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
Sling, arm - Product Code ILI
Causa
Owens & minor is the initial importer and private label distributor of medi choice arm slings (product). the product is manufactured in china by tops medical articles nantong inc.
owens & minor first learned of the product issue that prompted the product removal action via customer complaints received in september 2016. two customer complaints received on september 1"1, 2016 reported surface contamination on the arm slings. two additional complaints reported on september 19, 2016 and october 7, 2016 reported the same issue.
upon receipt of the complaints on september 1, 2016, owens & minor immediately initiated a capa investigation for root cause analysis and determination of corrective/preventive actions. a quality inspection of inventory confirmed that the surface contamination was confined to lots manufactured in may, june, and july of 2016. the surface contamination for these lots was found to be frequent. subsequent august product lots were inspected and no surface contamination was found. limited inventory from lots prior to may 2016 were available and inspected as well. no surface contamination was found on these prior lots.
owens & minor has quarantined the affected product lots. the product is on hold at all owens & minor distribution centers (dc). samples of contaminated product have been sent to the manufacturer for evaluation and to a certified testing lab for identification of contaminate. these results are pending at this time.
based on the frequency of the product defect as well as evaluation of potential adverse health event risk, owens & minor initiated a voluntary recall for the above stated affected product lots.
Acción
The firm, Owens&Minor;, sent an "URGENT MEDICAL DEVICE RECALL" letter dated 11/9/2016 to its consignees/customers including a Recall Response Form. The letter describe the product, problem and actions to be taken. The customers were instructed to examine your inventory and identify all affected product; immediately stop using all affected product; quarantine all affected product per your facility's Standard Operating Procedures; if you have further distributed this product, identify patients/customers who received product and notify them at once; and complete and return Recall Response Form via email: www.owens-minor.com, fax to 804-723-7100, or mail to the O&M; Distribution Center (DC) Attn: Recall Officer (even if you do not have any affected product). Note: upon receipt of the Recall Response Form, the DC will contact you with the appropriate RGA and instructions for product return.
If you have any questions concerning credit and/or replacement of affected product or this recall, please call 804-723-7000 or contact your O&M; Sales Representative or Customer Service Representative at the local O&M; Distribution Center.
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
Pad, heating, powered - Product Code IRT
Causa
Products manufactured with the spt cord have a known failure mode of sparking,causing smoke, fire and burns.
Acción
All consumers for which Battle Creek has contact information and that purchased a recalled pad will be contacted via first class mail. Consumers will be asked to contact us by phone after verifying that the model number and lot code is part of the recall. Battle Creek plans to add information about the recall on its web site including a pdf of the consumer letter. All customer consignees (non-consumer) will be informed of the recall. Email will be the most effective method , and mail and telephone calls will be used as needed.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notas adicionales en la data
Component, external, limb, ankle/foot - Product Code ISH
Causa
A software issue can make the foot move into dorsiflexion, unnoticed by the user, who could fall. when sitting, the prosthetic foot can go into the relief function to move the footplate towards the ground. when operating machines with foot pedals (e.G. a car) the foot could get stuck under the foot pedal and block it or, with the foot on the pedal, it could cause unintended vehicle acceleration.
Acción
OttoBock sent an Urgent Medical Device Correction letter dated October 23, 2015, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer.
The US Agent will notify US customers via letter on October 23, 2015, of the correction on behalf of the Manufacturer. Customers will be requested to contact all users and advise them of the hazards when operating machines or vehicles with foot pedals. They may forward a copy of the insert if needed. Customers will also be requested to contact all users with TF-fittings, where the settings were done via iOS Galileo app., inform the user about this issue, and assure that settings in the device are as expected.The customer will be requested to complete a reply form and return to the US Agent. For further questions call (800) 328-4058.
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, mechanical - Product Code IOR
Causa
Silver star brands is recalling the transport chair and rollator in one because they have received several reports of the wheel assembly failing resulting in damaged wheels.
Acción
Consignees were sent on 10/10/2014 an Easy Comforts "Urgent: Rollator Recall" letter dated October 10, 2014. The letter described the problem and the product involved in the recall. Advised consignees to stop using the product immediately. The consignees can contact the Product specialist at Easy Comforts at 1-888-327-2390 Monday though Friday from 7:30 am to 3:30 pm central 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
Chair, with casters - Product Code INM
Causa
A supplier manufacturing assembly defect with the right hand recline mechanism. use of this product may result in the loss of functionality of the three (3) position lock bar when in a reclined position.
