in rare and random cases.
Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.
Notas adicionales en la data
UNTIL THIS DATE DOES NOT CONSERT PRODUCT REGISTRATION IN BRAZIL
Causa
The above mentioned kits, kits, and tablets contain anti-sepsis products which may be contaminated by bacteria and / or antiseptic products labeled as sterile and which are not capable of ensuring their sterility. kendall began a recall through correspondence sent on march 24, 2000. the manufacturer provided no information to ecri.
Acción
MAKE SURE THAT YOU HAVE RECEIVED THE LETTER OF MARCH 24, 2000 AND KENDALL LABELS. IDENTIFY AND COLLECT ANY AFFECTED PRODUCT FROM YOUR INVENTORY. PUT THE LABELS ON ANY DAMAGED PRODUCT AND COLLECT / DISPOSE ANY ANTI-SEPTIC PRODUCT CLINIC OF THE KITS. FOR FURTHER INFORMATION, CONTACT KENDALL'S LOCAL CONSUMER SERVICE OR TELEPHONE 1 (508) 261-8000 IN THE UNITED STATES.
Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.
Notas adicionales en la data
UNTIL THIS DATE DOES NOT CONSERT PRODUCT REGISTRATION IN BRAZIL
Causa
The above mentioned kits, kits, and tablets contain anti-sepsis products which may be contaminated by bacteria and / or antiseptic products labeled as sterile and which are not capable of ensuring their sterility. kendall began a recall through correspondence sent on march 24, 2000. the manufacturer provided no information to ecri.
Acción
MAKE SURE THAT YOU HAVE RECEIVED THE LETTER OF MARCH 24, 2000 AND KENDALL LABELS. IDENTIFY AND COLLECT ANY AFFECTED PRODUCT FROM YOUR INVENTORY. PUT THE LABELS ON ANY DAMAGED PRODUCT AND COLLECT / DISPOSE ANY ANTI-SEPTIC PRODUCT CLINIC OF THE KITS. FOR FURTHER INFORMATION, CONTACT KENDALL'S LOCAL CONSUMER SERVICE OR TELEPHONE 1 (508) 261-8000 IN THE UNITED STATES.
Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.
Notas adicionales en la data
UNTIL THIS DATE DOES NOT CONSERT PRODUCT REGISTRATION IN BRAZIL
Causa
The above mentioned kits, kits, and tablets contain anti-sepsis products which may be contaminated by bacteria and / or antiseptic products labeled as sterile and which are not capable of ensuring their sterility. kendall began a recall through correspondence sent on march 24, 2000. the manufacturer provided no information to ecri.
Acción
MAKE SURE THAT YOU HAVE RECEIVED THE LETTER OF MARCH 24, 2000 AND KENDALL LABELS. IDENTIFY AND COLLECT ANY AFFECTED PRODUCT FROM YOUR INVENTORY. PUT THE LABELS ON ANY DAMAGED PRODUCT AND COLLECT / DISPOSE ANY ANTI-SEPTIC PRODUCT CLINIC OF THE KITS. FOR FURTHER INFORMATION, CONTACT KENDALL'S LOCAL CONSUMER SERVICE OR TELEPHONE 1 (508) 261-8000 IN THE UNITED STATES.
Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.
Notas adicionales en la data
UNTIL THIS DATE DOES NOT CONSERT PRODUCT REGISTRATION IN BRAZIL
Causa
The above mentioned kits, kits, and tablets contain anti-sepsis products which may be contaminated by bacteria and / or antiseptic products labeled as sterile and which are not capable of ensuring their sterility. kendall began a recall through correspondence sent on march 24, 2000. the manufacturer provided no information to ecri.
Acción
MAKE SURE THAT YOU HAVE RECEIVED THE LETTER OF MARCH 24, 2000 AND KENDALL LABELS. IDENTIFY AND COLLECT ANY AFFECTED PRODUCT FROM YOUR INVENTORY. PUT THE LABELS ON ANY DAMAGED PRODUCT AND COLLECT / DISPOSE ANY ANTI-SEPTIC PRODUCT CLINIC OF THE KITS. FOR FURTHER INFORMATION, CONTACT KENDALL'S LOCAL CONSUMER SERVICE OR TELEPHONE 1 (508) 261-8000 IN THE UNITED STATES.
French data is current through early September 2018. All of the data comes from L’Agence nationale de sécurité du médicament et des produits de santé (ANSM), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and France.
