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
Needle, hypodermic, single lumen - Product Code FMI
Causa
Device failed to operate; the insertion of the infusion tube of the fastx sternal intraosseous device was not achieved in live subjects.
Acción
Pyng Medical Corp. sent a "FSN/RECALL FOR FASTx STERNAL INTRAOSSEOUS DEVICE, P/N FASTx -H" letter dated November 5, 2010 to all affected customers. The letter describes the product, problem, and the actions to be taken by the customers.
Customers are to cease distribution and use of all devices. All devices remaining in inventory should be quarantined. Customers are asked to complete the information at the bottom of the letter and return the product by FEDEx.
Questions regarding this notice should contact the Director of Operations at 1-604-303-7964 ext. 211.
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.
Medtronic sent a Voluntary Recall letter dated June 28, 2011, directly to Risk Managers and Sales Representatives, with Recall Questionnaires and Confirmation forms included. The letter identified the product, the problem, and the action to be taken by the affected customers. If appropriate, personal follow up with Sales Representatives will be made to assure that the recall communication is understood by Risk Managers and to facilitate return of product and the associated Recall response documentation. Foreign consignees will be notified by email on June 29, 2011.
For any questions or concerns regarding this recall customers were to contact their Medtronic Sales Representative or the Global Quality Department at 800-876-3133, ext 3173.
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
Worldwide Distribution - USA (nationwide) and the countries of MN, AK, FL, PA, ME, GA HI, CA, TX, OH - Product Code KWP
Causa
Screws are longer then size etched on the screw.
Acción
Medtronic sent a Voluntary Recall letter dated June 28, 2011, directly to Risk Managers and Sales Representatives, with Recall Questionnaires and Confirmation forms included. The letter identified the product, the problem, and the action to be taken by the affected customers. If appropriate, personal follow up with Sales Representatives will be made to assure that the recall communication is understood by Risk Managers and to facilitate return of product and the associated Recall response documentation. Foreign consignees will be notified by email on June 29, 2011.
For any questions or concerns regarding this recall customers were to contact their Medtronic Sales Representative or the Global Quality Department at 800-876-3133, ext 3173.
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.
Medtronic sent a Voluntary Recall letter dated June 28, 2011, directly to Risk Managers and Sales Representatives, with Recall Questionnaires and Confirmation forms included. The letter identified the product, the problem, and the action to be taken by the affected customers. If appropriate, personal follow up with Sales Representatives will be made to assure that the recall communication is understood by Risk Managers and to facilitate return of product and the associated Recall response documentation. Foreign consignees will be notified by email on June 29, 2011.
For any questions or concerns regarding this recall customers were to contact their Medtronic Sales Representative or the Global Quality Department at 800-876-3133, ext 3173.
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
Appliance, fixation, spinal intervertebral body - Product Code KWP
Causa
Screws are longer then size etched on the screw.
Acción
Medtronic sent a Voluntary Recall letter dated June 28, 2011, directly to Risk Managers and Sales Representatives, with Recall Questionnaires and Confirmation forms included. The letter identified the product, the problem, and the action to be taken by the affected customers. If appropriate, personal follow up with Sales Representatives will be made to assure that the recall communication is understood by Risk Managers and to facilitate return of product and the associated Recall response documentation. Foreign consignees will be notified by email on June 29, 2011.
For any questions or concerns regarding this recall customers were to contact their Medtronic Sales Representative or the Global Quality Department at 800-876-3133, ext 3173.
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
Thermal Regulating System - Product Code DWJ
Causa
Due to its design the circuit breaker on the device could trip causing it to shut down and not provide heated air to the blanket.
Acción
Cincinnati Sub-Zero Products, Inc. sent an 'URGENT Medical Device Recall Field Action Notice" dated July 12, 2011 to all affected customers.
The letter includes: description of product, problem, and information to request a repair tubing kit free of charge. It also asks customers to complete and return a "Recall Response Form".
For additional information e-mail WA135-2011@cszinc.com or call (800) 989-7373 or (513) 772-8810.
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
Marker, radiographic, implantable - Product Code NEU
Causa
During an fda inspection on 3/21/11 - 3/22/11 at kapp surgical an uncontrolled instruction for use was discovered which contained sterilization parameters which differed from the instructions contained in the device master record. kapp surgical decided to conduct the recall because we cannot be sure that incorrect instructions were not shipped.
