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
Mistuned headpiece - advanced bionics recently became aware of a tuning issue with some platinum series and s-series
headpieces shipped from may 2007 through april 2008. tuning refers to the process through which the headpiece's communication
frequency is adjusted to match that of the internal device. potential clinical
symptoms include:
-no lock
-intermittent lock
-implant locks, but cann.
Acción
Advanced Bionics is notifying clinicians of this situation so that they can provide
appropriate clinical management. The notification letter sent to clinicians in the
United States was sent via FedEx so that delivery information could be confirmed. The letter advises that Advanced Bionics recently became aware of a tuning issue with some Platinum Series and S-Series headpieces shipped from May 2007 through April 2008. Auria and Harmony headpieces are not
affected by this issue. Tuning refers to the process through which the headpiece's communication frequency is adjusted to match that of the internal device.
Since discovery of this issue firm has conducted an extensive technical analysis showing that the use of these headpieces does not pose any safety risk to the patient. While there has been no increase in the
number of headpiece-related complaints, firm advises of the potential clinical
symptoms:
-No lock
-Intermittent lock
-Implant locks, but cannot measure impedances
-Reduction in battery life, primarily for C1 patients with thick flaps.
Per the letter, as long as the system maintains lock, there is no degradation in sound quality or
stimulation. Further, the impact on battery life for CII and HiRes 90K patients is minimal.
Medical professionals are advised that If they have any patients who display any of these clinical symptoms that they attribute to an affected
headpiece, to advise the patient to contact Advanced Bionics Customer Service at 877-244-9541 and they will send them a replacement promptly.
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
Vestibular analysis apparatus - Product Code LXV
Causa
The firm distributed an unapproved medical device.
Acción
On July 9, 2008 the firm issued a Device Recall Notification letter to its consignees by letter on July 9, 2008 by US mail. The recall notification was directed to the end users of the units requesting the return of all units. In the event of a non-responding consignee, the firm will make additional efforts to contact the individual via certified return receipt mail or other form of notification requiring a signature. Follow up direct contact through telephone will also be used. If you have any questions contact Eric Johnson at (615) 202-9370.
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.
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.
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.
Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). this could result in an injury to the patient due to product contamination or loss of sterility condition.
Acción
Customed Inc. sent a Recall Notification letter dated June 3, 2014 via email and followed by letter to all affected customers. The letter identified the affected products, problem and actions to be taken. The letter informed customers if the affected products are in their inventory to: 1. Remove products from sale (quarantine them) and cease distribution. 2. Complete and return the enclosed acknowledgement form to Customed Inc .Recall Coordinator. Affected products should be returned to Customed Inc for credit.
Customers with questions were instructed to contact Customed Inc. Recall Coordinator at 1-787-801-0100 Ext. 7540
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.
Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). this could result in an injury to the patient due to product contamination or loss of sterility condition.
Acción
Customed Inc. sent a Recall Notification letter dated June 3, 2014 via email and followed by letter to all affected customers. The letter identified the affected products, problem and actions to be taken. The letter informed customers if the affected products are in their inventory to: 1. Remove products from sale (quarantine them) and cease distribution. 2. Complete and return the enclosed acknowledgement form to Customed Inc .Recall Coordinator. Affected products should be returned to Customed Inc for credit.
Customers with questions were instructed to contact Customed Inc. Recall Coordinator at 1-787-801-0100 Ext. 7540
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.
Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). this could result in an injury to the patient due to product contamination or loss of sterility condition.
Acción
Customed Inc. sent a Recall Notification letter dated June 3, 2014 via email and followed by letter to all affected customers. The letter identified the affected products, problem and actions to be taken. The letter informed customers if the affected products are in their inventory to: 1. Remove products from sale (quarantine them) and cease distribution. 2. Complete and return the enclosed acknowledgement form to Customed Inc .Recall Coordinator. Affected products should be returned to Customed Inc for credit.
Customers with questions were instructed to contact Customed Inc. Recall Coordinator at 1-787-801-0100 Ext. 7540
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.
Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). this could result in an injury to the patient due to product contamination or loss of sterility condition.
Acción
Customed Inc. sent a Recall Notification letter dated June 3, 2014 via email and followed by letter to all affected customers. The letter identified the affected products, problem and actions to be taken. The letter informed customers if the affected products are in their inventory to: 1. Remove products from sale (quarantine them) and cease distribution. 2. Complete and return the enclosed acknowledgement form to Customed Inc .Recall Coordinator. Affected products should be returned to Customed Inc for credit.