Acción
Winco sent a Recliner Field Correction Notification letter dated September 11, 2013 to all affected consignees. The letter identified the product, the problem and action to be taken by the consignees. The consignees were instructed to complete and return the enclosed field correction response form back to Winco so they can send replacement mechanism(s) along with instructions on how to exchange the mechanism(s). Customers with questions were instructed to contact Customer Care at 800-237-3377 or email QA-RA@wincomfg.com.
For questions regarding this recall call 352-854-2929, ext 130.
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
Component, External, Limb, Ankle/Foot - Product Code ISH
Causa
After one year devices assembled with a new type of o-rings could exhibit enough wear to allow a gradual oil leak which would increase play in the ankle sub-assembly of the foot.
Acción
Telephone communication followed by notification letter mailed to end users (patients) and prosthetics workshops. A pre-paid package to return faulty components to Ossur included with mailed letters. New replacement feet will be shipped to customers.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notas adicionales en la data
System, Communication, Powered - Product Code ILQ
Causa
Pendant personal help button neck cord may not break away and if not will present a potential choking risk.
Acción
Philips Lifeline initiated Safety Notification letters on 9/21/09 to users and advised of the potential choking risk of the Pendant Personal Help Button The firm recommends that users consult their health care providers to determine which style of emergency button, including those that are worn on the wrist, is most beneficial for them. A postage-paid reply envelope had been provided. Questions should be addressed to Philips at 1-877-221-8756 (Monday Friday, 8 a.m. 8 p.m. EST).
Firm issued Press on 9/11/09. FDA Press issued 9/22/09
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 and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel data.
Notas adicionales en la data
Causa
Ossur is recalling the symbionic leg because it is not recognizing the low battery warning signal from the symbionic leg before it powers down.
Acción
Ossur Americas contacted all affected customers via phone on October 15, 2012 informing them that a software update for this product is required, along with the recommended instructions to return the product. A loaner prosthetic will be provided to the patient while the software update is being implemented.
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
Chair, with casters - Product Code INM
Causa
A supplier manufacturing assembly defect with the right hand recline mechanism. use of this product may result in the loss of functionality of the three (3) position lock bar when in a reclined position.
Acción
Winco sent a Recliner Field Correction Notification letter dated September 11, 2013 to all affected consignees. The letter identified the product, the problem and action to be taken by the consignees. The consignees were instructed to complete and return the enclosed field correction response form back to Winco so they can send replacement mechanism(s) along with instructions on how to exchange the mechanism(s). Customers with questions were instructed to contact Customer Care at 800-237-3377 or email QA-RA@wincomfg.com.
For questions regarding this recall call 352-854-2929, ext 130.
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
The lock pin can become stuck in the "in" position during the manual rotation, resulting in the inability to prone a patient.
Acción
ArjoHuntleigh Inc. sent a Technical Bulletin package to all affected service centers and an Urgent Field Safety Notice package to all affected customers. For rental units, a training plan was established for employees. For sold units, the notice contain a revised user manual and label explaining what to do if the lock pin becomes stuck in the "in" position. Customers that purchased the affected product were required to complete and return a Customer Response form to ArjoHuntleigh to confirm receipt and understanding of the field safety notice, and that the required actions were completed. For questions call 630-785-4885.
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
The unit displays an error code of hose kinking when no hose kink is present; the unit fails to monitor the temperature of the water in the blanket as intended and controlling it through the automatic temperature control. this failure could result in temperature injuries to the treatment site; and there have been two reports of electric shock.
Acción
DeRoyal sent a "URGENT VOLUNTARY RECALL DEROYAL HOT/COLD THERAPY UNIT" letter dated September 17, 2013. The letter identified the product, problem, and actions to be taken by the customers.
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
The unit displays an error code of hose kinking when no hose kink is present; the unit fails to monitor the temperature of the water in the blanket as intended and controlling it through the automatic temperature control. this failure could result in temperature injuries to the treatment site; and there have been two reports of electric shock.
Acción
DeRoyal sent a "URGENT VOLUNTARY RECALL DEROYAL HOT/COLD THERAPY UNIT" letter dated September 17, 2013. The letter identified the product, problem, and actions to be taken by the customers.
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
The unit displays an error code of hose kinking when no hose kink is present; the unit fails to monitor the temperature of the water in the blanket as intended and controlling it through the automatic temperature control. this failure could result in temperature injuries to the treatment site; and there have been two reports of electric shock.
Acción
DeRoyal sent a "URGENT VOLUNTARY RECALL DEROYAL HOT/COLD THERAPY UNIT" letter dated September 17, 2013. The letter identified the product, problem, and actions to be taken by the customers.