Acción
Kapp Surgical Instrument, Inc. sent an "URGENT MEDICAL DEVICE RECALL" letter dated May 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 check their inventory and quarantine any product affected by this recall. The firm will make arrangements for returning the products. Replacements will be made by Kapp Surgical.
Questions about this recall are directed to the QA Manager at 800-282-5277.
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
Intraocular lens - Product Code HQL
Causa
The recall was initiated by staar surgical due to an error in the directions for use (dfu) for staar surgical's collamer ultraviolet absorbing posterior chamber single piece foldable intraocular lens (collamer ip iol), also
known as the nanoflex iol. the device description erroneously indicates that the lens could be
implanted in the ciliary sulcus.
Acción
Staar Surgical send out an URGENT - Medical Device Correction Notice to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were asked to acknowledge receipt of the letter by signing, dating, and faxing the form to Staar Surgical.
For any questions call (800) 292-7902, ext 2345.
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 packaging may not have been properly sealed, and therefore the sterility of the product cannot be guaranteed.
Acción
Teleflex Medical sent an "URGENT MEDICAL DEVICE RECALL NOTIFICATION" letter dated June 6, 2011 to all affected customers. The letter described the product, problem, and the action to be taken.
The letter instructs customers to discontinue use and quarantine the affected product. Customers must complete and return a Recall Acknowledgement Form via fax to 1-866-804-9881, Attn: Customer Service. A representative will contact customers with instructions on how to return the affected product. Customers with no affected product are also instructed to complete and return the form to verify receipt of the notification.
Contact Customer Service at 1-866-246-6990 if you have questions regarding this recall.
and a record of returns. A third letter was addressed to the Risk Manager with the above instructions.
Cuban data is current through 2018. All of the data comes from the Health Ministry of Cuba, except for the categories Manufacturer Parent Company and Product Classification.
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, based on matches of recall data from the U.S. and Cuba.
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, blood culturing - Product Code MDB
Causa
Software contained three additional set configurations which caused the system to reinitialized the ast set carrier defaults.
Acción
BD Diagnostic Systems verbally notified all affect customers via the telephone on March 28, 2011. The notification identified the product, the problem, and the action to be taken by the customer. An "URGENT PRODUCT RECALL" follow-up letter was mailed to all customers on April 8, 2011 via UPS. Customers were instructed to complete and fax the attached reply form to acknowledge their receipt of the notification to Regulatory Compliance, 410-316-4256. The letter instructs customers to refer to the modified release notes and IMPORTANT NOTICES outlined in the attached notification letter.
If further assistance is needed regarding replacements and all other inquires, please contact BD Technical Services and Support at 1-800-638-8663.
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.
Speakers on the suresigns patient monitors and vital signs, failure may be identified by the display of a speaker malfunc message in the alarm message area or an audio failed message in the main screen of the device or by the absence of audible sound.
Acción
Philips Healthcare sent an "URGENT MEDICAL DEVICE CORRECTION" letter dated May 2011 to all affected customers. The letter identifies the products, problem, and actions to be taken.
The letter states that customers may continue to use the affected products while awaiting replacement of the speaker, provided that the user routinely checks for the display of the "Speaker Malfunct." INOP. Additionally, the letter states that if the customer experience this INOP or there is no sound from the SureSigns Monitor, the customer is to remove the device from use and contact their local Philips service representative.
The letter explains that Philips is completing the design for a replacement speaker assembly, which is expected to be available within 8 weeks. When available, Philips will replace the affected speaker assemblies free of charge.
Customers are instructed to contact their local Philips Customer Care Center at 1-800-722-9377 if further information or support is required.
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
Electrocardiograph - Product Code DPS
Causa
Speakers on the suresigns patient monitors and vital signs, failure may be identified by the display of a speaker malfunc message in the alarm message area or an audio failed message in the main screen of the device or by the absence of audible sound.
Acción
Philips Healthcare sent an "URGENT MEDICAL DEVICE CORRECTION" letter dated May 2011 to all affected customers. The letter identifies the products, problem, and actions to be taken.
