Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
Notas adicionales en la data
Causa
On tuesday, november 28, 2017, the therapeutics goods administration (tga) notified boston scientific of tga’s decision to remove two transvaginally implanted boston scientific mesh products from the australian register of therapeutic goods (artg), effective january 4, 2018.The tga believes there is currently a lack of adequate scientific evidence for it to be satisfied that the risks to patients are outweighed by the benefits of these devices. further information can be found on the tga website.As a result boston scientific is recalling all uphold lite with capio slim and solyx single incision sling system products from the australian market.No other boston scientific devices are affected by this recall.
Acción
Boston Scientific is advising hospitals to immediately discontinue use of and segregate affected product. The devices should be stored in a secure location for return to Boston Scientific. Instructions for product return are provided on the Customer Letter issued to affected customers.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
Notas adicionales en la data
Causa
The reason for this recall is that the device could cause a patient overpressure situation without any visual or auditory indication or warning from the device. if specific conditions occur, the affected unit could create an overpressure which is transient and reversible, requiring intervention from medical staff. if the device were to fail, the surgical attendants, anaesthetist or doctor would see an over -distension of the pneumoperitoneum or difficulty in patient breathing. the manufacturer has received one adverse event report overseas where the device caused an overpressure situation.
Acción
Conmed is advising users to immediately check their facility for the affected unit(s) and to contact Conmed, who will in turn organise collection of the affected unit and return of the corrected unit. If necessary, Conmed will provide a loaner device whilst the product correction is undertaken.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
Notas adicionales en la data
Causa
The backup mechanism designed to detect and identify a failed temperature sensor is not functioning as expected, resulting in the potential for excessive heating if the sensor should fail. although no patient or user injury has occurred as a result of this reported complaint, excessive heating of the endoeye distal end could result in patient or user injury.
Acción
Olympus is advising the customers to inspect stock and quarantine the affected units prior to their return to the sponsor. Upon receiving the affected units, Olympus will perform a short term correction by disabling the "fog-free" function and return the corrected units back to the customers for routine use. A final permanent fix involving a hardware upgrade will restore full functionality of the device is expected to be performed in 2016.
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
vascular embolization device - Product Code HGC
Causa
The product appears to have premature degradation of the pgla coating on the matrix coil.
Acción
US consignees were notified by letter sent by Federal Express on October 19, 2010. Customers out of the United States were notified by Federal Express if possible and by personal delivery by locally assigned sales representatives as needed.
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
vascular embolization device - Product Code HGC
Causa
The product appears to have premature degradation of the pgla coating on the matrix coil.
Acción
US consignees were notified by letter sent by Federal Express on October 19, 2010. Customers out of the United States were notified by Federal Express if possible and by personal delivery by locally assigned sales representatives as needed.
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
vascular embolization device - Product Code HGC
Causa
The product appears to have premature degradation of the pgla coating on the matrix coil.
Acción
US consignees were notified by letter sent by Federal Express on October 19, 2010. Customers out of the United States were notified by Federal Express if possible and by personal delivery by locally assigned sales representatives as needed.
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
vascular embolization device - Product Code HGC
Causa
The product appears to have premature degradation of the pgla coating on the matrix coil.
Acción
US consignees were notified by letter sent by Federal Express on October 19, 2010. Customers out of the United States were notified by Federal Express if possible and by personal delivery by locally assigned sales representatives as needed.
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
vascular embolization device - Product Code HGC
Causa
The product appears to have premature degradation of the pgla coating on the matrix coil.
Acción
US consignees were notified by letter sent by Federal Express on October 19, 2010. Customers out of the United States were notified by Federal Express if possible and by personal delivery by locally assigned sales representatives as needed.
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
vascular embolization device - Product Code HGC
Causa
The product appears to have premature degradation of the pgla coating on the matrix coil.
Acción
US consignees were notified by letter sent by Federal Express on October 19, 2010. Customers out of the United States were notified by Federal Express if possible and by personal delivery by locally assigned sales representatives as needed.
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
Clamp, Uterine - Product Code HGC
Causa
The product appears to have premature degradation of the pgla coating on the matrix coil.
Acción
US consignees were notified by letter sent by Federal Express on October 19, 2010. Customers out of the United States were notified by Federal Express if possible and by personal delivery by locally assigned sales representatives as needed.
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
vascular embolization device - Product Code HGC
Causa
The product appears to have premature degradation of the pgla coating on the matrix coil.
Acción
US consignees were notified by letter sent by Federal Express on October 19, 2010. Customers out of the United States were notified by Federal Express if possible and by personal delivery by locally assigned sales representatives as needed.
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
vascular embolization device - Product Code HGC
Causa
The product appears to have premature degradation of the pgla coating on the matrix coil.
Acción
US consignees were notified by letter sent by Federal Express on October 19, 2010. Customers out of the United States were notified by Federal Express if possible and by personal delivery by locally assigned sales representatives as needed.
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
vascular embolization device - Product Code HGC
Causa
The product appears to have premature degradation of the pgla coating on the matrix coil.