Customers with questions were instructed to contact Customed Inc. Recall Coordinator at 1-787-801-0100 Ext. 7540
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
Tube, tympanostomy - Product Code ETD
Causa
One lot of ventilation tubes have mixed tubes with wire attached to the slanted flange and ventilation tubes with wire attached to the straight flange. this poses no health hazard to the user or patient.
Acción
Consignees was sent a Summit Medical "Medical Device Recall" letter, dated May 9, 2014. The letter described the problem and the product involved in the recall. Requested consignees to examine their inventory and to quarantine the product. Consignees need to immediately examine their inventory quarantine any affected product. Also, they are to complete and return the "Recall Response Form." For questions they can contact Nicole Dove at (651) 789-3921 or ndove@summitmedicalusa.com.
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
Drill, surgical, ent (electric or pneumatic) including handpiece - Product Code ERL
Causa
Stryker instruments is voluntarily recalling the single use 2.5mm aggressive blade because the line on the affected part (p/n 5290-928-000, lot #13280cg2) was a straight line without a number scale or logo. the line required for this part number includes a number scale that goes from 1cm 7cm.
Acción
Stryker Instruments sent an Recall Notification dated March 18, 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer.
Customers were instructed if you have further distributed this product, please forward this letter and the attached Business Reply Form (BRF)to all affected locations. Please indicate each location on the BRF.
A FedEx shipping label will be emailed to each account upon receipt of the signed Business Reply Form. This label will allow the account to return the product to be destroyed.
A Business Reply Form will be included in each mailing. Return of this form will serve as confirmation that the account has received the notification and executed the recall. Follow up phone calls, emails, and faxes will be sent to non-responding accounts as necessary.
Product destruction will be handled at Stryker Instruments, Kalamazoo. Labeling will be defaced and the Aggressive Blades will be disposed of in the trash compactor.
For questions regarding this recall please contact Stryker Instruments:
Monday-Friday 8am-5pm (EST) 269-389-2921
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.
Notas adicionales en la data
Drill, surgical, ent (electric or pneumatic) including handpiece - Product Code ERL
Causa
Product did not reach expected sterility assurance level.
Acción
The firm, Aspach, sent an "URGENT: MEDICAL DEVICE LABELING CORRECTION" letter dated May 13, 2013 to its consignees/customers. The letter described the product, problem and actions to be taken. The consignees/ customers were instructed that Sterrad 100S system should not be used on the MIA 16 attachment (the information only applies to only Sterrad sterilization of this devices and not to any other attachments.), and complete and return the Return Receipt Requested Customer Reply form via fax to: 1-800-327-6661 or email: ProductSupportTeam@synthes.com. If you distribute any of the products to other services or facilities, please forward this information as appropriate.
Should you have any queries, please do not hesitated to contact Anspach Product Support at (800) 327-6887. Hours of Operation are 8:30am-5:30pm Eastern Standard Time or email: ProductSupportTeam@synthes.com.
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, laryngeal (taub) - Product Code EWL
Causa
Inhealth technologies (iht) is recalling the blom-singer adjustable tracheostoma valve ii (atsv ii) because the body component of the device is missing from the packaging. the atsv ii valve product cannot be used as intended without the product body.
Acción
A phone script and a customer notification letter are provided. The recall was initiated on 10/1/13 and customers will be notified that InHealth Technologies, a division of Helix Medical, LLC has initiated a recall of the following 3 lots of the Blom-Singer Adjustable Tracheostoma Valve (BE8025H and BE8025H-R3): 1057760, 1057919 and 1059222. The phone script provides the problem identified and the actions to be taken. Customers are instructed to complete the Customer response form and return by email to belinda.jackson@helixmedical.com, fax to (805) 566-5381 or by mail to InHealth Technologies, 1110 Mark Avenue, Carpinteria, CA 93013. Customers are also instructed to Contact UPS at 1-800-742-5877 and provide In Health Technologies UPS account no., 846718. UPS will come to your site, package the recalled product(s) and ship it to InHealth Technologies at InHealth Technologies expense. Customers are instructed to respond within 10 days.
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
Total & partial middle ear prostheses, ossicular - Product Code ETA
Causa
One lot of the product was assembled using the cam head version of the same prosthesis instead of the round head shaft.
Acción
An "URGENT PRODUCT RECALL" letter was faxed to customers following the initial telephone notification. The letter described the product issue and provided recommended actions. Questions were directed to customer service at 800-874-5797.
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
Tray, surgical, ent - Product Code MMO
Causa
The firm will recall and replace the identified instrument trays in the field, with trays that have improved labeling, including lids that contain the statement indicating 'prevacuum only".