Notas adicionales en la data
Acción
Lot 529632 of the reagent called PFA 100-Collagen test cartridge / ADP reference B 4170-21 of the company DADE BEHRING SA is withdrawn from the market following the alteration of the membrane of some cartridges resulting in the appearance of abnormal results (Time d elongated occlusion or absence of occlusion). This reagent is used when an abnormal result - indicative of platelet dysfunction - is obtained with the PFA 100-Collagen Cartridge / PPE Reagent; it makes it possible to detect platelet dysfunctions related to taking acetylsalicylic acid.
French data is current through early September 2018. All of the data comes from L’Agence nationale de sécurité du médicament et des produits de santé (ANSM), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and France.
Notas adicionales en la data
Acción
The director general. Vu. Book VIII of the Public Health Code, and in particular Articles L.793-1 and L.793-5-I. Vu. the eight reports of materiovigilance received between October 26, 1999 and February 28, 2000. Seen. the expert report of 8 February 2000. Seen. Mail No. 20000823 dated March 1, 2000, sent to the manufacturer for comments. Considering. that the reports of materiovigilance report nine opacifications of intraocular lenses Orion IFP3D6 manufactured, put on the market and distributed by the company Eurocrystal from March 17, 1999, intervened within 3 to 22 months after their implantation. Considering. to date, the origin of these opacifications, which have led to a decrease in the visual acuity of the patients, could not be determined. Considering. that these opacifications required the explantation of six lenses, and that this operation puts patients at risk. Considering. whereas, therefore, pending the determination of the causes of the opacifications and in the interest of public health, the implantation of these lenses should be suspended. DECIDE. ARTICLE 1e. : The manufacture, placing on the market, distribution, export and use of Orion IFP3D6 intraocular lenses manufactured by Eurocrystal - 3, avenue de l'Europe - Campus 2A - 31400 TOULOUSE, are suspended for a period of six months from the date of publication of this Decision. The Director of Medical Device Evaluation and the Director of Inspection and Facilities are responsible, each for his own part, for the implementation of this decision, which will be published in the Official Journal. of the French Republic. Done at Saint-Denis, April 10, 2000.
French data is current through early September 2018. All of the data comes from L’Agence nationale de sécurité du médicament et des produits de santé (ANSM), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and France.
Notas adicionales en la data
Acción
The director general. Vu. Book VIII of the Public Health Code, and in particular Articles L.793-1 and L.793-5-I. Vu. the three reports of materiovigilance received between 26 September 1999 and 7 February 2000. Seen. the expert report of 8 February 2000. Seen. Mail No. 20000822 dated March 1, 2000, sent to the manufacturer for comments. Considering. that the reports of materiovigilance report four opacifications of Acryflex SC60B-0UV intraocular lenses manufactured and put on the market by the company Medical Developmental Research from December 3, 1997 to March 17, 1999, occurred within 12 to 24 months after their implantation. Considering. to date, the origin of these opacifications, which have led to a decrease in the visual acuity of the patients, could not be determined. Considering. that these opacifications required the explantation of a lens, and that this operation puts patients at risk. Considering. whereas it is therefore appropriate, pending the determination of the causes of the opacifications and in the interest of public health, to suspend the implantation of these lenses. DECIDE. ARTICLE 1. : The distribution, importation and use of Acryflex SC60B-0UV intraocular lenses manufactured by Medical Developmental Research - 2451 Enterprise Road - Clearwater - Florida 33763 - USA, is suspended for a period of 6 months, starting at the date of publication of this Decision. ARTICLE The Director of Medical Device Evaluation and the Director of Inspection and Facilities are responsible, each for his own part, for the implementation of this decision, which will be published in the Official Journal. of the French Republic. Dated at Saint-Denis on April 10, 2000.
Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.
Notas adicionales en la data
UNTIL THIS DATE DOES NOT CONSERT PRODUCT REGISTRATION IN BRAZIL
Causa
Water may evaporate from polyvinyl chloride bag on the heating gloves mentioned after long storage periods. this evaporation results in an increase in salt concentrations, which could increase the temperature of the sleeve and cause burns in the patient. aquarius medical has not received any complaint or report of injury caused by use of the above gloves mentioned. the manufacturer started a removal by correspondence dated 12 april 2000.
