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
Calculator/Data Processing Module, For Clinical Use - Product Code JQP
Causa
Motor driver boards may contain wrong type of microchip which does not have obstruction detection feature.
Acción
Product Corrective Action letter was sent the week of 9/29/2003 by US MAIL with a fax back card.
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.
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
Stent, Coronary - Product Code MAF
Causa
A packaging defect may compromise the device's sterility barrier.
Acción
The firm initially mailed letters to accounts on 9/26/2003 instructing them to quarantine the indicated products pending a visit from Cordis inspectors. This mailing was followed up by one of two methods: 1) some accounts were visited by a Cordis Inspector who inspected the product at the account, and removed any potentially discrepant product and put a green dot on product which passed inspection and could be used, and 2) the remainder of the accounts were visited by Cordis Sales Representatives, in which case all product was removed from the account and returned to Cordis for inspection. Product passing Cordis inspection had a green dot put on the label and was redistributed. A representative of the account, and the inspector or sales representative signed an Acknowledgement form which in kept by Cordsi. This inspection process was completed by January 22, 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
Wire, Guide, Catheter - Product Code DQX
Causa
The product has the potential to break during withdrawal process.
Acción
On 9/22/03, the firm issued letters via Federal Express to all its direct consignees, informing them of the affected devices and providing instructions on the recall.
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
Biopsy Needle - Product Code FCG
Causa
There is a possibility that the affected devices would not capture a biopsy during a procedure.
Acción
On April 24, 2002 all field representatives were notified via email and all international accounts via fax. Consignees were advised to quarantine all affected product in their possession and to give the product to their Territory Manager for return. Consignees were urged to complete the bottom portion of the letter and return it via the Territory Manager to Wilson-Cook Medical.
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
Audible alarm occurs before aspiration potentially resulting in operator injury or results assigned to wrong patient for stat samples.
Acción
The firm issued a letter on 09/30/2003 notifying customers of the Device Correction and provided instructions to disable the audible alert. Abbott Diagnostics will correct this issue in the next revision of the AEROSET System Software.
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.
Firm received complaints of tingling or static shock sensation to end users caused by forcing the output connector into its receptacle misaligned. the misalignment causes additional voltage to appear on the patient probe.
Acción
Misonix, Inc. notified the sole direct consignee, Byron Medical Inc., of the "Corrective Action" by letter on 8/13/03. On 9/17/03, Byron Medical Inc. notified the end users by letter, and provided instructions for proper assembly and warning labels to be affixed to the 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
Electrode, Ph, Stomach - Product Code FFT
Causa
Pouch containing pediatric probes was labeled as containing adult probes.
Acción
The 3 consignees were notified by telephone on 09/24/2003, followed by a 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
Calculator/Data Processing Module, For Clinical Use - Product Code JQP
Causa
Software defect. when orders are modified before the roche cobas integra query for a specimen, the sample id locks.
Acción
Firm has issued notifcation to all affected 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.
X-ray tube arm and collimator fell and fractured patient's ribs.
Acción
An initial safety alert was sent to sites on 7/29/2003 to pre-announce repairs and advise them to not use the equipment. A second safety alert was sent on 8/11/03 to confirm repair dates. Repairs were completed 8/19,2003.
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.
Excessive cleaning and resterilization cause cracking and crazing of device causing the device to malfunction during use.
Acción
Letters were sent to surgeons and hospital operating room supervisors in mid-May 2002 which included the following information:
It is imperative that hospitals regularly and thoroughly inspect all testing instruments for indications of wear and degredation. And, CarboMedics is in the process of re-issuing suggested maintenance and sterilization guidlines.
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.
Potential for display to go blank due to an electrical component that may fail due to mechanical shock of vibration of the defibrillator.
Acción
Letters dated April 2004 were sent to customers on 4/6/04. The letter explains that a service representative will visit the customer and check the capacitor.
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
Stent, Coronary - Product Code MAF
Causa
A packaging defect may compromise the device's sterility barrier.
Acción
The firm initially mailed letters to accounts on 9/26/2003 instructing them to quarantine the indicated products pending a visit from Cordis inspectors. This mailing was followed up by one of two methods: 1) some accounts were visited by a Cordis Inspector who inspected the product at the account, and removed any potentially discrepant product and put a green dot on product which passed inspection and could be used, and 2) the remainder of the accounts were visited by Cordis Sales Representatives, in which case all product was removed from the account and returned to Cordis for inspection. Product passing Cordis inspection had a green dot put on the label and was redistributed. A representative of the account, and the inspector or sales representative signed an Acknowledgement form which in kept by Cordsi. This inspection process was completed by January 22, 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.
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.
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.
Compalints of acetabular shell disassociating with the bone.
Acción
The firm called and issued letters on September 30, 2003 informing physicians of a complaint received. The letter requested that the physicians discontinue use of the device until and investigation could be conducted. On 03/8/2004 the firm issued a letter to Zimmer distributors to return all 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.
Typographical error in the operator manual. in chapter 11 of the mtx/mtx ii operator manual, the numerical range for the warning flag is shown as 00-99. the correct numerical range is 0-99. the 'list of error and warning' chart shows a numerical range representing the codes 00-9. the correct numerical range for the first ten error/warning codes are 0-9.
Acción
Consignees were notified by letter on September 29, 2003.
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.
Potential for batteries to malfunction due to battery cell rupture.
Acción
On 4/2/04 the firm initiated telephone contacts to customers to determine if the customer potentially has suspect battery. If so, the customer will be faxed a letter describing how to remove the battery to check for the code date. If customer confirms they have suspect battery, a new battery will be shipped to 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.
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 KPF--
Causa
There are software anomalies present that may increase the possibility of a medication error if the dialysis clinic software is used to track, record, or coordinate the administration of medications.
Acción
Baxter sent Urgent Device Correction letters dated 4/12/04 to the attention of the Dialysis Unit Administrator. Separate letters were sent to the Renalsoft customers and to the Renal Software Suite customers. The letters described the software anomalies associated with the software and provided interim workaround instructions until permanent corrective actions to these anomalies can be identified.
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 KPF--
Causa
There are software anomalies present that may increase the possibility of a medication error if the dialysis clinic software is used to track, record, or coordinate the administration of medications.
Acción
Baxter sent Urgent Device Correction letters dated 4/12/04 to the attention of the Dialysis Unit Administrator. Separate letters were sent to the Renalsoft customers and to the Renal Software Suite customers. The letters described the software anomalies associated with the software and provided interim workaround instructions until permanent corrective actions to these anomalies can be identified.