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
Ventilator, continuous, facility use - Product Code CBK
Causa
A component on the systems power board can fail in a manner which can cause the ventilator to shut down without alarming.
Acción
eVent Medical sent an Urgent Field Safety Notice dated October 12, 2015, to all affected customers on October 13, 2015, to inform them that eVent Medical is recalling Inspiration Ventilators i Series and LS 12.1 LCD because a component on the systems power board can fail in a manner which can cause the ventilator to shut down without alarming. The letter provides the customers with the problems identified and the actions to be taken. Customers with questions are instructed to call (949) 900-1917, x232.
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 inserter inner shaft would not fit through the inserter. the inner diameter of the cannulated shaft of the inserter was undersized.
Acción
Stryker Spine issued an "Urgent Product Removal Notifications /Customer Response Forms dated September 11, 2015. to all affected customers via Fed Ex priority overnight.
The notification instructed customers on how to identify affected product; the related issue with the affected product; potential hazards; risk mitigations; and actions needed to be taken. Customers were asked to examine their inventory and related hospital location inventories; and reconcile any UniVise Inserters with Catalog numbers and Lot numbers (referenced in the notification).
Customers were asked to fax a copy of the Customer Response Form to Regulatory Compliance (at 855-632-9049) or email it to Spine-RegulatoryActions@Stryker.com within 5 days of receipt of the notification.
For further questions please call (201) 760-8346.
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.
Stryker orthopaedics has received two customer complaints regarding duracon tibial wedge implants puncturing the packaging's tyvek lid(s).
Acción
On September 18, 2015, Stryker notified their Branches/Agencies of their action via email. The Branches/Agencies were instructed to quarantine affected devices. Urgent Medical Device Recall Notification Letters/Urgent Medical Device Recall Notification Acknowledgement Forms dated September 21, 2015 were sent to Branches/Agencies via UPS on 9/21/2015. Urgent Medical Device Recall Notification Letters/Urgent Medical Device Recall Notification Acknowledgement Forms dated September 21, 2015 were sent to Hospital Risk Managers via UPS on 9/23/2015.
The notification instructed consignees on how to identify affected product; the related issue with the affected product; potential hazards; risk mitigations; and actions needed to be taken. Consignees were asked to contact their Stryker Orthopaedics Sales Representative to arrange for return of any recalled product. Customers were asked to complete and return the attached Product Recall Acknowledgement Form within 5 days and either email (strykerortho7984@stericycle.com or Fax (1-866-672-0627) the response form back. A point of contact was provided in case the customer had any questions 201.831.5826.
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
Accessories,arthroscopic - Product Code NBH
Causa
The novocut suture manager device may cut the suture during knot tensioning and this may cause the suture knot to unravel.
Acción
Ceterix Orthopaedics sent an Urgent Field Safety notification letter dated October 13, 2015, to all affected sites. The product was identified, reason for recall explained and letter contains list of product lot numbers affected. Customers were instructed to identify and quarantine the affected product, contact Ceterix Orthopaedics to arrange a no cost return, and complete and return the attached acknowledgement form. Customers with questions were instructed to call 1-888-305-0615 or email: docs@ceterix.com. For questions regarding this recall call 650-396-3478.
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
Catheter, percutaneous - Product Code DQY
Causa
Medtronic has discovered that select lots of the amphirion deep pta balloon dilation catheter have a potential breach in the pouch seal enclosing the sterilized product.
Acción
Beginning October 23, 2015, Medtronic will send the customer letter and
confirmation form to all identified US customers via 2-day UPS mail delivery. Internationally, communications will be sent per locally approved methods.
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.
Six (6) pca 10 degree hooded acetabular insert-duration 22 mm (id) have been distributed in the us, although the 22 mm size was inadvertently omitted from 510(k) #k963612.
Acción
Stryker sent an Urgent Medical Device Recall Notification letter dated October 15, 2015, to all affected customers. The notification instructed consignees on how to identify affected product; the related issue with the affected product; potential hazards; risk mitigations; and actions needed to be taken. Customers were instructed to quarantine the affected product. Consignees were asked to complete and return the attached Product Recall Acknowledgement Form within 5 days and either email (strykerortho7984@stericycle.com or Fax (1-866-672-0627 ) the response form back. Customers with questions were instructed to call 201.831.5272.
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
Catheter, continuous flush - Product Code KRA
Causa
Cook medical has received six product complaints associated with reports of the 2.6fr curved catheter being mixed with the 4.0fr straight catheter and vice versa. investigation revealed the products were mixed
during processing.
Acción
Cook Medical sent an Urgent: Medical Device Recall letter dated October 20, 2015, to all affected customers via courier.
The recall notification included a description of the reason for the recall, affected product, customer responsibilities, and instructions for responding to the formal recall notification.
Should you have any questions or concerns, please do not hesitate to contact Cook Medical Customer Relations at 1-800-457-4500 or 1-812-339-2235.