Acción
MAKE SURE THAT YOU HAVE RECEIVED THE CORRESPONDENCE OF 12 APRIL 2000 AND THE AQUARIUS MEDICAL PRODUCTION INFORMATION FORM. IDENTIFY AND ISOLE ANY PRODUCT AFFECTED FROM YOUR INVENTORY. DISCLAIMS THE USE AND DISTRIBUTION OF ANY DEFECTIVE PRODUCT, CONSIDER IT TO BE USED AND DESTRUCTES IT IN ACCORDANCE WITH APPLICABLE LAWS, REGULATIONS AND DECREES, FEDERAL, STATE AND LOCAL. PLEASE FILL OUT THE PRODUCTION INFORMATION FORM AND SEND TO AQUARIUS MEDICAL BY MAIL AT THE ABOVE ADDRESS OR BY FAX AT 1 (480) 991-4335. IF YOU PREFER TO RETURN THE DEFECTIVE PRODUCT, CONTACT YOUR LOCAL REPRESENTATIVE OR DIRECTLY WITH AQUARIUS MEDICAL BY PHONE 1 (480) 991-1818 TO RETURNED GOODS AUTHORIZATION NUMBER. FOR FURTHER INFORMATION, PLEASE CONTACT CHRISTINA FLEMING, AQUARIUS MEDICAL, BY PHONE1 (480) 991-1818, RAMAL 219.
French data is current through early September 2018. All of the data comes from L’Agence nationale de sécurité du médicament et des produits de santé (ANSM), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and France.
Notas adicionales en la data
Acción
Lot 738182101 - lot of cartridge 000805-0 of the reagent called VIDAS CA 125 II - reference 30426 of the company BIOMÉRIEUX SA is withdrawn from the market following a change in the time of the performances of the reagent resulting in an overestimation of the results (currently order of 6U / ml max.) and a value out of control specifications.
French data is current through early September 2018. All of the data comes from L’Agence nationale de sécurité du médicament et des produits de santé (ANSM), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and France.
Notas adicionales en la data
Acción
Lot 55552Q100 of the reagent called IMx hCG calibrators - reference 3A63-01 of the company ABBOTT DIAGNOSTIC is withdrawn from the market following a lowering of the signal resulting in an increase in the values of the controls (sometimes beyond the specifications) and an increase in the values of the patient samples (approximately 20% for pure samples and 30% for diluted samples).
French data is current through early September 2018. All of the data comes from L’Agence nationale de sécurité du médicament et des produits de santé (ANSM), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and France.
Notas adicionales en la data
Acción
Lots 064999, 131100, 140700, 170300, 171600, 180700, 224799, 240400, 280900 of the reagent called SECURICARD 1 pocket-reference 109010224; batches 205199, 215199 of the reagent called SECURICARD 3 bags -reference 109010124; batches 240400, 294399 of the reagent called PHYSIOCARD 1 pocket-reference 109012124 and batch 024499 of the reagent called PHYSIOCARD 3 pockets -reference 109012224 of the company INSTITUT JACQUES BOY are withdrawn from the market, following a weakening of the anti-A antibody of these devices (cards) pre-transfusion control, causing a decrease in the intensity of the agglutination reaction leading to a misinterpretation of the test.
French data is current through early September 2018. All of the data comes from L’Agence nationale de sécurité du médicament et des produits de santé (ANSM), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and France.
Notas adicionales en la data
Acción
Lot 60 of the reagent called Vitros Immunodiagnostic Products / IgM anti-VHA standard (reference 1372101) from the company ORTHO CLINICAL DIAGNOSTICS is withdrawn from the market due to a risk of lowering the signal that may cause a rise in the values of the controls beyond the specifications and elevation of values of patient samples. As a result, from the date of expiration of the calibration curve that has been validated by control values in accordance with those expected after use of the standard control protocol, lot 60 of the reagent called Vitros Immunodiagnostic Products / cartridge IgM anti-HAV reagent (reference 8450124), mandatory for use with the former, is also withdrawn from the market.
French data is current through early September 2018. All of the data comes from L’Agence nationale de sécurité du médicament et des produits de santé (ANSM), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and France.
Notas adicionales en la data
Acción
The batch 134 of the reagent called Vitros Immunodiagnostic Products / Estradiol reagent cartridge (reference 8552630), and, consequently, the batch 134 of the reagent called Vitros Immunodiagnostic Products / Estadiol Standards (reference 1318930), obligatorily used with the first, of ORTHO CLINICAL DIAGNOSTICS are withdrawn from the market due to a risk of overestimation (3 SD ie 15-35%) of estradiol concentrations in patient samples and controls.
Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.
Notas adicionales en la data
UNTIL THIS DATE DOES NOT CONSERT PRODUCT REGISTRATION IN BRAZIL
Causa
There is the possibility of corrosion of the mechanical relay that activates the energy fall alarm in the respirators mentioned. the manufacturer began a correction by correspondence sent on june 2, 2000.