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 Clamp adapters - Product Code ISH
Causa
Device fracturing: recent design and process changes leave the device susceptible to fracturing, which could cause the prosthesis to fail.
Acción
On October 6, 2006, SPS faxed a recall notification to the 187 customers who had purchased one or more BL120M Tube Clamp Adapters from SPS between August 29 and September 20, 2006. On October 9, SPS contacted those customers that had purchased five or more Adapters via telephone to confirm they had received the faxed recall notification. On October 10, SPS mailed another copy of the recall notification, via certified mail, return receipt requested to all of its customers that had purchased one or more BL120M Tube Clamp Adapters. The customers were told to send the BL120M Adapter back to SPS following replacement.
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
The unit displays an error code of hose kinking when no hose kink is present; the unit fails to monitor the temperature of the water in the blanket as intended and controlling it through the automatic temperature control. this failure could result in temperature injuries to the treatment site; and there have been two reports of electric shock.
Acción
DeRoyal sent a "URGENT VOLUNTARY RECALL DEROYAL HOT/COLD THERAPY UNIT" letter dated September 17, 2013. The letter identified the product, problem, and actions to be taken by the customers.
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
The unit displays an error code of hose kinking when no hose kink is present; the unit fails to monitor the temperature of the water in the blanket as intended and controlling it through the automatic temperature control. this failure could result in temperature injuries to the treatment site; and there have been two reports of electric shock.
Acción
DeRoyal sent a "URGENT VOLUNTARY RECALL DEROYAL HOT/COLD THERAPY UNIT" letter dated September 17, 2013. The letter identified the product, problem, and actions to be taken by the customers.
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
Component, external, limb, ankle/foot - Product Code ISH
Causa
Ossur inititated a voluntary recall of the a-642100 fixed offset adapter because it can develop fatigue cracks in normal use over an extended period of time and ultimately separate completely.
Acción
Ossur sent an "Safety Notice Voluntary Product Recall" letter dated October 29, 2013, via regular mail. Follow-up telephones are also made. The letter identified the product the problem and the actions to be taken by the customer.
¿ssur is committed to providing superior customer service and we will do our utmost to minimize any inconvenience this may cause your practice. To ensure patient safety we kindly ask you to take the following action:
" Please identify the users of each of the A-642100 adapters, see attached list.
" Also, please check your inventory for any A-642100s you may have on hand but have not fitted on users.
A follow-up phone call will be made a few days later to coordinate replacements. A new replacement component will be provided to the customer.
For further questions please call (949) 360-3634.
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, mechanical - Product Code IOR
Causa
The potential exists for the wheel to rotate freely despite engagement of hub brake.
Acción
Invacare sent an URGENT: RECALL INFORMATION Letter dated September 10, 2012 to all affected customers. The letter identified the affected product, problem and actions to be taken. The letter instructed customers to
1) Complete the Provider Response Card indicating your receipt and understanding of these instructions. 2) Contact your customers to inform them of the recall. It is recommended that you provide them with the enclosed Customer Letter. Set up an appointment to correct the customer's wheelchair as soon as possible. 3) Please examine the wheelchair to confirm it has one of the serial numbers listed above. The serial number can be found on the front lower crossbar located on the right while sitting in the chair. 4) Using the enclosed retrofit kit, make the necessary correction. Installation instructions can be found on page 109 of the Solara service manual, which is enclosed.
5) Document the correction of the wheelchair on the enclosed tracking sheet.
6) Using the enclosed pre-paid UPS mailing label and original box, return the replaced parts to the address listed on the label. 7) Fax or email the Provider Response Form and tracking sheet to 330-329-3458 or recall@invacare.com. For questions please contact Invacare Customer Service at 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.
iWalk notified customers directly by sales representatives by telephone on October 26, 2012, and instructedthem to stop use of the battery and charger and return them to iWalk. Accounts provided with Return Material Authorizations (RMA).
For questions regarding this recall call 781-761-1560.
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.
Quasar bio-tech is recalling their baby quasar, baby quasar pink, quasar power pack, and quasar md because the device is unapproved.
Acción
The firm, Quasar Bio-Tech, sent an "URGENT: MEDICAL DEVICE RECALL" letter dated November 16, 2012 to its customers. All domestic customers were notified by Certified mail. The letter described the product, problem and actions to be taken. The customers were instructed to cease distribution and remove the products from sale; to complete and return the enclosed Response Form via e-mail to DeNette@quasarbiotech.com or fax to: Quasar Bio-Tech, Attn: Quality/Recall Coordinator: at 941-306-5816, and return all remaining stock to Quasar Bio-Tech at Quasar Bio-Tech Inc., Attn: Quality/Recall Coordinator, 1431 Tallevast Road, Sarasota FL 34243.