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 products have been found to intermittently exhibit a seal failure during use.
Acción
The recalling firm issued a press release on 10/28/2015. The press release was posted on FDA website on 10/29/2015. The recalling firm emailed affected consignees on 10/28/15 and sent out recall letters via USPS beginning 10/30/15.
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.
Civco Medical Solutions sent an Urgent Medical Device Recall letter dated October 19, 2015, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to return all affected needle guides. If the needle guide is contained within a kit, only the needle guide from the kit needs to be returned. The communication contains a response form to be completed and returned by the customer. The customer filling out the response form is asked to acknowledge receipt of the recall notice and indicate the number and type of affected product they are returning. Customers withh questions were instructed to call 800-445-6741 or 319-248-6757 or email order@civco.com.
For questions regarding this recall call 319-248-6502.
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.
Civco Medical Solutions sent an Urgent Medical Device Recall letter dated October 19, 2015, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to return all affected needle guides. If the needle guide is contained within a kit, only the needle guide from the kit needs to be returned. The communication contains a response form to be completed and returned by the customer. The customer filling out the response form is asked to acknowledge receipt of the recall notice and indicate the number and type of affected product they are returning. Customers withh questions were instructed to call 800-445-6741 or 319-248-6757 or email order@civco.com.
For questions regarding this recall call 319-248-6502.
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
Screw, fixation, bone - Product Code HWC
Causa
Scfe driver's threaded shaft broke close to the knob when a manual force was applied during the fixation of the screw.
Acción
The firm sent the Urgent Field Safety Notice-Recalls to US consignees via email. Consignees are advised to return affected devices back to the firm.
Customer with questions can contact Enrique Garcia at 450-688-5144 ext. 242 or send email to egarcia@pegamedical.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.
Civco Medical Solutions sent an Urgent Medical Device Recall letter dated October 19, 2015, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to return all affected needle guides. If the needle guide is contained within a kit, only the needle guide from the kit needs to be returned. The communication contains a response form to be completed and returned by the customer. The customer filling out the response form is asked to acknowledge receipt of the recall notice and indicate the number and type of affected product they are returning. Customers withh questions were instructed to call 800-445-6741 or 319-248-6757 or email order@civco.com.
For questions regarding this recall call 319-248-6502.
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.
Civco Medical Solutions sent an Urgent Medical Device Recall letter dated October 19, 2015, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to return all affected needle guides. If the needle guide is contained within a kit, only the needle guide from the kit needs to be returned. The communication contains a response form to be completed and returned by the customer. The customer filling out the response form is asked to acknowledge receipt of the recall notice and indicate the number and type of affected product they are returning. Customers withh questions were instructed to call 800-445-6741 or 319-248-6757 or email order@civco.com.
For questions regarding this recall call 319-248-6502.
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
Immunohistochemical reagent, antibody (monoclonal or polyclonal) to p63 protein in nucleus of prosta - Product Code NTR
Causa
It was discovered that the labeling of ms-230 antibody incorrectly describes the concentration - label reads 0.2mg/ml but it is actually 0.4 mg/ml.
Acción
The firm, ThermoFisher Scientific, sent an "URGENT MEDICAL DEVICE RECALL-Lab Vision Corporation" letter dated 10/29/2015 to its customers on 10/30/2015. The letter describes the product, problem and actions to be taken. The customers were instructed to Upon identification of the affected lot, notify Lab Vision of the quantity previously used and the quantity still in inventory; review any associated test results to ensure an accurate diagnosis was able to be made; If routine laboratory use of this product follows the Lab Vision Data Sheet, the antibody may safely be used as is; hold any affected material in quarantine until the new labels are received-affected product may also be returned to Lab Vision, and complete and return the attached Recall Return Response Acknowledgement & Receipt Form via email to: sarah.rickert@thermofisher.com or Fax to: 269-372-2674, Attn: Quality Assurance & Regulatory Affairs Manager.
A new label with the correct concentration can be sent upon request, for relabeling of the product at the customers facility.
If you have any questions, please contact Quality Assurance & Regulatory Affairs Manager at 269-544-5628 or sarah.rickert@thermofisher.com.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notas adicionales en la data
Wire, guide, catheter - Product Code DQX
Causa
Microcatheter may have circumferential defects (cracks) along its shaft.
Acción
Recall notification letter was sent to affected consignees on 10/28/2015 via courier. The letter contained a fax-back form to be completed by the consignee and sent to the quality department of the recalling firm.
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.
Incorrect use of t-piece resuscitators will result in complete occlusion of the patient circuit and consequent failure to ventilate the patient.
Acción
Mercury Medical sent notification letters dated October 22, 2015, to all affected Domestic Consignees by courier and for the foreign consignees the notifications were sent via e-mail.
The letter identified the product, the problem, and the action to be taken by the consignee.
