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
Transfer Aid - Product Code IKX
Causa
Safety chair used in shower/bath may not meet specifications for weight load.
Acción
The subsidiary distributor, Maddak, Inc. notified customers by A "Voluntary Product Recall Notice", phone and e-mail on 07/09/2009. The own label distributor instructed customers to return their inventory of affected products received between May 1, 2009 and July 7, 2009. Distributors were instructed to immediately quarantine then return all affected inventory to Maddak and notify their accounts. Distributors were requested to instruct dealers to display a "storefront" notice and provide consumers with a customer response form. Distributors were also requested to forward a request to dealers to post a website notice if they have one. Recovered products will be 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.
Notas adicionales en la data
Transfer Aid - Product Code IKX
Causa
Safety chair used in shower/bath may not meet specifications for weight load.
Acción
The subsidiary distributor, Maddak, Inc. notified customers by A "Voluntary Product Recall Notice", phone and e-mail on 07/09/2009. The own label distributor instructed customers to return their inventory of affected products received between May 1, 2009 and July 7, 2009. Distributors were instructed to immediately quarantine then return all affected inventory to Maddak and notify their accounts. Distributors were requested to instruct dealers to display a "storefront" notice and provide consumers with a customer response form. Distributors were also requested to forward a request to dealers to post a website notice if they have one. Recovered products will be 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.
Notas adicionales en la data
Transfer Aid - Product Code IKX
Causa
Safety chair used in shower/bath may not meet specifications for weight load.
Acción
The subsidiary distributor, Maddak, Inc. notified customers by A "Voluntary Product Recall Notice", phone and e-mail on 07/09/2009. The own label distributor instructed customers to return their inventory of affected products received between May 1, 2009 and July 7, 2009. Distributors were instructed to immediately quarantine then return all affected inventory to Maddak and notify their accounts. Distributors were requested to instruct dealers to display a "storefront" notice and provide consumers with a customer response form. Distributors were also requested to forward a request to dealers to post a website notice if they have one. Recovered products will be 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.
Notas adicionales en la data
Transfer Aid - Product Code IKX
Causa
Safety chair used in shower/bath may not meet specifications for weight load.
Acción
The subsidiary distributor, Maddak, Inc. notified customers by A "Voluntary Product Recall Notice", phone and e-mail on 07/09/2009. The own label distributor instructed customers to return their inventory of affected products received between May 1, 2009 and July 7, 2009. Distributors were instructed to immediately quarantine then return all affected inventory to Maddak and notify their accounts. Distributors were requested to instruct dealers to display a "storefront" notice and provide consumers with a customer response form. Distributors were also requested to forward a request to dealers to post a website notice if they have one. Recovered products will be 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.
Notas adicionales en la data
Water Circulating Hot or Cold Pack - Product Code ILO
Causa
Power supplies short-circuited at the electrical outlet upon initial use of the power supply, causing the circuit breaker for the electrical outlet to trip.
Acción
An Urgent: Medical Device Recall Notification was sent to customers on June 18, 2009.
FOR USERS: Customers are advised to immediately open all unused Kodiak cold therapy units and inspect the lot code of the Power Supply included with the Kodiak unit. If the lot code is 3508, 3908, 4308, or 4808, then remove the power supply, cut the cord using scissors and discard. Call Breg Customer Service for a replacement: 1-800-321-0607. Complete and return the response form ASAP.
FOR DISTRIBUTORS: Send Breg your distribution information, including contact and quantities. Breg will notify your customers of the recall directly.
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 Valve - Product Code ISP
Causa
The plastic caps have come off or become loose when the user stepped into their prosthesis.
Acción
Customers were sent a Safety Notice Voluntary Product Recall, dated June 23, 2009, that advised them to return any unused valves to Ossur for a free replacement. Those using valves in combination with a cushion liner and suspension sleeve should replace immediately if problems are experienced, otherwise replace at next routine service. Customers using valve in combination with an Iceross Seal-In liner should replace ASAP and return used valves to Ossur for free replacement. Customers with questions can call Darlyne Roa 1-800-233-6263 ext 1023743.
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.
Healing abutment was not made within required manufacturing specification. the product did not have the relief behind the thread, which does not allow proper seating.
Acción
Each of the US customers was contacted by phone. Following the phone contacts, Biomet 3i performed a follow- up of each call with a faxed letter. Each customer was instructed to check their respective inventory for the affected product and corresponding lot number. They were then requested to fax back a response form to Biomet 3i Regulatory Services to provide feedback concerning their inventory. They were also instructed to return the affected product to Biomet 3i. Contact Biomet 3i, LLC at 1.561.776.6706, if there are any questions.
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
Bed, air fluidized - Product Code INX
Causa
Incorrectly repaired power cord wires can potentially overheat resulting in smoldering sound foam in the base of the therapy bed.
Acción
Hill-Rom issued an "Urgent Field Safety Notice" letter dated February 2, 2009 addressed to Facility Risk Managers and Facility Administrators. The notice detailed the issue and instructed users on actions to be taken.
