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, balloon, intra-aortic and control - Product Code DSP
Causa
Potential to have an internal leak at the fill port of the stainless steel tip, which may necessitate removal and replacement of
the catheter.
Acción
Arrow International issued Urgent Medical Device Recall notification on 11/27/12. The letter identified the affected product and the reason for the recall. Accounts are requested to check their stock for the products included within the scope of this recall. Also, customers should cease use and distribution, and quarantine all affected product immediately. Contact Arrow's Customer Service Department at 800-523-8446 for a Return Authorization
Number. Customers are to complete and fax the Recall Acknowledgement & Stock Status Form to the number provided, and return the affected product. If customers have questions or need clarification regarding this issue, they should contact Arrow's Customer Service Department at 1-800-523-8446.
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 cassettes were shipped with the wrong ip (image plate) size bar code.
Acción
On February 7, 2013, AGFA called dealers involved to alert them of the safety issue. Also, an 'URGENT FIELD SAFETY NOTICE" letter dated February 26, 2013 was sent to the customers. The letter described the affected product, problem and actions to be taken. Customers were requested to check their inventories for the affected product and block any identified product within their inventory. Customers were instructed to complete the attached Feedback form and return via FAX or email. For questions call 877-777-2432 Prompt 5.
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.
Leep redikit products (for use in loop electrosurgical excision procedures) have xylocaine (lidocaine) hcl (2%) listed on the tray lid label but this is not included in the contents of the kit, which contained polocaine (mepivacaine) hcl (3%) instead (which was not listed on the tray label).
Acción
CooperSurgical sent a Recall Notification dated February 26, 2013, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer.
CSI intends to track and quarantine returned product in a segregated location at its manufacturing facility to ensure its separation from acceptable product and prevent its misuse. CSI intends to render used product useless by physical destruction and to rework unused product by correcting the labeling for redistribution.
If you have any one of these affected lot numbers in your current inventory, please contact our Customer Service Department at 800-243-2974, or simply complete the attached form and fax to 800-262-0105. Arrangements will be made to replace product in your possession at CooperSurgical's expense. Further instruction and disposition of product will be communicated to you at that time.
CooperSurgical deeply regrets the inconvenience that this problem has caused.
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.
Internal testing found certain sarns" tcm ii systems were released with incorrectly assembled heatsink assemblies which could cause the units to fail.
Acción
Terumo sent beginning May 30, 2013, an URGENT MEDICAL DEVICE RECALL NOTIFICATION were sent to all customers with instructions to notify all customers of the recall requesting all affected units to be quarantined until the heatsink units are replaced Confirm receipt by filling out the response form containing communication by faxing or emailing the attached Affiliate Response Form to the fax number or email address indicated on the form.
Questions should be directed to Terumo CVS customer service in the U.S.:
Telephone: +1-734-663-4145; Fax: +1-734-741-6149
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
Pessary, vaginal - Product Code HHW
Causa
Pessary mislabeled outer package may not reflect the size of the product contained in the package.
Acción
Cooper Surgical initiateda recall by letter on February 26, 2013, advising accounts to examine inventory and report quantity back to the firm for replacement. For questions customers should call Customer Service at 1-800-243-2974.
For questions regarding this recall call 203-601-9825.
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
Pessary, vaginal - Product Code HHW
Causa
Pessary mislabeled outer package may not reflect the size of the product contained in the package.
Acción
Cooper Surgical initiateda recall by letter on February 26, 2013, advising accounts to examine inventory and report quantity back to the firm for replacement. For questions customers should call Customer Service at 1-800-243-2974.
For questions regarding this recall call 203-601-9825.
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
Pessary, vaginal - Product Code HHW
Causa
Pessary mislabeled outer package may not reflect the size of the product contained in the package.
Acción
Cooper Surgical initiateda recall by letter on February 26, 2013, advising accounts to examine inventory and report quantity back to the firm for replacement. For questions customers should call Customer Service at 1-800-243-2974.
