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
Implant, Orbital, Extra-Ocular - Product Code HQX
Causa
Lack of sterility assurance.
Acción
The recalling firm issued letters to the accounts requesting the return of the devices.
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
Implant, Orbital, Extra-Ocular - Product Code HQX
Causa
Lack of sterility assurance.
Acción
The recalling firm issued letters to the accounts requesting the return of the devices.
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
Implant, Orbital, Extra-Ocular - Product Code HQX
Causa
Lack of sterility assurance.
Acción
The recalling firm issued letters to the accounts requesting the return of the devices.
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
Implant, Orbital, Extra-Ocular - Product Code HQX
Causa
Lack of sterility assurance.
Acción
The recalling firm issued letters to the accounts requesting the return of the devices.
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
Implant, Orbital, Extra-Ocular - Product Code HQX
Causa
Lack of sterility assurance.
Acción
The recalling firm issued letters to the accounts requesting the return of the devices.
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
Implant, Orbital, Extra-Ocular - Product Code HQX
Causa
Lack of sterility assurance.
Acción
The recalling firm issued letters to the accounts requesting the return of the devices.
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
Gown, Surgical - Product Code FYA
Causa
An indicator inside the package did not change to indicate gowns were sterilized.
Acción
The firm telephoned it's two customers on 6/4/02 and offered to have product returned or provide documentation that the sterlizing indicators were defective, and theoretically the gown packs were sterilized.
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
Gown, Surgical - Product Code FYA
Causa
An indicator inside the package did not change to indicate gowns were sterilized.
Acción
The firm telephoned it's two customers on 6/4/02 and offered to have product returned or provide documentation that the sterlizing indicators were defective, and theoretically the gown packs were sterilized.
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
Gown, Surgical - Product Code FYA
Causa
An indicator inside the package did not change to indicate gowns were sterilized.
Acción
The firm telephoned it's two customers on 6/4/02 and offered to have product returned or provide documentation that the sterlizing indicators were defective, and theoretically the gown packs were sterilized.
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
Gown, Surgical - Product Code FYA
Causa
An indicator inside the package did not change to indicate gowns were sterilized.
Acción
The firm telephoned it's two customers on 6/4/02 and offered to have product returned or provide documentation that the sterlizing indicators were defective, and theoretically the gown packs were sterilized.
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.
Defective energy switch may cause defibrillator to turn off or charge to a different energy level than was selected.
Acción
On 11/25/02 Philips notified customers by letter and requested users to identify the device and use an alternate defibrillator. Philips systems representatives will repair the device in the field. Instructions, titled: 'Risk Mitigation Procedure,' were provided if the unit cannot be pulled from service.
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
unknown device name - Product Code JAJ
Causa
Mislabeling. source calibrated incorrectly, resultant dose rate lower than expected.
Acción
Customers were notified via Advisory Letter followed up with a Recall Letter and Customer Informational Letter on/about January 24, 2002. Customers were advised to discontinue use of the product and return the affected product to Novoste Corp. to be recalibrated to obtain a correct calibration certificate.
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
Apparatus, Exhaust, Surgical - Product Code FYD
Causa
Cap may be cracked and fail, exposing o.R. staff to patient blood, and cause an unexpected loud noise in the o.R.
Acción
Each account was contacted by phone, beginning on December 3, 2002 and advised to refrain from using the units until repairs could be performed. A recall notification letter dated December 6, 2002 was sent to each account informing them of the recall and of plans for repairs.
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 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 data.
Notas adicionales en la data
unknown device name - Product Code 74
Causa
The radio frequency ablation pens contained unreacted epoxy resin which was observed to leak out of the back-end of the device.
Acción
A letter dated November 11, 2002 was sent to the affected consignees who were requested to quarantine any unused pens for retrieval by Medtronic representatives.
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
Culture Media, For Isolation Of Pathogenic Neisseria - Product Code JTY
Causa
Microbiological media may exhibit no growth or reduced colony size of haemophilus species.
Acción
Becton Dickinson notified distributors by fax on 11/18/02 to discard inventory. Firm additionally notified distributors on 11/21/02 to include three additional lots of agar for recall. End users were notified by letter 11/21/02 to discard inventory for replacement, and return reply form.
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
Calculator/Data Processing Module, For Clinical Use - Product Code JQP
Causa
Software development logic defect.
Acción
Notice of the recall was sent to customers by fax on 11/15/2002.
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 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 data.
Notas adicionales en la data
Causa
Air bubbles trapped in the po2 electrode will cause falsely elevated patient test results.
Acción
An urgent device correction letter dated 12/16/02 was sent to each customer. The letter advised of the problem and instructed customers to follow a strict quality control regime to ensure proper electrode performance. Customers were instructed how to automatically lock the affected parameter so that patient results will not be reported if QC performance violates the customer''s programmed rules.
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.
Notas adicionales en la data
Bed, Air Fluidized - Product Code INX
Causa
Battery out-gassing due to battery over charging and/or secondary failure mode of deep-discharge.
Acción
In approximately November 1997 the firm implemented the TransportAir retrograde for all active units.
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
Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days - Product Code FOZ
Causa
Sterility questioned.
Acción
Recalled by letter dated 12/12/02. Customers were informed of the compromised sterility of all lots of the listed products within expiration date, and were requested to destroy all lot numbers of the identified product codes. Baxter will issue their customers credit for the product destroyed.
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
Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days - Product Code FOZ
Causa
Sterility questioned.
Acción
Recalled by letter dated 12/12/02. Customers were informed of the compromised sterility of all lots of the listed products within expiration date, and were requested to destroy all lot numbers of the identified product codes. Baxter will issue their customers credit for the product destroyed.
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
Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days - Product Code FOZ
Causa
Sterility questioned.
Acción
Recalled by letter dated 12/12/02. Customers were informed of the compromised sterility of all lots of the listed products within expiration date, and were requested to destroy all lot numbers of the identified product codes. Baxter will issue their customers credit for the product destroyed.
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 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 data.
Notas adicionales en la data
unknown device name - Product Code 79F
Causa
A gap in the exterior seal may lead to sterility concerns with the interior pouch.
Acción
The sites and/or distributors that received suspect devices were contacted by telephone on 12/11/02 and given instructions on how to return/replace the devices. In addition, a letter dated 12/11/02 was sent to each consignee.
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
Balloon, Epistaxis - Product Code EMX
Causa
Sterility of the device is compromised.
Acción
Ultracell Medical Technologies initiated the recall by fax or mail on 1/8/03. The firm requested return of product . Distributors were requestd to recall to their accounts.
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
Fixing solution bottles are labeled as buffering solution.
Acción
Recall letters dated 12/12/02 were issued via regular mail on 12/18/02 requesting the customer to examine the contents of the kit. If mislabeled bottles are found, they were instructed to return the kit.