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
Motor, Drill, Pneumatic - Product Code HBB
Causa
Lubricant leaking from motor after sterilization causing bleed-through sterilization wrap and/or excess lubricant in instrument case.
Acción
Recall letter was sent on 11/11/2002 to all consignees requesting that the consignee contact the Medtronic Neurologic Technologies sales representative for 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 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 LID
Causa
The check valve in the patient line may stick in the closed position.
Acción
Integra notified their customers via recall letter and reply form on 12/16/2002 via FedEx.
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
Retractor, Self-Retaining, For Neurosurgery - Product Code GZT
Causa
The component was manufactured with an insufficient weld that could break during use.
Acción
The firm contacted their accounts by email and telephone on 2/26/2003.
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.
Notas adicionales en la data
Motor, Drill, Electric - Product Code HBC
Causa
Faulty component causing a malfunction which would unexpectedly shutdown the drill system and user may not be able to restart.
Acción
A recall notification letter was mailed to domestic consignees and faxed to international consignees on April 23, 2003. The letter requests 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
Stimulator, Nerve, Transcutaneous, For Pain Relief - Product Code GZJ
Causa
If there was a short, excessive heat could have been generated in the transformer due to the use of the wrong fuse.
Acción
Recall letters dated May 21, 2003 requested that consignees return the product and a response form to the firm. Distributors were requested to recall the product from their 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.
Notas adicionales en la data
Endoscope, Neurological - Product Code GWG
Causa
Non sterile device is labeled sterile.
Acción
The firm notified their customers via a field correction letter dated June 17, 2003. Instructions given are to sterilize the unit prior to use. A EBI field representative will be visiting to replace the boxes.
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
Endoscope, Neurological - Product Code GWG
Causa
Size mix-up. 13 cm product may be labeled as 21.6 mm and visaversa.
Acción
Firm sales representatives will contact customers and hand deliver the recall notice.
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
Endoscope, Neurological - Product Code GWG
Causa
Size mix-up. 13 cm product may be labeled as 21.6 mm and visaversa.
Acción
Firm sales representatives will contact customers and hand deliver the recall notice.
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
Dura Substitute - Product Code GXQ
Causa
The tamper-evident shrink band may fall off causing the user uncertainty whether the product was opened and is still sterile.
Acción
Letter was sent 12/19/2003 to the 19 hospitals were the product was distributed.
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
Shunt, Central Nervous System And Components - Product Code JXG
Causa
Mislabeled - product actually single valve.
Acción
The recalling firm faxed copies of recall letters to the hospitals informing them of the problem and the need to return 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
Catheter, Ventricular - Product Code HCA
Causa
Drainage tips absent from catheter tip.
Acción
Codman telephoned direct customers by telphone on 3/11/04. Accounts were requested to return 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.
Implied claims (extremes of compulsive or addictive behavior) are outside the scope of clearance for the device.
Acción
The recalling firm issued a letter to their customers dated 4/8/04 informing them of the problem. The letter explained that the manual was changed due to unacceptable text. The consignees were instructed to change the user manuals prior to shipping.
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.
Skull pins, which fractured below device specifications during qc testing, were distributed.
Acción
The firm notified their customers of the recall via facsimile on 6/29/2004. The faxed notification was followed by a hard copy of the recall letter sent via overnight mail. The letter instructs the customers to immediate cease using of the affected product; complete the Fax Back form provided with the recall notice; and return the affected product to Integra for 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.
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
Motor, Drill, Pneumatic - Product Code HBB
Causa
Reduced plastic thickness of lubricant/diffuser cartidge can crack under pressure causing leakage of lubricant as visible mist (appearance of smoke).
Acción
The firm initiated the recall by letter on November 3, 2004 asking consignees to return unused 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.
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
Motor, Drill, Pneumatic - Product Code HBB
Causa
Softer hose increases the propensity for outer exhaust hose to kink or become occluded as a result of clamping. complaints of hose rupture/burst have been reported.
Acción
The firm initiated the recall via letter on November 11, 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.
A burn injury was sustained by a patient that did not follow the directions for use and also slept while charging the unit.
Acción
Firm has notified all consignees and thier clinicians to provide them with the labeling addenda. Patient notices were sent by FedEx or by US Mail and clinicians were faxed the notice.
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
Full-Montage Standard Electroencephalograph - Product Code GWQ
Causa
Under specific conditions, the housing of the pulse oximeter contected to the amplifier can become excessively warm causing a burn upon contact with skin.
Acción
The firm initiated the recall on February 24, 2005 via letter with return response post 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.
Notas adicionales en la data
Full-Montage Standard Electroencephalograph - Product Code GWQ
Causa
Under specific conditions, the housing of the pulse oximeter contected to the amplifier can become excessively warm causing a burn upon contact with skin.
Acción
The firm initiated the recall on February 24, 2005 via letter with return response post card.