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
Medication Administration - Product Code NXS
Causa
Medications prescribed for one patient were printed on the medication administration record (mar) of another patient.
Acción
Current customers were mailed a Recall Letter January 31,2007 explaining the issue and informing the customers of an upcoming CyberMED Version 2.1 maintenance software release to correct the potential issue. A fax-back Acknowledgement of Receipt form was sent with the Recall 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
Vitrectomy Cutter - Product Code HQE
Causa
The cutter probe tip breaks during use.
Acción
On 2/12/07, express mail letters were addressed to operating room supervisors to notify them of the recall. Additional E-mail notifications were issued on 2/14/07 to doctors and letters were addressed to them on 2/20/07 to make them aware of the recall, although they do not directly receive the product. The communications instructed them to not use the affected product and to return it, along with the business reply 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
Vitrectomy Cutter - Product Code HQE
Causa
The cutter probe tip breaks during use.
Acción
On 2/12/07, express mail letters were addressed to operating room supervisors to notify them of the recall. Additional E-mail notifications were issued on 2/14/07 to doctors and letters were addressed to them on 2/20/07 to make them aware of the recall, although they do not directly receive the product. The communications instructed them to not use the affected product and to return it, along with the business reply 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
Heating Pad - Product Code IRT
Causa
Heating pads may have a loose electrical connection, which could result in excessive heat being generated that poses a risk of patient burns, fire, and property damage.
Acción
Press release issued on 2/9/07 instructing consumers to return the product to store of purchase or Homedics. Retail stores notified via recall letter issued on 2/9/07. Retail stores are being instructed to accept returns and to post placards to notify customers of 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
Hemoperfusion filter - Product Code FLD
Causa
Lack of sterility assurance based on lack of sterility validation for labeled sterilization directions.
Acción
The firm notified its consignees of the problem and the recall via letter (priority mail with delivery confirmation)dated 01/19/2007 beginning on 01/19/2007. This letter requested that the consignee cease the use of this product and contact the recalling firm for return instructions. Follow-up with non-reponders will be made by facsimile.
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
Hemoperfusion filter - Product Code FLD
Causa
Lack of sterility assurance based on lack of sterility validation for labeled sterilization directions.
Acción
The firm notified its consignees of the problem and the recall via letter (priority mail with delivery confirmation)dated 01/19/2007 beginning on 01/19/2007. This letter requested that the consignee cease the use of this product and contact the recalling firm for return instructions. Follow-up with non-reponders will be made by facsimile.
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
Hemoperfusion filter - Product Code FLD
Causa
Lack of sterility assurance based on lack of sterility validation for labeled sterilization directions.
Acción
The firm notified its consignees of the problem and the recall via letter (priority mail with delivery confirmation)dated 01/19/2007 beginning on 01/19/2007. This letter requested that the consignee cease the use of this product and contact the recalling firm for return instructions. Follow-up with non-reponders will be made by facsimile.
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
Hemoperfusion filter - Product Code FLD
Causa
Lack of sterility assurance based on lack of sterility validation for labeled sterilization directions.
Acción
The firm notified its consignees of the problem and the recall via letter (priority mail with delivery confirmation)dated 01/19/2007 beginning on 01/19/2007. This letter requested that the consignee cease the use of this product and contact the recalling firm for return instructions. Follow-up with non-reponders will be made by facsimile.
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
Thermal endometrial ablation system - Product Code MNB
Causa
Defective integrated circuit board could result in loss of the system pump and patient injury (hot fluid 90 degree c into uterus) if in use during the recirculation/heating phase of treatment.
Acción
Boston Scientific notiifed accounts by letter dated January 24, 2007 via federal Express Mail. Accounts were requested to examine inventory, remove and 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.
Notas adicionales en la data
Thermal endometrial ablation system - Product Code MNB
Causa
Defective integrated circuit board could result in loss of the system pump and patient injury (hot fluid 90 degree c into uterus) if in use during the recirculation/heating phase of treatment.