For questions regarding this recall call 203-601-9825.
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
Pessary, vaginal - Product Code HHW
Causa
Pessary mislabeled outer package may not reflect the size of the product contained in the package.
Acción
Cooper Surgical initiateda recall by letter on February 26, 2013, advising accounts to examine inventory and report quantity back to the firm for replacement. For questions customers should call Customer Service at 1-800-243-2974.
For questions regarding this recall call 203-601-9825.
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
Pessary, vaginal - Product Code HHW
Causa
Pessary mislabeled outer package may not reflect the size of the product contained in the package.
Acción
Cooper Surgical initiateda recall by letter on February 26, 2013, advising accounts to examine inventory and report quantity back to the firm for replacement. For questions customers should call Customer Service at 1-800-243-2974.
For questions regarding this recall call 203-601-9825.
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
Pessary, vaginal - Product Code HHW
Causa
Pessary mislabeled outer package may not reflect the size of the product contained in the package.
Acción
Cooper Surgical initiateda recall by letter on February 26, 2013, advising accounts to examine inventory and report quantity back to the firm for replacement. For questions customers should call Customer Service at 1-800-243-2974.
For questions regarding this recall call 203-601-9825.
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, test, blood glucose, over the counter - Product Code NBW
Causa
Roche investigation into complaints found accu-chek inform ii and coaguchek xs pro system barcode reading meters had the potential of intermittent erroneous decoding of patient identification if barcodes being read fail to meet size and/or quality standards.
Acción
Consignees of both devices were notified by Urgent Medical Device Correction letters sent via UPS Ground (receipt required) beginning 3/06/2013. The notice contained recommendation not to use EAN-13 barcode system and ensure barcodes used meet quality standards; use operator and patient lists (downloaded from a data manager) in order to check any decoded identification against the respective list. The notice directed forwarding of the notice if the product was further distributed. Customers were asked to complete the attached fax form. Contact the Customer Care Service Center, 24 hours a day, seven days a week at 1-800-440-3638 for Accu check questions and 1-800-428-4674 for CoaguChek questions about the information contained in this UMDC.
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 defect in cas i/ii absorbers in the spacelabs anesthesia workstations and service kits may cause a condition leading to an increase in the carbon dioxide concentration within the inspired gas being delivered to the patient.
Acción
Spacelabs sent an URGENT-MEDICAL DEVICE CORRECTION letter, dated 16 January 2013, to all affected customers. The letter identified the affected product, problem and actions to be taken. The letter instructed customers until a Spacelabs representative replaces the affected product:
1) Immediately cease the use of BleaseSirius and BleaseFocus Anesthesia Workstations that shipped after 31 October 2012.
2) Immediately cease use of Service Kits Part Number 12200902, 050-0659-00 and 050-0901-00 and any workstation containing a CAS I/II Absorber from such Service Kit.
3) Advise your staff of this situation
Customers can call Spacelabs Healthcare at 1-800-522-7025 and select 2 for Technical support.
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
Reagent, occult blood - Product Code KHE
Causa
The test strips in the affected product lots of the oc light immunological fecal occult blood test are being recalled because they may not be stable through their labeled shelf-life. there may be a possibility of obtaining false negative results when using the affected lots.
Acción
Polymedco initiated phone calls to clients on 2/12/13. When the contact was made with the client, an URGENT DEVICE RECALL letter and Fax Form were sent by e-mail/fax. Mass mailing of the URGENT DEVICE RECALL letter dated February 12, 2013 and Fax Form was done by First Class USPS on 2/14/13-2/18/13. The recall affects the test strips only. For questions, please contact Polymedco Technical Support at 1-800-431-2123 ext 285.
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.
Distribution of an unapproved device into interstate commerce.