The letter states that customers may continue to use the affected products while awaiting replacement of the speaker, provided that the user routinely checks for the display of the "Speaker Malfunct." INOP. Additionally, the letter states that if the customer experience this INOP or there is no sound from the SureSigns Monitor, the customer is to remove the device from use and contact their local Philips service representative.
The letter explains that Philips is completing the design for a replacement speaker assembly, which is expected to be available within 8 weeks. When available, Philips will replace the affected speaker assemblies free of charge.
Customers are instructed to contact their local Philips Customer Care Center at 1-800-722-9377 if further information or support is required.
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
Ligator, Esophageal - Product Code MND
Causa
The disposable clip may not deploy after being positioned inside the patient.
Acción
Wilson-Cook Medical, Inc. (Cook Endoscopy) sent an "URGENT: PRODUCT RECALL" notice dated June 7, 2011 and a "PRODUCT RECALL EFFECTIVENESS SURVEY' dated June 21, 2011 to all affected consignees. The notice described the product, problem, and actions to be taken. Medical users were instructed to quarantine any affected products and return to Cook Medical. The distributors were instructed to contact their customers and coordinate the return of the affected products to Cook Medical. The recalled notice and survey should be completed and returned to Cook Medical via fax to 812-339-7316 or scanned and emailed to CustomerRelationsNA@cookmedical.com. If you have any questions regarding this matter, please contact the Customer Relations Department at toll free-1-800-457-4500, press 4 then enter extension 2146 or by email at CustomerRelationsNA@cookmedical.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.
The gap between the two parts of the table may permit pinches to occur on either patient's skin or other body parts; it has the potential for serious injury if a patient's finger is caught between the pallet and patient table resulting in broken finger bone.
Acción
Philips Healthcare issued a Customer Information letter (Field Change Order (#88200402)) dated June 15, 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 follow the instruction for use for their system, which states "Monitor the patient and the system vigilantly during any system motions to make sure that ...accessories, equipment, and all ojbects such as hair, jewelry, or neckties-remain clear of any moving camera and imaging table parts. For additional information, customers were istructed to see the BrightView SPECT instructions for Use, section 2.2 - Safety Warnings and Precautions and Safety and Information Labels.
Philips Healthcare will notify all affected customers and will install a sticker through an Action for Performance - Proactive Field Change Order (FCO) to resolve the issue.
For customers in North America who require further information or support contact Customer Care Solutions Center at 1-800-722-9377, Select Option 5.
In all other countries the local Philips Healthcare office should be contacted.
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.
Some units were manufactured with a defective humidifier chamber o-ring. unit could leak, allowing water to escape during use, causing damage to furniture.
Acción
The firm, DeVilbiss Healthcare, issued a "URGENT: MEDICAL DEVICE CORRECTION" letter dated March 11, 2011 to its customers. The letter described the product, problem, and actions to be taken. The customers were instructed to verify their inventory of CPAPs with Heated Humidifiers and isolate any units that are included in the list; replace the humidifier chamber o-rings with the new ones provided; discard the original o-ring removed from the humidifier chamber; complete and return the URGENT: MEDICAL DEVICE CORRECTION Confirmation letter via mail to Quality Manager, DeVilbiss Healthcare LLC, 100 DeVilbiss Drive, Somerset, PA, 15501; affirm that all units have been corrected and that all end users have been sent replacement parts, when all of the CPAPs on the serial number list have been corrected, and return a copy of the sign serial number sheet as confirmation.
If you have any questions regarding the information provided in this communication, please contact DeVilbiss Healthcare Customer Service at 1-800-388-1988 from 8:00AM-5:00PM EST.
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
Arthroscope - Product Code HRX
Causa
On 01/26/2009, ascent healthcare solutions, lakeland, fl initiated a recall of various models of dyonics, stryker, and linvatech reprocessed arthroscopic shaver blades. the sterility of the devices may be compromised due to a potential breach in the seal of the tyvek cover to the plastic tray.
