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, patient rotation, powered - Product Code IKZ
Causa
Buckles used to secure patient to surface during proning therapy can come open if not properly engaged by user.
Acción
Firm sent a letter with the "Warning: Improper Insertion of the RotoProne Therapy System Buckle Can Lead To Unintentional Bed Exit" to all consignees on 2/23/2011. The letter identified the affected product and the reason for the recall. Customers were instructed to read the attached product warning regarding the proper method to attach the RotoProne buckles and to post it with the device to ensure continued proper use of the buckles. If customers had questions regarding the proper use of the buckles, they were to contact KCI Customer Technical Service at 1-800-275-4524.
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.
Accolade tmzf plus hip stems are being recalled due to grit blast media which was observed in the drive hole.
Acción
Stryker Orthopaedics sent an Urgent Product Recall letter dated March 1, 2011, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to fax back the attached Product Recall Acknowledgement Form within 5 days to 201-831-6069.
Customers were also instructed to:
Contact the hospitals in their territory that have the affected product to arrange return of the product.
Return the affected product via and Inter-Org Transfer to the attention of Regulatory Compliance, Stryker Orthopaedics, 325 Corporate Drive, Mahwah, New Jersey 07430.
Attach the fluorescent orange PRODUCT REMEDIATION sticker to their return, indicating the Product Remediation # RA 2009-459. Mark the outer box with the words "Product Recall."
For any questions call (201) 972-2100.
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
Patient electrode sensor kit - Product Code IKD
Causa
Vermed kits contain a product component (triad alcohol prep pads) recalled due to potential bacillus cereus contamination.
Acción
Vermed sent consignee a recall notification letter on February 8, 2011, followed by a phone call and email. The consignee was instructed to respond with a Recall Reply Form via fax and to notify any customers to whom the affected product was further distributed. All recalled alcohol prep pads were to be returned to Triad Group. Firm is replacing Triad alcohol pads in kits with pads from another supplier and has removed Triad from its approved vendor list.
For questions regarding this recall call 802-722-9976.
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
Joint, knee, external limb - Product Code ISY
Causa
The recall was initiated based on a finding by ossur that some units of the total knee 2100 produced from october 19th, 2010 until january 21st 2011, contained back links that may compromise knee function prematurely.
Acción
Ossur initiated a Safety Notice (Voluntary Product Recall) letter on February 11, 2011, via US Postal Service Registered Mail. The recall letter informed the affected customers of the reason for the recall and the product affected.
Ossur requested their distributor and providers take the following action:
(1) Please identify the users of each of the Total Knee 2100 model devices listed above;
(2) Also, please check your inventory and isolate any recalled devices you have on hand but have not fitted on users.
Customers were also informed that a representative from Ossur customer service will be contacting them to coordinate replacement of the affected devices.
The letters were followed by phone calls placed by a trained Ossur Customer Service Representative to each customer after US distributors provided Ossur with customer contact information.
For questions regarding this recall call 517-629-8890.
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.
Due to product age and parts availability the units are being withdrawn to reduce a potential health risk to patients when bed rails are not used.
Acción
Hill-Rom Manufacturing, Inc. sent an Urgent Medical Device Withdrawal letter dated December 15, 2010, to all affected consignees. The letter identified the product, the problem, and the action to be taken by the customer. The FLEXICAR MC3 AND FLEXICAIR 13000 were no longer available for rental as of November 15, 2010. Customers in Michigan were required to switch to another product by December 31, 2010. All other customers were required to switch to another product by March 4, 2011. Customers advised to continue the use of the product until arrangements could be made to replace the product. were notified by letter on/about 12/06/2010. The letter indicated the units will no longer be available for rental as of 11/15/2010. Patients in Michigan currently using the products will be required to switch to another product by 12/31/2010. All other patients using the products will be required to switch to another product by 03/04/2010. They were advised that a Hill-Rom representative will be contacted them to discuss details of the product withdrawal and possible alternative surfaces for their patients.
For questions regarding this recall call 800-445-3720.
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.
Due to product age and parts availability the units are being withdrawn to reduce a potential health risk to patients when bed rails are not used.