Acción
Elana Inc. issued an Urgent: Medical Device Recall letter on February 14, 2013. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to return the Elana Catheter Sizer 2.0 as soon as possible. The Sizer 2.0 was intended as an optional accessory to the Elana Surgical Kit. The Elana Surgical Kit may be used properly without the Elana Catheter Sizer 2.0. Please acknowledge receipt of these instructions immediately by Email: Claartje@elana.com or Fax: 301-215-7038. The return shipping address for the Sizer 2.0 is Elana, Inc., 10480 Little Patuxent Parkway, Suite 400, Columbia, MD 21044 USA. Contact information for questions: Phone: 301-215-7010 or 443-538-4923 or +1 31 30 2537276 www.elana.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
Pump, infusion - Product Code FRN
Causa
A possible interruption of therapy when an e321 error code occurs while using the infuser, which is caused by battery issues.
Acción
Hospira has contracted with Stericycle Inc., in Indianapolis, IN to send letters and a reply form to Hospira customers. Receipt of the letters will be confirmed by UPS tracking. Customers will be requested to return a reply form to Stericycle indicating they have received the letter, and notified their customers. The customers will also be asked to supply the number of Plum A+ infusers at their facility.
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
Pump, infusion - Product Code FRN
Causa
A possible interruption of therapy when an e321 error code occurs while using the infuser, which is caused by battery issues.
Acción
Hospira has contracted with Stericycle Inc., in Indianapolis, IN to send letters and a reply form to Hospira customers. Receipt of the letters will be confirmed by UPS tracking. Customers will be requested to return a reply form to Stericycle indicating they have received the letter, and notified their customers. The customers will also be asked to supply the number of Plum A+ infusers at their facility.
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
Pump, infusion - Product Code FRN
Causa
A possible interruption of therapy when an e321 error code occurs while using the infuser, which is caused by battery issues.
Acción
Hospira has contracted with Stericycle Inc., in Indianapolis, IN to send letters and a reply form to Hospira customers. Receipt of the letters will be confirmed by UPS tracking. Customers will be requested to return a reply form to Stericycle indicating they have received the letter, and notified their customers. The customers will also be asked to supply the number of Plum A+ infusers at their facility.
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
Pump, infusion - Product Code FRN
Causa
A possible interruption of therapy when an e321 error code occurs while using the infuser, which is caused by battery issues.
Acción
Hospira has contracted with Stericycle Inc., in Indianapolis, IN to send letters and a reply form to Hospira customers. Receipt of the letters will be confirmed by UPS tracking. Customers will be requested to return a reply form to Stericycle indicating they have received the letter, and notified their customers. The customers will also be asked to supply the number of Plum A+ infusers at their facility.
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.
In rare instances, the bci¿ remote alarm cables (bci¿ cable) are not transferring alarms when used with some remote nurse alarm systems.
Acción
Smiths Medical sent an "Urgent Medical Device Field Safety Notice-Recall" letter dated February 96, 2013 via UPS to all affected customers. The letter described the affected product, problem and actions to be taken. Customers were instructed to inspect their inventory and remove all affected devices from use, complete and return the attached "Confirmation Form", by fax to 1-800-237-8033 or email to BCIRemote.AlarmCable@smiths-medical.com. The letter stated that a Customer representative will contact customers with instructions for returning affected products for replacement or credit. For questions contact Smiths Medical's Customer Service Department at 10-800-258-5361.
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.
It was reported from a complaint that study category labels of "prior" and "baseline" and hanging position appeared incorrectly swapped when the hanging protocol for three comparison studies is manually applied from the patient folder.
Acción
Firm sent notification letter to all impacted customer accounts. The letter provided the following instructions for customers to follow until the permanent fix for the issue was deployed: 1) The users should be instructed to look at the date on each exam displayed rather than just the labels assigned to the exam by the system. 2) If this problem is detected in your specific workflows, a system administrator can remove the study category labels (Current/Prior/Baseline)from all overlays on the images/exams. A software code change was deployed to customer sites to correct 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.
An internal protective fuse can be unintentionally activated while the device is charging its capacitors for shock delivery or induction. should this occur, the defibrillator would not be able to deliver therapy or communicate with the q-tech model 2020 programmer, and would be unable to emit tones or otherwise respond to magnet application.
