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
Bur, Ear, Nose And Throat - Product Code EQJ
Causa
Product packaging pouches may be open thereby compomising the sterile barrier.
Acción
A recall notification letter and Effectiveness Response Form were Federal Expressed Overnight Delivery to the attention of the Risk Manager at each consignee on 1/25/2003. Consignees were requested to respond and return recalled product to Medtronic Xomed in Jacksonville, FL. or they can destroy them and request credit.
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
Ear Wick - Product Code KCN
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
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
Ear Wick - Product Code KCN
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
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
Ear Wick - Product Code KCN
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
Ear Wick - Product Code KCN
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
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
Ear Wick - Product Code KCN
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
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
Syringe, Ent - Product Code KCP
Causa
Finished products were not sterilized.
Acción
Medegen has notified all direct accounts by certified mail on 4/30/03.
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
Curette, Adenoid - Product Code KBJ
Causa
The box label indicates that the product is a size 2 whereas a size 4 was packed inside.
Acción
A Recall notification letter was mailed to each hospital account on January 29, 2004 for each type of device they received which was under recall explaining the error and asking the accounts to remove recalled product from inventory, fax them the response sheet and to return the products.
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
Prosthesis, Larynx (Stents And Keels) - Product Code FWN
Causa
The tracheal stent may collapse resulting in blockage of the air passage because the stents were not properly coated with the polyurethane material to the very end of the stent.
Acción
Consignees were notified by telephone on 4/22/2004.
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
Implant, Cochlear - Product Code MCM
Causa
Battery pack may overheat and cause patient burns.
Acción
Notification letters were sent to all users and affiliates on July 27, 2004. Initially customers were informed that they will receive a retrofit kit. Firm decided to actually recall the battery packs and sent recall letters on August 10, 2004. All Auria Battery Packs are to be returned per instructions in the recall letters. Firm rerecalled powerpaks that had been repaired since FDA review has found that repairs are not sufficent to address all potential adverse events concieveable. The latest recall letter was sent May 11-12, 2005
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 - Product Code ETN
Causa
The firm received six reports of tubes with wires 'out of channel' two of which involved injuried patients. in one case in germany it was reported that the patient had soreness of the throat and was discharged after four days. in the next case the patient had a tracheal wound. it was not clear what caused the wound.
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
Tester, Auditory Impedance - Product Code ETY
Causa
Internal investigation revealed that preamp cable assemblies in the device had not been properly tested, which could lead to potential shock to users.
Acción
The firm plans to provide corrections via removal/replacement of the affected units directly to end users in the U.S. and work with distributors to perform removal and correction abroad.
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
Aids, speech training for the hearing impaired (ac-powered and patient-contact) - Product Code LEZ
Causa
Siemens became aware of an issue where an infant or child could open the tamper resistant battery compartment of the siemens prisma 2k hearing aid under certain unintended use conditions.
Acción
Siemens sent a notice letter to affected customers in 7/2005 and 12/2005. The letter identified the affected product, problem and actions to be taken. Siemens will install an additional security measure to affected product at no charge. For questions contact your Sales Representative at 800-766-4500.
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
Instrument, Ent Manual Surgical - Product Code LRC
Causa
Device sterility may be compromised as evidenced by a loss of package integrity.
Acción
On 1/20/06 the firm initiated the recall and its notification was via letters explaining the reason for the recall and requesting the product be returned.
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
Cochlear Implant - Product Code MCM
Causa
Certain hires 90k cochlear implants could fail as a result of elevated moisture levels. the unimplanted hires 90k implants listed are being removed from the market. patients are to be followed for signs of device failure: intermittent function, complete loss of sound, sudden discomfort, pain, noise, or popping.
Acción
The recall was initiated on 03/08/06. In North America, the clinician notification letters were distributed by fax. For other regions, an Advanced Bionics representative and/or distributor are providing notification to the affected clinicians. As part of the clinician notification process, each center was provided with a list of their affected devices. Customers were given a list of HiRes 90K implants with feedthrus from Supplier B that were shipped to their clinic and are not yet registered with Advanced Bionics. Customers were asked to return the implants listed in the attachment to Advanced Bionics according to the instructions. Customers were told not to implant any of the devices on the list. Customers were told that implants manufactured wth feedthrus from Supplier A will be delivered quickly to minimize disruptions to their schedule. Customers will be contacted through Advanced Bionics Customer Service within 48 hours to arrange retrieval of implants manufactured with feedthrus from Supplier B and replacement with implants manufactured with feedthrus from Supplier A.
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
Cochlear Implant - Product Code MCM
Causa
Certain hires 90k cochlear implants could fail as a result of elevated moisture levels. the unimplanted hires 90k implants listed are being removed from the market. patients are to be followed for signs of device failure: intermittent function, complete loss of sound, sudden discomfort, pain, noise, or popping.
Acción
The recall was initiated on 03/08/06. In North America, the clinician notification letters were distributed by fax. For other regions, an Advanced Bionics representative and/or distributor are providing notification to the affected clinicians. As part of the clinician notification process, each center was provided with a list of their affected devices. Customers were given a list of HiRes 90K implants with feedthrus from Supplier B that were shipped to their clinic and are not yet registered with Advanced Bionics. Customers were asked to return the implants listed in the attachment to Advanced Bionics according to the instructions. Customers were told not to implant any of the devices on the list. Customers were told that implants manufactured wth feedthrus from Supplier A will be delivered quickly to minimize disruptions to their schedule. Customers will be contacted through Advanced Bionics Customer Service within 48 hours to arrange retrieval of implants manufactured with feedthrus from Supplier B and replacement with implants manufactured with feedthrus from Supplier A.
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
Nostril retainers - Product Code LYA
Causa
Device contains a trace amount of amine via introduction through an intermediate supplied by a third party raw material.
Acción
Consignees were contacted by phone for product return and with a follow up in letter dated 07/12/2006.
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
Laryngectomy Tube - Product Code KAC
Causa
The label incorrectly states the outer diameter of the tube is 20.0 mm when it is actually 12.0 mm.
Acción
Consignees were notified via recall letter dated 12/15/06. Distributors were requested to provide the firm with final user name and address information so that they could notify them of the recall. The firm is advising users that they can either return the product for replacement or continue to use it now that they are aware of the labeling error.
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
Surgical ENT Drill - Product Code ERL
Causa
Incorrect sterilization process --the operating manual for the product contains an incorrect statement regarding the sterilization of the autolube foot control. the manual states that the product can withstand eto sterilization, but there is no data to support this process.
Acción
Anspach issued an Urgent Device Correction letter on 11/27/06, to all manual holders advising them of the error and requested that they update the manual with the corrected instructions. A reply receipt confirming notification was included.