Acción
Hill-Rom Manufacturing, Inc. sent an Urgent Medical Device Withdrawal letter dated December 15, 2010, to all affected consignees. The letter identified the product, the problem, and the action to be taken by the customer. The FLEXICAR MC3 AND FLEXICAIR 13000 were no longer available for rental as of November 15, 2010. Customers in Michigan were required to switch to another product by December 31, 2010. All other customers were required to switch to another product by March 4, 2011. Customers advised to continue the use of the product until arrangements could be made to replace the product. were notified by letter on/about 12/06/2010. The letter indicated the units will no longer be available for rental as of 11/15/2010. Patients in Michigan currently using the products will be required to switch to another product by 12/31/2010. All other patients using the products will be required to switch to another product by 03/04/2010. They were advised that a Hill-Rom representative will be contacted them to discuss details of the product withdrawal and possible alternative surfaces for their patients.
For questions regarding this recall call 800-445-3720.
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
Vehicle, motorized 3-wheeled - Product Code INI
Causa
The main harness connector was manufactured without the required back shield sealing protection. as a result, there is the potential for water to seep through the nonconforming harness.
Acción
Three (3) pieces of information was distributed in the notification. They are: (1) Letter of Correction to the Provider (2) Letter of Correction for the Consumer (provider to issue to consumer) (3) Product Insert for Victory 9 Controller Interface Harness Replacement. The letter of Correction for Victory 9 with Power Sear (SC609PS), dated November 2010, identified the affected product and the reason for the correction. Customers were to record the serial number(s) and contact their provider's office to make an appointment to have the harness 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.
Risk of burns-- under certain conditions, devices containing a gold plated end block could produce energy above what is stated on the device setting.
Acción
Cutera sent Certified letters sent to all consignees on May 8, 2010. The letter identified the product, the problem, and the action the consignees should take. Consigness were instructed to immediately stop using the handpiece and complete the attached Recall Tracker Form. A second letter was sent to customers who received a replacement handpiecce but did not return the affected devices. All affected products were to be exchanged for new or reworked devices.
For questions contact customer service at (888) 428-8372, ext 5561.
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, muscle, powered - Product Code IPF
Causa
The charge current is leaking through two diodes, which are supposed to block the reverse current, when the device is warm during the main battery charge operation, it then causes the lithium battery to swell around two years of use and it causes the device to be inoperable.
Acción
Since June 11, 2008, RS Medical has taken the following actions when the device was sent back through a consumer complaint, or when the device was returned for routine maintenance, or through the rental service. The firm has upgraded the blocking diodes with higher temperature rated diodes, replaced the Lithium coin cell battery, and the software register bit has been changed to denote for subsequent automated testing that the diode upgrade/Lithium coin cell battery replacement has occurred.
The firm reported that the device must be returned for the rechargeable NiMH battery replacement around two years of use, and the battery should not be replaced by patients.
On 10/29/10, the firm began sending out URGENT NOTICE of VOLUNTARY RECALL letters to their customers. The firm will continue to send out the letters through 2011.
The letter states the recall product as RS-4i Sequential Stimulator, Affected Serial Numbers 4i300000 to 4i467119.
The customers are informed that "RS-4i Sequential Stimulators, only those within the affected serial number range indicated above, are susceptible to early expiration of the lithium coin cell battery that provides back-up power to the device memory when the stimulator is powered OFF. Customer experience indicates that the 3V lithium coin cell battery can be depleted as early as one third of its rated life. The RS-4i Stimulator will perform as intended until the lithium coin cell battery is fully depleted. When this happens, the Stimulator will turn OFF and fail to turn ON, even if it has been charged by battery charger connection to a standard electrical wall outlet".
Customers are advised to make a schedule for a free Return and Repair of a RS-4i Sequential Stimulator and should call the Toll Free Service Line at 877-363-5753 (English) or 877-363-5754 (Spanish) from 6AM to 5PM (Pacific Time) Monday-Friday.
If the customers have any other questions or to review additional information before scheduling a device
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
Powered Wheeled Stretcher - Product Code INK
Causa
The retractable cord stretchers were fitted with power cords, manufactured by electri-cord, whose prongs have the potential to fracture inside the molded section of the plug, causing melting and charring.
Acción
The firm has sent Urgent - Medical Device Recall letters, dated March 19, 2010, to all direct accounts notifying them of the recall. The letter identified the affected product and described the reason for recall. Customers were asked to locate the stretchers identified in the letter and visually inspect each cord. If the plug shows signs of excessive wear, etc. the stretcher is to be taken out of service immediately and the plug removed. Customers are to call the number provided in order to be placed on the priority replacement list. If the cord does not show signs of damage then the stretcher can remain in service until a replacement cord is available. The enclosed post card should be completed and returned to the firm. A copy of the notice should be forwarded to any users that stretchers have been sold or loaned to. The firm should be provided with the serial numbers of any stretchers that have been disposed of. Questions should be directed towards Stryker at 800-STRYKER.