Acción
Medtronic sent a Customer Commincation Recall Letter to all affected customers with the following information: Subject: URGENT PRODUCT Recall Immediate Attention Required
MEDTRONIC XOMED INSTRUMENT TRAYS
- model numbers provided on Attachment One
- all lots distributed prior to July 2013
Dear Purchasing Manager, Risk Manager and Central Supply Manager/Supervisor:
This letter is to inform you that Medtronic Surgical Technologies (ENT Division) is initiating a voluntary recall to remove certain instrument trays from the field and replace them with trays that have modified labeling. Medtronic Xomed Instrument Trays are intended for the storage and transportation of reusable surgical instruments. These trays are not intended and not designed to maintain sterility. We are aware, however, that some users may also choose to use the trays for holding instruments during steam sterilization. If the user chooses to sterilize instruments within these instrument trays, they must validate the sterilization process. These users should be aware of the following issue:
Issue Description:
During the validation of a new instrument, testing revealed that use of a GRAVITY steam cycle with one of the listed instrument trays did not produce the Sterility Assurance Level (SAL) of 10-6 recommended by industry standard (ANSI/AAMI ST77:2006). A subsequent investigation of all Medtronic Xomed instrument trays identified additional trays as having certain locations within the
tray that would not meet the recommended sterilization level of SAL10-6 during GRAVITY steam sterilization cycles. The trays identified through the testing are the subject trays involved in this field action. Instruments that are sterilized in the worst-case locations of the identified trays have a higher potential to be inadequately sterilized. An instrument that is inadequately sterilized can become the source of cross-contamination or cross-infection when used in multiple surgical procedures. At this time
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
Drill, surgical, ent (electric or pneumatic) including handpiece - Product Code ERL
Causa
The safety margin values detailed in the engineering design were entered incorrectly into the programming software. handpieces that have been programmed with the incorrect parameters could result in unintended activation. there is a potential for injury to the patient or user as a result of unintended forward or reverse activation. there is also the potential that the handpiece may not reach 100.
Acción
The firm, Stryker Instruments, sent emails beginning May 30, 2013 "URGENT MEDICAL DEVICE CORRECTION" letter dated July 1, 2013 to its customers. The letter identified the device, the reason for the recall, possible adverse events and actions to be taken. The customers were instructed to immediately review this letter, locate the units listed, complete and return the business reply form via FAX to 866-521-2762; or email Kara.spath@stryker.com; if you have further distributed this product, please forward this letter and the attached Business Reply Form to all affected locations. After receiving this form, Stryker will send you a pre-paid shipper to send your affected device(s)back to Stryker to be reprogrammed with the correct specifications. Send back all affected devices using the pre-paid shipper provided to you by Stryker. If you require a loaner, please contact the Stryker Service Department to arrange for a loaner at 888-308-1983.
For questions regarding this recall please Stryker Instruments: Monday-Friday 8am-5pm (EST) 269-389-4518 / 269-389-3808 kara.spath@stryker.com / jennifer.mars@stryker.com.
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
Drill, surgical, ent (electric or pneumatic) including handpiece - Product Code ERL
Causa
The safety margin values detailed in the engineering design were entered incorrectly into the programming software. handpieces that have been programmed with the incorrect parameters could result in unintended activation. there is a potential for injury to the patient or user as a result of unintended forward or reverse activation. there is also the potential that the handpiece may not reach 100.
Acción
The firm, Stryker Instruments, sent emails beginning May 30, 2013 "URGENT MEDICAL DEVICE CORRECTION" letter dated July 1, 2013 to its customers. The letter identified the device, the reason for the recall, possible adverse events and actions to be taken. The customers were instructed to immediately review this letter, locate the units listed, complete and return the business reply form via FAX to 866-521-2762; or email Kara.spath@stryker.com; if you have further distributed this product, please forward this letter and the attached Business Reply Form to all affected locations. After receiving this form, Stryker will send you a pre-paid shipper to send your affected device(s)back to Stryker to be reprogrammed with the correct specifications. Send back all affected devices using the pre-paid shipper provided to you by Stryker. If you require a loaner, please contact the Stryker Service Department to arrange for a loaner at 888-308-1983.
For questions regarding this recall please Stryker Instruments: Monday-Friday 8am-5pm (EST) 269-389-4518 / 269-389-3808 kara.spath@stryker.com / jennifer.mars@stryker.com.
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
Drill, surgical, ent (electric or pneumatic) including handpiece - Product Code ERL
Causa
The safety margin values detailed in the engineering design were entered incorrectly into the programming software. handpieces that have been programmed with the incorrect parameters could result in unintended activation. there is a potential for injury to the patient or user as a result of unintended forward or reverse activation. there is also the potential that the handpiece may not reach 100.