Acción
Ascent Healthcare Solutions sent an "URGENT MEDICAL DEVICE VOLUNTARY RECALL" letter dated January 26, 2009 to all affected customers. The letter describes the product, problem, and actions to be taken by the customers. Customers were instructed to examine their inventory, remove and quarantine all affected devices. A Recall Effectiveness Check Form was attached for customers to complete and return via fax to 1-866-325-4760. Contact the firm at (888) 888-3433 ext. 5519 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
Arthroscope - Product Code HRX
Causa
On 01/26/2009, ascent healthcare solutions, lakeland, fl initiated a recall of various models of dyonics, stryker, and linvatech reprocessed arthroscopic shaver blades. the sterility of the devices may be compromised due to a potential breach in the seal of the tyvek cover to the plastic tray.
Acción
Ascent Healthcare Solutions sent an "URGENT MEDICAL DEVICE VOLUNTARY RECALL" letter dated January 26, 2009 to all affected customers. The letter describes the product, problem, and actions to be taken by the customers. Customers were instructed to examine their inventory, remove and quarantine all affected devices. A Recall Effectiveness Check Form was attached for customers to complete and return via fax to 1-866-325-4760. Contact the firm at (888) 888-3433 ext. 5519 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.
Medacta international has recently realized that the base of the liner inserter ref 01.26.10.0018
lot 105549 of the versafitcup double mobility system could become rusty after the washing
procedures. this is due to an incorrect raw material used by one of our suppliers during the
production phase of this lot. for this reason, medacta international has made the decision to
remove all the pieces.
Acción
Medacta USA sent an "URGENT SAFETY NOTIFICATION-VERSAFITCUP DM LINER INSERTER" letter dated May 23, 2011 to all affected customers. The letter describes the product, problem, and the actions to be taken by the customers.
The letter instructs customers to check their inventory for the affected device, immediately sequester it and not use the device in surgery. The letter instructs customers to pack the affected device for shipment to Medacta USA under Return Material Authorization 1590. Customer will receive a replacement within a few days.
Questions regarding this recall are directed to the Director of Regulatory and Quality at 805-437-7085 ext. 26.
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
Wire, guide, catheter - Product Code DQX
Causa
Baloon catheter guidewires may become uncoiled during angioplasty procedures.
Acción
Terumo Medical Corporation initiated contacting consignees on June 3, 2011 via an in-person visit to hand deliver an "URGENT PRODUCT BULLETIN: TERUMO PRODUCT SAFETY ALERT" letter dated June 3, 2011. The letter emphasized to consignees the importance of following the current instructions and recommendations provided to minimize the potential for damage during use and removal of the recalled product. For further questions, please contact your Terumo Territory Manager or call (800) 283-7866 and ask to speak with the Runthrough NS Guidewire Product Manager, at extension 4129.
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
Electrode, cutaneous - Product Code GXY
Causa
Premature device failure : failure of the electrode sites to conduct and provide muscle stimulation due to silver fabric component failure.
Acción
Axiobionics, LLC is notifying all affected customers by phone. Three attempts will be made to contact the customer by phone. Contact by telephone will be made to prescribing physician to determine if Axiobionics has latest patient contact information. If information is different, new contact information will be recorded and 3 additional attempts will be made with the new information.
If the patient cannot be reached by telephone, a certified letter will be sent to the patient's address. If contacting by mail, the letter template will be provided to the FDA recall office .
All patients should have been contacted by telephone, certified mail, or in person by June 10, 2011.
All patients affected by the field correction will be asked the following questions to determine if their electrodes are functional and resistances are not exceeding the output capabilities of the stimulator they are using.
1. Are you using your garment?
2. Is your garment delivering the stimulation required for your therapy?
3. If the patient is using an NP4 stimulator: What are the resistance readings on each channel?
4. If the patient answers No to question 2 or states that the resistance is reading greater than 200 ohms on at least one channel in question 3, the garments will be returned to Axiobionics for repair.
Garments that are not functioning correctly will be repaired first. Functioning garments will be tested by immersion into a salt bath under the given protocol to determine if the silver fabric is properly coated.
Questions regarding this correction should be directed to the Axiobionics representative at 800-552-3539.
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
Electrode, cutaneous - Product Code GXY
Causa
Premature device failure : failure of the electrode sites to conduct and provide muscle stimulation due to silver fabric component failure.
Acción
Axiobionics, LLC is notifying all affected customers by phone. Three attempts will be made to contact the customer by phone. Contact by telephone will be made to prescribing physician to determine if Axiobionics has latest patient contact information. If information is different, new contact information will be recorded and 3 additional attempts will be made with the new information.