Acción
MAKE SURE YOU HAVE RECEIVED THE CORRESPONDENCE SENT ON JUNE 2, 2000, BY BEAR MEDICAL SYSTEMS. IDENTIFY ANY AFFECTED PRODUCT IN YOUR INVENTORY. FOR FURTHER INFORMATION, PLEASE CONTACT YOUR LOCAL REPRESENTATIVE OR DIRECTLY WITH THE BEAR MEDICAL SYSTEMS DEPARTMENT OF TECHNICAL SERVICES BY PHONE 1 (760) 778-7300 IN THE UNITED STATES.
Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.
Notas adicionales en la data
UNTIL THIS DATE DOES NOT CONSERT PRODUCT REGISTRATION IN BRAZIL
Causa
There is the possibility of corrosion of the mechanical relay that activates the energy fall alarm in the respirators mentioned. the manufacturer began a correction by correspondence sent on june 2, 2000.
Acción
MAKE SURE YOU HAVE RECEIVED THE CORRESPONDENCE SENT ON JUNE 2, 2000, BY BEAR MEDICAL SYSTEMS. IDENTIFY ANY AFFECTED PRODUCT IN YOUR INVENTORY. FOR FURTHER INFORMATION, CONTACT YOUR LOCAL REPRESENTATIVE OR DIRECTLY WITH THE BEAR MEDICAL SYSTEMS DEPARTMENT OF TECHNICAL SERVICES BY PHONE 1 (760) 778-7300 IN THE UNITED STATES
Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.
Notas adicionales en la data
UNTIL THIS DATE DOES NOT CONSERT PRODUCT REGISTRATION IN BRAZIL
Causa
There is the possibility of corrosion of the mechanical relay that activates the energy fall alarm in the respirators mentioned. the manufacturer began a correction by correspondence sent on june 2, 2000.
Acción
MAKE SURE YOU HAVE RECEIVED THE CORRESPONDENCE SENT ON JUNE 2, 2000, BY BEAR MEDICAL SYSTEMS. IDENTIFY ANY AFFECTED PRODUCT IN YOUR INVENTORY. FOR FURTHER INFORMATION, CONTACT YOUR LOCAL REPRESENTATIVE OR DIRECTLY WITH THE BEAR MEDICAL SYSTEMS DEPARTMENT OF TECHNICAL SERVICES BY PHONE 1 (760) 778-7300 IN THE UNITED STATES
Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.
Notas adicionales en la data
UNTIL THIS DATE DOES NOT CONSERT PRODUCT REGISTRATION IN BRAZIL
Causa
There is the possibility of corrosion of the mechanical relay that activates the energy fall alarm in the respirators mentioned. the manufacturer began a correction by correspondence sent on june 2, 2000.
Acción
MAKE SURE YOU HAVE RECEIVED THE CORRESPONDENCE SENT ON JUNE 2, 2000, BY BEAR MEDICAL SYSTEMS. IDENTIFY ANY AFFECTED PRODUCT IN YOUR INVENTORY. FOR FURTHER INFORMATION, PLEASE CONTACT YOUR LOCAL REPRESENTATIVE OR DIRECTLY WITH THE BEAR MEDICAL SYSTEMS DEPARTMENT OF TECHNICAL SERVICES BY PHONE 1 (760) 778-7300 IN THE UNITED STATES.
Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.
Notas adicionales en la data
01/30/2002 - The company informs that STENT VASCULAR PERIFERICO VASCUCOIL was not imported by Medtronic Comercial Ltda, or by any other authorized distributor, and consequently there is no unit of this product in Brazil.
Causa
The aforementioned sharp-tip reusable handles can be detached from the stent-graft catheter system. the distributor initiated a mailing removal dated june 13, 2000.
Acción
Make sure that you have received the June 13, 2000 correspondence from Medtronic AVE. Identify and collect any affected product from your inventory. For product return information, please contact your Medtronic AVE representative or mail to the address listed above.
Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.
Notas adicionales en la data
UNTIL THIS DATE DOES NOT CONSERT PRODUCT REGISTRATION IN BRAZIL
Causa
An ecri member hospital reported that the defibrillation machines mentioned developed fissures and lasks through their borders as they were reterproofed in the time.