Acción
The firm, Stryker Instruments, sent emails beginning May 30, 2013 "URGENT MEDICAL DEVICE CORRECTION" letter dated July 1, 2013 to its customers. The letter identified the device, the reason for the recall, possible adverse events and actions to be taken. The customers were instructed to immediately review this letter, locate the units listed, complete and return the business reply form via FAX to 866-521-2762; or email Kara.spath@stryker.com; if you have further distributed this product, please forward this letter and the attached Business Reply Form to all affected locations. After receiving this form, Stryker will send you a pre-paid shipper to send your affected device(s)back to Stryker to be reprogrammed with the correct specifications. Send back all affected devices using the pre-paid shipper provided to you by Stryker. If you require a loaner, please contact the Stryker Service Department to arrange for a loaner at 888-308-1983.
For questions regarding this recall please Stryker Instruments: Monday-Friday 8am-5pm (EST) 269-389-4518 / 269-389-3808 kara.spath@stryker.com / jennifer.mars@stryker.com.
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
Lack of sterility assurance.
Acción
Cyrus ACMI notified their direct accounts of the recall by Priority Mail with delivery confirmation on May 24, 2013. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to inspect their inventory and immediately cease any further use of any affected product they may have, remove it from inventory, and quarantine it until they ship it back to the firm. For questions customers were instructed to contact their Olympus customer service representative at 1-800-848-9024 to obtain a Returned Goods Authorization so that they may return the product with no charge to them. Customers were asked to note on the enclosed questionnaire that they have received this information and fax it to 484-896-7128.
For questions regarding this recall call 508-804-2739.
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 Knives - Product Code JYO
Causa
Summit medical has initiated a recall of myringotomy lance blade (juvenile) because the box contains the wrong blade. the box contains myringotomy spear blade (juvenile).
Acción
Summit Medical sent a Medical Device Recall letter dated March 27, 2013, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer.
Customers were instructed to immediately examine your inventory, and quarantine the product subject to this recall.
Please complete and return the enclosed "Recall Response Form" as soon as possible. The fax number is (651) 789-3961.
For further questions please call (651) 789-3921.
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
In march 2013, medtronic issued a recall of the nim trivantage emg endotracheal tube due to cuff leakage in the intraoperative cuff deflation which then requires re-inflation or replacement of the deflated tube in order to ensure the continued ventilation of the patient.
Acción
The firm, Medtronic Xomed, Inc. sent an "URGENT Product Recall Notification" letter dated March 14, 2013, to its U.S. and International customers. The letter described the product, problem and actions to be taken. The customers were instructed to return any affected devices still in their possession per the following procedure: 1. Check inventories for the affected products listed on the enclosed checklist. 2. Fill-in the "quantity on-hand" column on the checklist. 3. Fax checklist to Medtronic ENT at 1-904-296-2386. 4. If you have any of the subject product, contact Medtronic ENT Customer Service at 1-800-874-5797 to arrange for returns and replacement or credit. 5.When returning products, clearly mark the outside of the container Returned Goods Authorization (RGA) number.
If you have any questions regarding the subject action or the content of the letter, contact Gabriela Anchondo at 904-279-7550.
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
Bronchoscope accessory - Product Code KTI
Causa
Labeling correction for all sizes of the inspira air balloon dilation system to include additional language and warnings as well as to clarify some instructional steps.
Acción
Urgent Medical Device Labeling correction letters will be sent to all consignees through a delivery system that can track delivery. After CDRH review and corrections, Acclarent began issuing customer notification on August 7, 2013
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
Bronchoscope accessory - Product Code KTI
Causa
Labeling correction for all sizes of the inspira air balloon dilation system to include additional language and warnings as well as to clarify some instructional steps.
Acción
Urgent Medical Device Labeling correction letters will be sent to all consignees through a delivery system that can track delivery. After CDRH review and corrections, Acclarent began issuing customer notification on August 7, 2013
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
Bronchoscope accessory - Product Code KTI
Causa
Labeling correction for all sizes of the inspira air balloon dilation system to include additional language and warnings as well as to clarify some instructional steps.
Acción
Urgent Medical Device Labeling correction letters will be sent to all consignees through a delivery system that can track delivery. After CDRH review and corrections, Acclarent began issuing customer notification on August 7, 2013
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
Bronchoscope accessory - Product Code KTI
Causa
Labeling correction for all sizes of the inspira air balloon dilation system to include additional language and warnings as well as to clarify some instructional steps.
Acción
Urgent Medical Device Labeling correction letters will be sent to all consignees through a delivery system that can track delivery. After CDRH review and corrections, Acclarent began issuing customer notification on August 7, 2013