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
Powered Wheeled Stretcher - Product Code INK
Causa
The retractable cord stretchers were fitted with power cords, manufactured by electri-cord, whose prongs have the potential to fracture inside the molded section of the plug, causing melting and charring.
Acción
The firm has sent Urgent - Medical Device Recall letters, dated March 19, 2010, to all direct accounts notifying them of the recall. The letter identified the affected product and described the reason for recall. Customers were asked to locate the stretchers identified in the letter and visually inspect each cord. If the plug shows signs of excessive wear, etc. the stretcher is to be taken out of service immediately and the plug removed. Customers are to call the number provided in order to be placed on the priority replacement list. If the cord does not show signs of damage then the stretcher can remain in service until a replacement cord is available. The enclosed post card should be completed and returned to the firm. A copy of the notice should be forwarded to any users that stretchers have been sold or loaned to. The firm should be provided with the serial numbers of any stretchers that have been disposed of. Questions should be directed towards Stryker at 800-STRYKER.
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
Powered Wheeled Stretcher - Product Code INK
Causa
The retractable cord stretchers were fitted with power cords, manufactured by electri-cord, whose prongs have the potential to fracture inside the molded section of the plug, causing melting and charring.
Acción
The firm has sent Urgent - Medical Device Recall letters, dated March 19, 2010, to all direct accounts notifying them of the recall. The letter identified the affected product and described the reason for recall. Customers were asked to locate the stretchers identified in the letter and visually inspect each cord. If the plug shows signs of excessive wear, etc. the stretcher is to be taken out of service immediately and the plug removed. Customers are to call the number provided in order to be placed on the priority replacement list. If the cord does not show signs of damage then the stretcher can remain in service until a replacement cord is available. The enclosed post card should be completed and returned to the firm. A copy of the notice should be forwarded to any users that stretchers have been sold or loaned to. The firm should be provided with the serial numbers of any stretchers that have been disposed of. Questions should be directed towards Stryker at 800-STRYKER.
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
Powered Wheeled Stretcher - Product Code INK
Causa
The retractable cord stretchers were fitted with power cords, manufactured by electri-cord, whose prongs have the potential to fracture inside the molded section of the plug, causing melting and charring.
Acción
The firm has sent Urgent - Medical Device Recall letters, dated March 19, 2010, to all direct accounts notifying them of the recall. The letter identified the affected product and described the reason for recall. Customers were asked to locate the stretchers identified in the letter and visually inspect each cord. If the plug shows signs of excessive wear, etc. the stretcher is to be taken out of service immediately and the plug removed. Customers are to call the number provided in order to be placed on the priority replacement list. If the cord does not show signs of damage then the stretcher can remain in service until a replacement cord is available. The enclosed post card should be completed and returned to the firm. A copy of the notice should be forwarded to any users that stretchers have been sold or loaned to. The firm should be provided with the serial numbers of any stretchers that have been disposed of. Questions should be directed towards Stryker at 800-STRYKER.
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
Powered Wheeled Stretcher - Product Code INK
Causa
The retractable cord stretchers were fitted with power cords, manufactured by electri-cord, whose prongs have the potential to fracture inside the molded section of the plug, causing melting and charring.
Acción
The firm has sent Urgent - Medical Device Recall letters, dated March 19, 2010, to all direct accounts notifying them of the recall. The letter identified the affected product and described the reason for recall. Customers were asked to locate the stretchers identified in the letter and visually inspect each cord. If the plug shows signs of excessive wear, etc. the stretcher is to be taken out of service immediately and the plug removed. Customers are to call the number provided in order to be placed on the priority replacement list. If the cord does not show signs of damage then the stretcher can remain in service until a replacement cord is available. The enclosed post card should be completed and returned to the firm. A copy of the notice should be forwarded to any users that stretchers have been sold or loaned to. The firm should be provided with the serial numbers of any stretchers that have been disposed of. Questions should be directed towards Stryker at 800-STRYKER.
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
Essential medical supply, inc. is recalling w1801b and w1801r endurance hd walkers due to recent reports and tests that show the front caster may detach from the frame. the potential failures include a collapse of the plastic fork or shearing of the stud attaching the caster to the frame.
Acción
All Consignees were mailed an Urgent: Product Recall W1801B and W1801R Endurance HD Walkers notification on December 30, 2009. All notifications were sent first class mail in a 9" X 6" envelope. Response cards were included. The letter identified the affected product and the reason for recall. Customers were asked to examine their inventory for affected product and to discontinue further use or distribution of the product. If the product was further distributed, customers should contact their customers, advise them of the recall and have them return the units to them. Customers should follow the instructions provided for return and replacement of units.