Customer Immediate Actions - Immediately notify all personnel subject to using these devices to remove protective cap before connecting a mask. Further this filed safety advisory notice should be read in conjuction with the manufacturer supplied instructions for use.
In addition, if you further distributed this product, please identify your customers and notify them at once of this product correction. Notificatin to your customers should include a copy of this letter. For questions contact Mercury Medical at 787-573-0088, 727-573-4966 fax or via e-mail at regulatoryaffairs@mercurymed.com
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notas adicionales en la data
Motor, drill, pneumatic - Product Code HBB
Causa
The wire pass hole is not present on the tools.
Acción
A recall letter was mailed to consignees on October 21, 2015.
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
Antigens, Febrile, Slide And Tube, All Groups, Salmonella Spp. - Product Code GNC
Causa
Febrile antigens and control antisera that were released prior to august 2003 contained the 12/2000 revised insert that had incorrect testing instructions.
Acción
Consignees were notified by letter beginning 10/20/2004.
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
Dialyzer, high permeability with or without sealed dialysate system - Product Code KDI
NxStage issued issued a Field Safety Notice (FSN) on 10/29/15 to consignees who have NX1000-5 or a NX1000-5-A cycler. The FSN included Instructions for steps to be taken so that the cycler and treatments are not affected by the software error.
NxStage will be sending a representative to the facility to attach detailed instructions on each cycler as a user reference. Return the attached reply form to acknowledge receipt of this letter.
Questions or comments, please contact NxStage Customer Service at 1-866-NXSTAGE (1-866-697-8243).
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
Dialyzer, high permeability with or without sealed dialysate system - Product Code KDI
NxStage issued issued a Field Safety Notice (FSN) on 10/29/15 to consignees who have NX1000-5 or a NX1000-5-A cycler. The FSN included Instructions for steps to be taken so that the cycler and treatments are not affected by the software error.
NxStage will be sending a representative to the facility to attach detailed instructions on each cycler as a user reference. Return the attached reply form to acknowledge receipt of this letter.
Questions or comments, please contact NxStage Customer Service at 1-866-NXSTAGE (1-866-697-8243).
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
Reagents,specific,analyte - Product Code MVU
Causa
Three lots of cd64 (md22) are contaminated with cd4 antibody.
Acción
Urgent Product Recall letters were sent out on October 30, 2015 via certified mail to notify customers of the issue.
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.
This recall is being initiated due to a potential breach of the tubing pack header bags manufactured in these select lots. the seal in question is between the tyvek and the poly side of the header bag.
Acción
Medtronic sent an Urgent Medical Device Recall letter dated October 2015 to all affected consignees. The letter described the problem and the product involved in the recall. Consignees were advised to quarantine and return all affected product and to complete and return the Customer Confirmation certificate. For questions contact your Medtronic representative or contact Medtronic's national Answering service at 800-633-8766.
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.
Implant direct sybron manufacturing, llc is recalling 26 lots of dgde directguide drill extender because of a possible dropping of the drill.
Acción
On 10/28/15 customer notification letters were sent.
Within the letter the firm states that if customers have any of the affected product listed to contact the firm's Customer Care at 1-888-649-6425. A return label is provided with notification.
The firm states that if customers are an authorized Implant Direct Sybron Manufacturing distributor they request that they identify their customers that have been shipped the affected product, and contact them within 48 hours of receiving notification in order to obtain the product.
The letter states if any customers or patients have experienced any issues as a result of the affected products to report the incident to the FDA through he MEDWATCH reporting system.
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 lot number on the outer carton label did not match the lot number printed on the tray label or identification labels inside the box. the identification labels inside the box are placed on medical records and other documents associated with the procedure. use of incorrectly identified labels may prevent direct traceability of the implanted unit in the future.
Acción
Consignees were hand delivered by sales representatives a Astora Women's Health "Urgent Recall Notice". The letter was addressed to Physician, Health Care Professional, Nurse & Risk Manager. The letter described the problem and the product involved in the recall. Consignees were advised to check their inventory and return all affected product, notify those that might be affected and to complete and return the Acknowledgement Form. For questions contact ASTORA Women's Health Customer Service at 1-844-879-0787.
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
Dialyzer, high permeability with or without sealed dialysate system - Product Code KDI
Causa
Ultrafiltration volume (ufv) may not decrease during treatment-software error. the uf pump may continue to run and remove fluid even after the target uf volume has been removed.
Acción
NxStage issued a Field Safety Notice (FSN), dated October 29, 2015, to clinic and home patients with a NX1000-3 or NX1000-4 cycler. For patients performing short daily hemodialysis, the FSN included instructions for steps to be taken so that the cycler and treatments are not affected by the software error. Patients performing nocturnal hemodialysis were instructed to contact their Center for a replacement NX1000-1 Cycler. A software update will be released to correct the error. Customers should complete and return the reply form. Contact NxStage Customer Service at 1-866-NXSTAGE (1-866-697-8243) with questions or comments.