For further information, please contact Hill-Rom Customer Service at 1-800-638-2546.
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
Bed, air fluidized - Product Code INX
Causa
Incorrectly repaired power cord wires can potentially overheat resulting in smoldering sound foam in the base of the therapy bed.
Acción
Hill-Rom issued an "Urgent Field Safety Notice" letter dated February 2, 2009 addressed to Facility Risk Managers and Facility Administrators. The notice detailed the issue and instructed users on actions to be taken.
For further information, please contact Hill-Rom Customer Service at 1-800-638-2546.
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
Mechanical wheelchair - Product Code IOR
Causa
The handle has been breaking at a calculated weight of 65 kg which may have serious consequences (broken bones) depending on the circumstances of the break (e.G., user on ramps, hills, etc.).
Acción
The firm contacted their customers by telephone and then sent a recall notification letter to each customer on 6/15/2009. Questions are directed to email: Recalls@Invacare.com or phone: 800-333-6900.
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
Exerciser, powered - Product Code BXB
Causa
Changes to the stored "sensitivity" values may occur and leads to higher limits in the force and trajectory deviation.
Acción
Hocoma issued a letter dated May 27, 2009 to Lokomat users informing them of the affected device. Instructions were provided to avoid further problems with the product and users were asked to complete and return the provided Declaration to Field Safety Notice.
For further information, contact Hocoma at info@hocoma.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
Mechanical Walker - Product Code ITJ
Causa
The caster may separate from the frame completely causing injury to the user.
Acción
Essential Medical Supply Inc issued a Notice of Quarantine Letter to all customers on 04/30/09, identifying affected products as W1700B & W1700R Essential Rollators, Serial #'s KLD-E07090001 through KLD-E08020570, received after 11/05/2007. Firm issued a Device Recall Letter to all direct customers on 05/08/09 instructing them to do the following: (1) segregate and quarantine any affected product; (2) identify and notify any customers that may received the affected products, instructing them to return the product to their dealer; and (3) either return the affected products to Essential Medical Supply or destroy the products and send proof of destruction.
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
Cabinet, moist steam - Product Code IMB
Causa
A correction or removal, conducted to reduce a risk to health posed by a device, was not reported in writing to fda.
sybaritic, inc. conducted a recall on dermalife 2g equipment (spajet, spa oceana, spa feng shui) because of ir fan failure which resulted in the overheating and failure of the ir emitter and surrounding assembly.
Acción
Sybaritic, Inc. issued a "Safety Alert" dated April 15, 2008 informing "All Owners/Users of DermaLife 2G Equipment" of the affected device. The letter advised consignees on device use until the mandatory Filed Correction Kit is delivered.
For further questions, contact Sybaritic, Inc. at 1-800-445-8418.
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
Cabinet, moist steam - Product Code IMB
Causa
A correction or removal, conducted to reduce a risk to health posed by a device, was not reported in writing to fda.
sybaritic, inc. conducted a recall on dermalife 2g equipment (spajet, spa oceana, spa feng shui) because of ir fan failure which resulted in the overheating and failure of the ir emitter and surrounding assembly.
Acción
Sybaritic, Inc. issued a "Safety Alert" dated April 15, 2008 informing "All Owners/Users of DermaLife 2G Equipment" of the affected device. The letter advised consignees on device use until the mandatory Filed Correction Kit is delivered.
For further questions, contact Sybaritic, Inc. at 1-800-445-8418.
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
Cabinet, moist steam - Product Code IMB
Causa
A correction or removal, conducted to reduce a risk to health posed by a device, was not reported in writing to fda.
sybaritic, inc. conducted a recall on dermalife 2g equipment (spajet, spa oceana, spa feng shui) because of ir fan failure which resulted in the overheating and failure of the ir emitter and surrounding assembly.
Acción
Sybaritic, Inc. issued a "Safety Alert" dated April 15, 2008 informing "All Owners/Users of DermaLife 2G Equipment" of the affected device. The letter advised consignees on device use until the mandatory Filed Correction Kit is delivered.
For further questions, contact Sybaritic, Inc. at 1-800-445-8418.
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
Cabinet, moist steam - Product Code IMB
Causa
A correction or removal, conducted to reduce a risk to health posed by a device, was not reported in writing to fda.
sybaritic, inc. conducted a recall on dermalife 2g equipment (spajet, spa oceana, spa feng shui) because of ir fan failure which resulted in the overheating and failure of the ir emitter and surrounding assembly.
Acción
Sybaritic, Inc. issued a "Safety Alert" dated April 15, 2008 informing "All Owners/Users of DermaLife 2G Equipment" of the affected device. The letter advised consignees on device use until the mandatory Filed Correction Kit is delivered.
For further questions, contact Sybaritic, Inc. at 1-800-445-8418.
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
air therapy mattress - Product Code IOQ
Causa
The devices may emit smoke from the blower box assembly.