Acción
Consignees were sent a Boston Scientific "Important Medical Device Information" letter dated March 1, 2012. The letter was addressed to "Dear Doctor". The letter described the product involved in the recall, the problem and provided Recommendations/Actions. US customers may contact Technical Services for more information at 800-227-3422.
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, x-ray, tomography, computed - Product Code JAK
Causa
Philips was notified of a problem using the intellispace portal with software version 4.0.2 with the url pacs integration. philips was informed that when loading a study to an analysis application while using url pacs integration configuration, after another study was opened by a review application, the analysis monitor is updated with the study of the current patient, but the review monitor conti.
Acción
Philips sent a Urgent Medical Device Correction letter dated February 12, 2013, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer.
They advised their customers that when reviewing two disparate image datasets, not to only be focused on the actual image content but to also be alerted to the patient's study name and/or ID prior to interpretation.
They recommend to manually exit the Review and Analysis applications before loading a new study to Intellispace Portal v4.0.2 from the PACS.
For North America and Canada contact the Customer Care Solutions Center at (1-800) 722-9377.
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
Reagent, occult blood - Product Code KHE
Causa
The test strips in the affected product lots of the oc light immunological fecal occult blood test are being recalled because they may not be stable through their labeled shelf-life. there may be a possibility of obtaining false negative results when using the affected lots.
Acción
Polymedco initiated phone calls to clients on 2/12/13. When the contact was made with the client, an URGENT DEVICE RECALL letter and Fax Form were sent by e-mail/fax. Mass mailing of the URGENT DEVICE RECALL letter dated February 12, 2013 and Fax Form was done by First Class USPS on 2/14/13-2/18/13. The recall affects the test strips only. For questions, please contact Polymedco Technical Support at 1-800-431-2123 ext 285.
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
Dental cement w/out zinc-oxide eugenol as an ulcer covering for pain relief - Product Code MZW
Causa
Kerr corporation is initiating this recall because raw material used to produce the maxcem elite is causing the material to prematurely polymerize in the syringe. the product could be difficult to extrude or demonstrate a shorter work-time as the material may prematurely set prior to placing restorations on the tooth or core build-up. as a result, the restoration may not be seated properly.
Acción
The firm, Kerr Corporation/Sybron Dental Specialties, sent an "URGENT: MEDICAL DEVICE RECALL" letter dated February 22, 2013 to its customers. The letter described the product, problem and actions to be taken. The customers are instructed to determine if you have any of the affected products in your inventory; If you have the affected lots, please contact Kerr Customer Care at 1-800-537-7123 to receive an RMA number for quick return; complete and return the Maxcem Elite Acknowledgement and Recall Return Form via fax to 714-288-4609 regardless of whether you have any product in your inventory. If you are an authorized Kerr Corporation distributor, identify and contact those customers that may have been shipped the affected product within 48 hours of receipt of this field correction notification.
If you have any question, contact Kerr Customer Care at 1-800-537-7123.
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
Test, time, prothrombin - Product Code GJS
Causa
Roche investigation into complaints found accu-chek inform ii and coaguchek xs pro system barcode reading meters had the potential of intermittent erroneous decoding of patient identification if barcodes being read fail to meet size and/or quality standards. errors have been confirmed with the ean 13 barcodes which should not be used for patient or operator identification.
Acción
Consignees of both devices were notified by Urgent Medical Device Correction letters sent via UPS Ground (receipt required) beginning 3/06/2013. The notice contained recommendation not to use EAN-13 barcode system and ensure barcodes used meet quality standards; use operator and patient lists (downloaded from a data manager) in order to check any decoded identification against the respective list. The notice directed forwarding of the notice if the product was further distributed. Customers were asked to complete the attached fax form. Contact the Customer Care Service Center, 24 hours a day, seven days a week at 1-800-440-3638 for Accu check questions and 1-800-428-4674 for CoaguChek questions about the information contained in this UMDC.