If you have any questions, contact the Quality/Recall Coordinator at 941-306-5812, Monday-Friday from 9:00 am to 5:00 pm Eastern Standard 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.
Quasar bio-tech is recalling their baby quasar, baby quasar pink, quasar power pack, and quasar md because the device is unapproved.
Acción
The firm, Quasar Bio-Tech, sent an "URGENT: MEDICAL DEVICE RECALL" letter dated November 16, 2012 to its customers. All domestic customers were notified by Certified mail. The letter described the product, problem and actions to be taken. The customers were instructed to cease distribution and remove the products from sale; to complete and return the enclosed Response Form via e-mail to DeNette@quasarbiotech.com or fax to: Quasar Bio-Tech, Attn: Quality/Recall Coordinator: at 941-306-5816, and return all remaining stock to Quasar Bio-Tech at Quasar Bio-Tech Inc., Attn: Quality/Recall Coordinator, 1431 Tallevast Road, Sarasota FL 34243.
If you have any questions, contact the Quality/Recall Coordinator at 941-306-5812, Monday-Friday from 9:00 am to 5:00 pm Eastern Standard 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.
Quasar bio-tech is recalling their baby quasar, baby quasar pink, quasar power pack, and quasar md because the device is unapproved.
Acción
The firm, Quasar Bio-Tech, sent an "URGENT: MEDICAL DEVICE RECALL" letter dated November 16, 2012 to its customers. All domestic customers were notified by Certified mail. The letter described the product, problem and actions to be taken. The customers were instructed to cease distribution and remove the products from sale; to complete and return the enclosed Response Form via e-mail to DeNette@quasarbiotech.com or fax to: Quasar Bio-Tech, Attn: Quality/Recall Coordinator: at 941-306-5816, and return all remaining stock to Quasar Bio-Tech at Quasar Bio-Tech Inc., Attn: Quality/Recall Coordinator, 1431 Tallevast Road, Sarasota FL 34243.
If you have any questions, contact the Quality/Recall Coordinator at 941-306-5812, Monday-Friday from 9:00 am to 5:00 pm Eastern Standard 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
Chair, with casters - Product Code INM
Causa
On 10/17/2011 winco mfg. llc, ocala, fl initiated a recall of the premier lifecare recliner and premier care recliner models 5400 and 5570 distributed between january 4, 2011 and october 12, 2011. the position lock pin(s) could potentially fail if exposed to excessive force when the chair is in the locked recline position. this failure will result in an inoperable position lock bar feature.
Acción
Winco Mfg. sent a "POSITION LOCK PIN RECALL NOTIFICATION" letter dated October 24 , 2011 to all affected customers. The letter describes the product, problem, and actions to be taken by the customers. The letter instructs customers to complete and return an enclosed response form and provide product disposition. Winco will ship retro-fit parts to install on the affected product. Instructions will explain step by step, how to implement the fix. Contact Winco at 800-237-3377 for questions regarding this recall.
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
Chair, with casters - Product Code INM
Causa
On 10/17/2011 winco mfg. llc, ocala, fl initiated a recall of the premier lifecare recliner and premier care recliner models 5400 and 5570 distributed between january 4, 2011 and october 12, 2011. the position lock pin(s) could potentially fail if exposed to excessive force when the chair is in the locked recline position. this failure will result in an inoperable position lock bar feature.
Acción
Winco Mfg. sent a "POSITION LOCK PIN RECALL NOTIFICATION" letter dated October 24 , 2011 to all affected customers. The letter describes the product, problem, and actions to be taken by the customers. The letter instructs customers to complete and return an enclosed response form and provide product disposition. Winco will ship retro-fit parts to install on the affected product. Instructions will explain step by step, how to implement the fix. Contact Winco at 800-237-3377 for questions regarding this recall.
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
Chair, with casters - Product Code INM
Causa
A supplier manufacturing assembly defect with the right hand recline mechanism. use of this product may result in the loss of functionality of the three (3) position lock bar when in a reclined position.
Acción
Winco sent a Recliner Field Correction Notification letter dated September 11, 2013 to all affected consignees. The letter identified the product, the problem and action to be taken by the consignees. The consignees were instructed to complete and return the enclosed field correction response form back to Winco so they can send replacement mechanism(s) along with instructions on how to exchange the mechanism(s). Customers with questions were instructed to contact Customer Care at 800-237-3377 or email QA-RA@wincomfg.com.
For questions regarding this recall call 352-854-2929, ext 130.