Acción
Boston Scientific notiifed accounts by letter dated January 24, 2007 via federal Express Mail. Accounts were requested to examine inventory, remove and 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.
Notas adicionales en la data
Thermal endometrial ablation system - Product Code MNB
Causa
Defective integrated circuit board could result in loss of the system pump and patient injury (hot fluid 90 degree c into uterus) if in use during the recirculation/heating phase of treatment.
Acción
Boston Scientific notiifed accounts by letter dated January 24, 2007 via federal Express Mail. Accounts were requested to examine inventory, remove and 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.
Notas adicionales en la data
Thermal endometrial ablation system - Product Code MNB
Causa
Defective integrated circuit board could result in loss of the system pump and patient injury (hot fluid 90 degree c into uterus) if in use during the recirculation/heating phase of treatment.
Acción
Boston Scientific notiifed accounts by letter dated January 24, 2007 via federal Express Mail. Accounts were requested to examine inventory, remove and 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.
Notas adicionales en la data
Thermal endometrial ablation system - Product Code MNB
Causa
Defective integrated circuit board could result in loss of the system pump and patient injury (hot fluid 90 degree c into uterus) if in use during the recirculation/heating phase of treatment.
Acción
Boston Scientific notiifed accounts by letter dated January 24, 2007 via federal Express Mail. Accounts were requested to examine inventory, remove and 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.
Notas adicionales en la data
Surface electrodes - Product Code GZX
Causa
A labeling discrepancy was internally identified for the surface electrode component of ref 8263210 accuguide emg injection needle, 30g x 25mm. the outside box label correctly indicates 'content: 5 sterile injection needles and 10 non-sterile surface electrodes'; however, the pouches for the 10 surface electrodes inside the box are incorrectly labeled as 'sterile'.
Acción
Each consignee contacted via telephone 01/22/2007, and then sent a follow-up fax letter 02/02/2007, which explained the issue, and the options for dispositioning any product that they still had in stock.
Since firm has determined that the risk of keeping and using these devices is negligible to no risk, as they are intended to be and typically used in a non-sterile manner, the firm is offering the consignees the option to keep their devices or have them replaced.
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.
Six lots of u-clip removal tools, catalog rem1860fw were incorrectly assembled. the nose cone attachment to the body of the removal tool does not contain sufficient adhesive which can cause the nose to separate from the body of the device.
Acción
Customers to be notified via a letter on 2/8/07. The letter will explain the situation and requests that the impacted product be returned to Medtronic for disposal. The customer will be requested to complete a "Recall Certificate" acknowledging the receipt of this information.
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
Hemodialysis machine - Product Code KDI
Causa
Under certain conditions, * an excessive amount of anticoagulant may be infused into the patient. (* interruption of a self-test by an alarm and obstruction of the access lines).
Acción
Customers were notified by letter on 12/19/2006. They were told that Gambro would schedule the required upgrades to their equipment and not to use the current syringe for delivering anticoagulant.
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
Blood Glucose Test Strips - Product Code NBW
Causa
Counterfeit product (manufacturer unknown).
Acción
A recall notification was sent on February 1, 2007 via first class mail to all 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
drug delivery catheters - Product Code KRA
Causa
Ekos corporation received three reports that distal radiopaque marker bands on the endowave drug delivery catheter became detached from the catheter during use and remained in the patient.
Acción
On 2/9/07 the firm faxed and sent via certified return receipt an URGENT: Device Recall letter to their consignees. The letters requested to immediately examine stock and segregate all recalled products. In addition, the firm''s representatives will contact, via phone or visit, each of the consignees. Product is to be returned to the firm.
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
Perfusion System - Product Code DTW
Causa
The hand crank may crack in the bearing/shaft area due to a manufacturing defect. (note: some of the hand cranks subject to this recall were shipped as replacements for hand cranks recalled in the summer of 2006.).
Acción
Consignees were notified by phone between 1/12/07 and 2/23/07 and informed replacement hand cranks would be shipped.