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
Stair Climbing Wheelchair - Product Code IMK
Causa
A thermal breaker in the battery pack has the potential to open due to overheating and disable one third of the cells in the affected battery pack.
Acción
The company sent Medical Device Field Correction letters to all customers on February 22, 2010 by certified mail.
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, Powered - Product Code ITI
Causa
Improper set-up of the wire harness can allow wires to be pulled from their intended position and become caught under the motor mounting bracket located under the powered wheelchair. this can cause the wire connector and/or the wire itself to be pulled or pinched which can lead to a short or open circuit.
Acción
The recalling firm issued recall notifications with response cards to their dealers. Included with the notification was fasteners and an example letter for customer notification of the problem. Dealers were instructed to contact the end users to make arrangements with the customer/end user to verify that the devices were properly set up. If the dealers' inspection revealed that additional fasteners were required they dealer would install them. The recalling firm also issued a recall letter to consumers. The consumer recall letter included instructions that if the correction was completed by anyone other than the wheelchair provider, then the consumer should schedule an appointment with the wheelchair provider to ensure the correction was completed properly.
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, Powered - Product Code ITI
Causa
Improper set-up of the wire harness can allow wires to be pulled from their intended position and become caught under the motor mounting bracket located under the powered wheelchair. this can cause the wire connector and/or the wire itself to be pulled or pinched which can lead to a short or open circuit.
Acción
The recalling firm issued recall notifications with response cards to their dealers. Included with the notification was fasteners and an example letter for customer notification of the problem. Dealers were instructed to contact the end users to make arrangements with the customer/end user to verify that the devices were properly set up. If the dealers' inspection revealed that additional fasteners were required they dealer would install them. The recalling firm also issued a recall letter to consumers. The consumer recall letter included instructions that if the correction was completed by anyone other than the wheelchair provider, then the consumer should schedule an appointment with the wheelchair provider to ensure the correction was completed properly.
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.
The plastic enclosures for the x3 display and x3 pro pressure mapping system has a ul94 hb flammability rating while the medical equipment specification ul 60601-1 requires v-2 rated plastic for electronic enclosures.
Acción
On July 6, 2009, Xsensor sent an "URGENT: MEDICAL DEVICE RECALL" notifications to their consignees/customers.
The consignees/customers were informed that the incorrect material of the plastic enclosures was used. The incorrect plastic had a UL94 HB flammability rating while the medical equipment specification UL 60601-1 required V-2 rated plastic for electronic enclosures.
The firm provided prepaid shipping box to consignees/customers with instructions for returning the components. The components were refurbished and returned to consignees for free of charge.
For further information please contact XSENSORs Customer Support at 1-866-927-5222.
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
Pack, Hot or cold, Water Circulating - Product Code ILO
Causa
Product is labeled as "sterile". it was observed that incomplete seals were created in the packaging materials during production. when the seal is compromised, the sterility of the product inside the package cannot be assured.
Acción
On November 14, 2009, Cincinnati Sub-zero Products, Inc. (CSZ) sent a recall notification letter and response letter to customers. A second notice dated December 10, 2009 was also issued to customers. Customers were instructed in the notifications to assume the recalled product is not sterile and do not use. CSZ requested all affected product be returned to their firm for replacement. Customers are to complete and return the response letter acknowledging receipt of the recall letter. Direct questions to CSZ by calling Customer Service at 1-800- 989-7373. Customers may also call 1-800-989-7373, extension 3234 or 1-51 3-71 9-3234 for recall instructions. Representatives will be available to take your call from 8:30 a.m. until 4:30 p.m. eastern standard time, Monday through Friday.
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.
Power cords may crack and fail inside plug with potential for fire hazard.
Acción
Kinetics Concepts, Inc. (KCI) issued an "Urgent Medical Device Correction" letter dated November 4, 2009. Consignees were informed of the affected product and instructed to take necessary action to avoid any further issues associated with the product.
For further information, contact KCI's technical support team at 1-800-275-4524 option #3.
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.
Power cords may crack and fail inside plug with potential for fire hazard.
Acción
Kinetics Concepts, Inc. (KCI) issued an "Urgent Medical Device Correction" letter dated November 4, 2009. Consignees were informed of the affected product and instructed to take necessary action to avoid any further issues associated with the product.
For further information, contact KCI's technical support team at 1-800-275-4524 option #3.
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.