Acción
US consignees were notified by letter sent by Federal Express on October 19, 2010. Customers out of the United States were notified by Federal Express if possible and by personal delivery by locally assigned sales representatives as needed.
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
tubal occlusion device - Product Code HGB
Causa
The sterile pouch seal may fail to remain intact during handling rendering the hulka clip non-sterile.
Acción
Richard Wolfe sent recall letters dated October 16, 2009 to the direct accounts via certified mail on the same date. The accounts were informed that the lot of Hulka clips did not meet their sterile seal burst test requirements, and that the sterile seal may fail to remain intact during handling, resulting in the clips becoming contaminated or non-sterile. They were instructed to inspect their inventory for the affected lot, quarantine any product found and call Richard Wolf at 800-323-9653, ext 225 or 380 to arrange for the return of the affected product for replacement. The accounts were also requested to complete and return the enclosed response form to Richard Wolf, even if they do not have any of the affected lot in stock.
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
Assisted Reproduction Needle - Product Code MQE
Causa
Smiths medical international became aware that certain lots of wallace oocyte recovery sets have a damaged needle tip.
Acción
The recall was initiated by Smiths Medical on October 22, 2008 with the forwarding a recall notification to Irvine Scientific. Smiths Medical International sells the products to Irvine Scientific for distribution in the U.S. Irvine Scientific is the U.S. Agent.
Irvine Scientific issued an Urgent Field Safety Notice Letter, dated 10/22/2008, with attached fax-back Customer Response form to their customers via US Postal service beginning on October 24, 2008. Irvine Scientific requested their customers to complete an inventory summary on the Customer Response form and contact the firm to arrange for the return of any remaining product in their inventory 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.
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.
Expiration date for sterility; the 5 year dating could not be validated/supported for sterility assurance.
Acción
All customers were contacted by telephone starting 9/13/2007. They were asked to return all Tucker family of catheters and all Morton IUI catheters that are on the shelves. A UPS call tag was sent to each customer to facilitate the return of the products. A follow up Urgent Device Recall letter was sent to all customers on 10/9/2007 reminding them to return all outstanding inventory when the UPS call tag arrives.
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.
Expiration date for sterility; the 5 year dating could not be validated/supported for sterility assurance.
Acción
All customers were contacted by telephone starting 9/13/2007. They were asked to return all Tucker family of catheters and all Morton IUI catheters that are on the shelves. A UPS call tag was sent to each customer to facilitate the return of the products. A follow up Urgent Device Recall letter was sent to all customers on 10/9/2007 reminding them to return all outstanding inventory when the UPS call tag arrives.
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.
Expiration date for sterility; the 5 year dating could not be validated/supported for sterility assurance.
Acción
All customers were contacted by telephone starting 9/13/2007. They were asked to return all Tucker family of catheters and all Morton IUI catheters that are on the shelves. A UPS call tag was sent to each customer to facilitate the return of the products. A follow up Urgent Device Recall letter was sent to all customers on 10/9/2007 reminding them to return all outstanding inventory when the UPS call tag arrives.
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.
Expiration date for sterility; the 5 year dating could not be validated/supported for sterility assurance.
Acción
All customers were contacted by telephone starting 9/13/2007. They were asked to return all Tucker family of catheters and all Morton IUI catheters that are on the shelves. A UPS call tag was sent to each customer to facilitate the return of the products. A follow up Urgent Device Recall letter was sent to all customers on 10/9/2007 reminding them to return all outstanding inventory when the UPS call tag arrives.
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.
Expiration date for sterility; the 5 year dating could not be validated/supported for sterility assurance.
Acción
All customers were contacted by telephone starting 9/13/2007. They were asked to return all Tucker family of catheters and all Morton IUI catheters that are on the shelves. A UPS call tag was sent to each customer to facilitate the return of the products. A follow up Urgent Device Recall letter was sent to all customers on 10/9/2007 reminding them to return all outstanding inventory when the UPS call tag arrives.
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.
Expiration date for sterility; the 5 year dating could not be validated/supported for sterility assurance.
Acción
All customers were contacted by telephone starting 9/13/2007. They were asked to return all Tucker family of catheters and all Morton IUI catheters that are on the shelves. A UPS call tag was sent to each customer to facilitate the return of the products. A follow up Urgent Device Recall letter was sent to all customers on 10/9/2007 reminding them to return all outstanding inventory when the UPS call tag arrives.
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
Condom - Product Code HIS
Causa
Condoms fail the water leak test and package integrity.
Acción
Global Protection Corp. recalled product by email on 9/11/07
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
Birthing Bed - Product Code HDD
Causa
Brake failure: the brakes may not hold or lock properly.
Acción
Hill-Rom notified consignees via Urgent Medical Device Correction letter dated 9/6/07. The letter instructed facilities to continue using the beds if they pass a test of the brake mechanism; and a Hill-Rom representative will contact the facility to schedule a replacement of the detent mechanism and adjustment of the casters.
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
System, Monitoring, Perinatal - Product Code HGM
Causa
Potential for incorrect weight to be displayed.
Acción
On 10/13/04 the firm sent letters to customers advising of the error, and that software to correct the problem will be released the end of October. Service personnel will install new software.