Acción
ECRI MAKES THE FOLLOWING RECOMMENDATIONS: (1) NOTIFY EMPLOYEES ABOUT THE PROBLEM, REMEMBER THAT THESE DEFIBRILLATION OPERATORS HAVE LIFE OF APPROXIMATELY 200 STERILIZATIONS AND ARE UNDER WARRANTY FOR 1 YEAR. IN ADDITION, ENSURE THAT THE DEFIBRILLATION ACTUATORS MADE BEFORE 1O. OF MARCH OF 1999 MAY BE MORE SUSCEPTIBLE TO FISSURES AND LASKS THAT MOST RECENT MODELS. (2) FOLLOW THE MANUFACTURER'S STERILIZATION GUIDELINES. (3) REPORT TO ANVISA AND THE MANUFACTURER IN CASE OF FISSURES AND LASKS APPEAR WITHIN THE WARRANTY PERIOD OF THE DEFIBRILLATION ACTUATOR SETS MADE AFTER 1O. OF MARCH 1999. (4) REPAIR ANY STERILIZABLE DEFIBRILLATION ACTUATOR SO THAT THEY REPEAT FISSURES OR LASKS AFTER REHOSTERILIZATION. (5) IF THE POSSIBILITY OF A PATIENT IS NECESSARY TO NEED DEFIBRILLATION DURING A PROCEDURE, CONSIDER PLACING DISPOSABLE ADHESIVES IN THE PATIENT BEFORE THE BEGINNING OF THE OPERATION BEFORE USING EXTERNAL DEFIBRILLATION PARTS. THIS WILL REDUCE THE NUMBER OF STERILIZATIONS OF THE DEFIBRILLATION ACTUATORS.
Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.
Notas adicionales en la data
UNTIL THIS DATE DOES NOT CONSERT PRODUCT REGISTRATION IN BRAZIL
Causa
The above mentioned nerve locator can operate intermittently, which may result in a lack of perception of stimulus when the nervous tissue is really touched by the stimulator. this false-negative response may be interpreted as the absence of nervous tissue. the manufacturer started a removal by correspondence dated of june 19, 2000.
Acción
MAKE SURE THAT YOU HAVE RECEIVED THE DATED CORRESPONDENCE OF JUNE 19, 2000 AND THE MEDTRONIC XOMED SURGICAL PRODUCTS CHECKLIST. IDENTIFY AND ISOLE ANY PRODUCT AFFECTED FROM YOUR INVENTORY USING THE CHECKLIST. RETURN THE PRODUCT AFFECTED FOR MEDTRONIC XOMED SURGICAL PRODUCTS AT THE ADDRESS REFERRED TO. MEDTRONIC XOMED SURGICAL PRODUCTS WILL ISSUE A CREDIT OR SEND A NERVE STIMULATOR / LOCATOR FOR ANY AFFECTED PRODUCT RETURNED. WHEN YOU SEND THE AFFECTED PRODUCT, CLEARLY IDENTIFY THE EXPORT PACKAGING PARTY ON THE OUTSIDE OF THE SHIPPING PACKAGE, THE PRODUCT RETURN AUTHORIZATION NUMBER SPECIFIED IN THE NOTIFICATION LETTER AND INCLUDE A COPY OF THE CORRESPONDENCE DATE OF JUNE 19, 2000 AND THE CHECKLIST FOR RECEIPT OF THE CREDIT. FILL IN THE CHECKLIST AND FAX FOR MEDTRONIC XOMED SURGICAL PRODUCTS 1 (904) 296-2386. FOR FURTHER INFORMATION, PLEASE CONTACT YOUR LOCAL REPRESENTATIVE OR DIRECTLY WITH MEDTRONIC XOMED SURGICAL PRODUCTS CONSUMER SERVICE BY PHONE 1 (904) 296-9600 IN THE UNITED STATES.
Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.
Notas adicionales en la data
UNTIL THIS DATE DOES NOT CONSERT PRODUCT REGISTRATION IN BRAZIL
Causa
The aforementioned test discs have been labeled as a record of susceptibility tests on the cephalothionein, since the boxes contain titers of susceptibility to vancomycin. the distributor started a recall by dated correspondence of june 27, 2000. the company has provided no information to ecri.
Acción
MAKE SURE THAT YOU HAVE RECEIVED THE CORRESPONDENCE OF JUNE 27, 2000 FROM REMEL. IDENTIFY AND ISOLE ANY PRODUCT AFFECTED FROM YOUR INVENTORY. FOR FURTHER INFORMATION, PLEASE CONTACT YOUR LOCAL REMEL REPRESENTATIVE
French data is current through early September 2018. All of the data comes from L’Agence nationale de sécurité du médicament et des produits de santé (ANSM), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and France.
Notas adicionales en la data
Acción
Lot AA0025 of the reagent called Dimension Apolipoprotein A1 reference 7528003 from the company DADE BEHRING SA is withdrawn from the market following the mention of an incorrect expiry date on the labeling (February 2001), not corresponding to the actual expiry date coded by the lot number (25.01.2000). The reagent performances, verified by the manufacturer, being in conformity with those expected, the assays obtained since the 25.01.2000 are not questioned.