Acción
Urgent Field Safety Notice letter dated May 11, 2009. Hill-Rom service centers were notified by letter on 05/13/2009. Action to be taken are as follows: Rental Customers; In the next 60 days, Hill Rom will be removing the Flexicair¿ II and Flexicair¿ MC3 low Airloss Therapy Units from service to correct the devices. During that time, Hill-Rom may provide an equivalent substitute therapy to accommodate the patients who continue to need a pressure reducing therapy device. If t his malfunction occurs before a substitution or a corrected device is provided, unplug the device, remove the patient from the surface and notify Hill-Rom immediately. Facility-Owned Customers: In the next 60 days, for all facility owned Flexicair II and Flexicair¿ MC3 Low Airloss Therapy Units, a Hill-Rom service technician will either replace the affected components in the blower assembly or deliver an equivalent substitute unit from Hill-Rom's rental fleet. If this malfunction occurs before the device is corrected or a substitute provided, do as follows: unplug the device, remove the patient from the surface, and immediately notify Hill-Rom Technical Support using the attached listing their geographical region.
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
air therapy mattress - Product Code IOQ
Causa
The devices may emit smoke from the blower box assembly.
Acción
Urgent Field Safety Notice letter dated May 11, 2009. Hill-Rom service centers were notified by letter on 05/13/2009. Action to be taken are as follows: Rental Customers; In the next 60 days, Hill Rom will be removing the Flexicair¿ II and Flexicair¿ MC3 low Airloss Therapy Units from service to correct the devices. During that time, Hill-Rom may provide an equivalent substitute therapy to accommodate the patients who continue to need a pressure reducing therapy device. If t his malfunction occurs before a substitution or a corrected device is provided, unplug the device, remove the patient from the surface and notify Hill-Rom immediately. Facility-Owned Customers: In the next 60 days, for all facility owned Flexicair II and Flexicair¿ MC3 Low Airloss Therapy Units, a Hill-Rom service technician will either replace the affected components in the blower assembly or deliver an equivalent substitute unit from Hill-Rom's rental fleet. If this malfunction occurs before the device is corrected or a substitute provided, do as follows: unplug the device, remove the patient from the surface, and immediately notify Hill-Rom Technical Support using the attached listing their geographical region.
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
Cabinet, moist steam - Product Code IMB
Causa
Sybaritic conducted a recall on the hydration station 806 because of the potential for hot water to spurt through steam ports into unit and cause burns. also, potential for customers to inadvertently place their legs over the side wall of the unit directly onto the steam ports and cause burns.
there were 18 injuries and 8 malfunctions reported.
Acción
Sybaritic, Inc. issued a letter dated May 15, 2007 addressed to "Hydration Station Customer". The letter informed the customer of the new 2007 Hydration Station Upgrade Improvement Kits including instructions and advised the customer to coordinate the installation of the components with their Technical Service Department.
Further questions can be addressed to Sybaritic, Inc. Technical Administration at 1-800-445-8418 extension 373.
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
Rolling Walker - Product Code ITJ
Causa
The fork component on the wheel of the rollator can break due to the use of incorrect manufacturing material and/or molding processes.
Acción
The recall was initiated by phone on or about 6/20/06, to determine how many Rollators the customer had in stock because they had received reports of Rollators coming out of the box with cracked forks. During the phone call, the customer was told that the recalling firm was bringing back their remaining inventory for inspection and that customer service would be calling them back to arrange for return. The recalling firm issued a '2nd Recall Notice' dated 10/10/06 via UPS between 10/11-13/06 explaining the reason for recall, requesting their customers to conduct a subrecall down to the consumer level and instructing that all of the Rollators be destroyed.
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
Rolling Walker - Product Code ITJ
Causa
The fork component on the wheel of the rollator can break due to the use of incorrect manufacturing material and/or molding processes.
Acción
The recall was initiated by phone on or about 6/20/06, to determine how many Rollators the customer had in stock because they had received reports of Rollators coming out of the box with cracked forks. During the phone call, the customer was told that the recalling firm was bringing back their remaining inventory for inspection and that customer service would be calling them back to arrange for return. The recalling firm issued a '2nd Recall Notice' dated 10/10/06 via UPS between 10/11-13/06 explaining the reason for recall, requesting their customers to conduct a subrecall down to the consumer level and instructing that all of the Rollators be destroyed.
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
manual wheelchair - Product Code IOR
Causa
If the user has chosen to install optional anti-tippers on the chair, the anti-tipper as designed may not be able to bear the stress of repeated or quick loads placed on it, causing the bolt to bend or break.
Acción
The recalling firm notified all consignees by recall letter sent on or about 7/20/06 along with replacement anti-tippers for each device on hand.
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
walker wheel kits - Product Code ITJ
Causa
Walker wheel hubs may fracture, causing walker to collapse to one side.
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
walker, mechanical - Product Code ITJ
Causa
Walker wheel hubs may fracture, causing walker to collapse to one side.
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
wheelchair seat - Product Code ITI
Causa
Some of the wheelchairs were distributed with seats that did not have a seat positioning strap.
Acción
The recalling firm sent a recall letter, dated 06/06 to consignees.