If the patient cannot be reached by telephone, a certified letter will be sent to the patient's address. If contacting by mail, the letter template will be provided to the FDA recall office .
All patients should have been contacted by telephone, certified mail, or in person by June 10, 2011.
All patients affected by the field correction will be asked the following questions to determine if their electrodes are functional and resistances are not exceeding the output capabilities of the stimulator they are using.
1. Are you using your garment?
2. Is your garment delivering the stimulation required for your therapy?
3. If the patient is using an NP4 stimulator: What are the resistance readings on each channel?
4. If the patient answers No to question 2 or states that the resistance is reading greater than 200 ohms on at least one channel in question 3, the garments will be returned to Axiobionics for repair.
Garments that are not functioning correctly will be repaired first. Functioning garments will be tested by immersion into a salt bath under the given protocol to determine if the silver fabric is properly coated.
Questions regarding this correction should be directed to the Axiobionics representative at 800-552-3539.
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
Electrode, cutaneous - Product Code GXY
Causa
Premature device failure : failure of the electrode sites to conduct and provide muscle stimulation due to silver fabric component failure.
Acción
Axiobionics, LLC is notifying all affected customers by phone. Three attempts will be made to contact the customer by phone. Contact by telephone will be made to prescribing physician to determine if Axiobionics has latest patient contact information. If information is different, new contact information will be recorded and 3 additional attempts will be made with the new information.
If the patient cannot be reached by telephone, a certified letter will be sent to the patient's address. If contacting by mail, the letter template will be provided to the FDA recall office .
All patients should have been contacted by telephone, certified mail, or in person by June 10, 2011.
All patients affected by the field correction will be asked the following questions to determine if their electrodes are functional and resistances are not exceeding the output capabilities of the stimulator they are using.
1. Are you using your garment?
2. Is your garment delivering the stimulation required for your therapy?
3. If the patient is using an NP4 stimulator: What are the resistance readings on each channel?
4. If the patient answers No to question 2 or states that the resistance is reading greater than 200 ohms on at least one channel in question 3, the garments will be returned to Axiobionics for repair.
Garments that are not functioning correctly will be repaired first. Functioning garments will be tested by immersion into a salt bath under the given protocol to determine if the silver fabric is properly coated.
Questions regarding this correction should be directed to the Axiobionics representative at 800-552-3539.
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
Electrode, cutaneous - Product Code GXY
Causa
Premature device failure : failure of the electrode sites to conduct and provide muscle stimulation due to silver fabric component failure.
Acción
Axiobionics, LLC is notifying all affected customers by phone. Three attempts will be made to contact the customer by phone. Contact by telephone will be made to prescribing physician to determine if Axiobionics has latest patient contact information. If information is different, new contact information will be recorded and 3 additional attempts will be made with the new information.
If the patient cannot be reached by telephone, a certified letter will be sent to the patient's address. If contacting by mail, the letter template will be provided to the FDA recall office .
All patients should have been contacted by telephone, certified mail, or in person by June 10, 2011.
All patients affected by the field correction will be asked the following questions to determine if their electrodes are functional and resistances are not exceeding the output capabilities of the stimulator they are using.
1. Are you using your garment?
2. Is your garment delivering the stimulation required for your therapy?
3. If the patient is using an NP4 stimulator: What are the resistance readings on each channel?
4. If the patient answers No to question 2 or states that the resistance is reading greater than 200 ohms on at least one channel in question 3, the garments will be returned to Axiobionics for repair.
Garments that are not functioning correctly will be repaired first. Functioning garments will be tested by immersion into a salt bath under the given protocol to determine if the silver fabric is properly coated.
Questions regarding this correction should be directed to the Axiobionics representative at 800-552-3539.
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.
Recalled device was packaged with the incorrect angled blade. the labeling indicates a 12 degree angle but the product has a 40 degree angle.
Acción
Stryker Instruments Division of Stryker CorporationOn 6/13/11 sent an 'URGENT MEDICAL DEVICE RECALL NOTIIFICATION" letter to all affected customers that included the device name, lot number, dates of distribution, reason for the recall, risks associated with use of the device, a photo of the device, instructions to quarantine and return the devices, and a form to fax back to the firm to confirm receipt and adherence to the recall letter.