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
Bone fixation appliances - Product Code HSB
Causa
Some devices could have been made with raw material lots that may have inclusions, and could result in decreased strength of the device.
Acción
The firm sent Urgent Recall Notices to all direct accounts, hospital Risk Management and Physicians by first class mail.
Letters are dated March 29, 2009, April 2, 2009 and April 16, 2009 respectively. The letter describes the problem and that that there is a possible risk of a device failure.
An additional e-mail was sent on May 22, 2009 to 5 customers due to an expansion of the recall to include 4 additional items.
On June 19, 2009, the firm again expanded the recall to include 2 additional products and notified customers.
Questions should be directed to William Hennig, at 1.973.299.9300. ext. 1557.
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
Bone fixation appliances - Product Code HSB
Causa
Some devices could have been made with raw material lots that may have inclusions, and could result in decreased strength of the device.
Acción
The firm sent Urgent Recall Notices to all direct accounts, hospital Risk Management and Physicians by first class mail.
Letters are dated March 29, 2009, April 2, 2009 and April 16, 2009 respectively. The letter describes the problem and that that there is a possible risk of a device failure.
An additional e-mail was sent on May 22, 2009 to 5 customers due to an expansion of the recall to include 4 additional items.
On June 19, 2009, the firm again expanded the recall to include 2 additional products and notified customers.
Questions should be directed to William Hennig, at 1.973.299.9300. ext. 1557.
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
Bone fixation appliances - Product Code HSB
Causa
Some devices could have been made with raw material lots that may have inclusions, and could result in decreased strength of the device.
Acción
The firm sent Urgent Recall Notices to all direct accounts, hospital Risk Management and Physicians by first class mail.
Letters are dated March 29, 2009, April 2, 2009 and April 16, 2009 respectively. The letter describes the problem and that that there is a possible risk of a device failure.
An additional e-mail was sent on May 22, 2009 to 5 customers due to an expansion of the recall to include 4 additional items.
On June 19, 2009, the firm again expanded the recall to include 2 additional products and notified customers.
Questions should be directed to William Hennig, at 1.973.299.9300. ext. 1557.
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
Bone fixation appliances - Product Code HSB
Causa
Some devices could have been made with raw material lots that may have inclusions, and could result in decreased strength of the device.
Acción
The firm sent Urgent Recall Notices to all direct accounts, hospital Risk Management and Physicians by first class mail.
Letters are dated March 29, 2009, April 2, 2009 and April 16, 2009 respectively. The letter describes the problem and that that there is a possible risk of a device failure.
An additional e-mail was sent on May 22, 2009 to 5 customers due to an expansion of the recall to include 4 additional items.
On June 19, 2009, the firm again expanded the recall to include 2 additional products and notified customers.
Questions should be directed to William Hennig, at 1.973.299.9300. ext. 1557.
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
Bone fixation appliances - Product Code HSB
Causa
Some devices could have been made with raw material lots that may have inclusions, and could result in decreased strength of the device.
Acción
The firm sent Urgent Recall Notices to all direct accounts, hospital Risk Management and Physicians by first class mail.
Letters are dated March 29, 2009, April 2, 2009 and April 16, 2009 respectively. The letter describes the problem and that that there is a possible risk of a device failure.
An additional e-mail was sent on May 22, 2009 to 5 customers due to an expansion of the recall to include 4 additional items.
On June 19, 2009, the firm again expanded the recall to include 2 additional products and notified customers.
Questions should be directed to William Hennig, at 1.973.299.9300. ext. 1557.
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
Pressure Infusor Bag - Product Code KZD
Causa
Potential sterility breach caused by excessive shipment damage.
Acción
Merit Medical Customers were contacted directly by phone and letter on 9/29/09. Customers were instructed to identify and quarantine all unused affected product. Further information was available at 801-208-4365.
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
Pedicle screw spinal system - Product Code HSB
Causa
Some devices could have been made with raw material lots that may have inclusions, and could result in decreased strength of the device.
Acción
The firm sent Urgent Recall Notices to all direct accounts, hospital Risk Management and Physicians by first class mail.
Letters are dated March 29, 2009, April 2, 2009 and April 16, 2009 respectively. The letter describes the problem and that that there is a possible risk of a device failure.
An additional e-mail was sent on May 22, 2009 to 5 customers due to an expansion of the recall to include 4 additional items.
On June 19, 2009, the firm again expanded the recall to include 2 additional products and notified customers.
Questions should be directed to William Hennig, at 1.973.299.9300. ext. 1557.
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
Rod, Fixation, Intramedullary And Accessories - Product Code HSB
Causa
Some devices could have been made with raw material lots that may have inclusions, and could result in decreased strength of the device.
Acción
The firm sent Urgent Recall Notices to all direct accounts, hospital Risk Management and Physicians by first class mail.
Letters are dated March 29, 2009, April 2, 2009 and April 16, 2009 respectively. The letter describes the problem and that that there is a possible risk of a device failure.
An additional e-mail was sent on May 22, 2009 to 5 customers due to an expansion of the recall to include 4 additional items.
On June 19, 2009, the firm again expanded the recall to include 2 additional products and notified customers.
Questions should be directed to William Hennig, at 1.973.299.9300. ext. 1557.
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
Intramedullary fixation rod - Product Code HSB
Causa
Some devices could have been made with raw material lots that may have inclusions, and could result in decreased strength of the device.
Acción
The firm sent Urgent Recall Notices to all direct accounts, hospital Risk Management and Physicians by first class mail.
Letters are dated March 29, 2009, April 2, 2009 and April 16, 2009 respectively. The letter describes the problem and that that there is a possible risk of a device failure.
An additional e-mail was sent on May 22, 2009 to 5 customers due to an expansion of the recall to include 4 additional items.
On June 19, 2009, the firm again expanded the recall to include 2 additional products and notified customers.
Questions should be directed to William Hennig, at 1.973.299.9300. ext. 1557.
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
Intramedullary fixation rod - Product Code HSB
Causa
Some devices could have been made with raw material lots that may have inclusions, and could result in decreased strength of the device.
Acción
The firm sent Urgent Recall Notices to all direct accounts, hospital Risk Management and Physicians by first class mail.
Letters are dated March 29, 2009, April 2, 2009 and April 16, 2009 respectively. The letter describes the problem and that that there is a possible risk of a device failure.
An additional e-mail was sent on May 22, 2009 to 5 customers due to an expansion of the recall to include 4 additional items.
On June 19, 2009, the firm again expanded the recall to include 2 additional products and notified customers.
Questions should be directed to William Hennig, at 1.973.299.9300. ext. 1557.
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
Intramedullary fixation rod - Product Code HSB
Causa
Some devices could have been made with raw material lots that may have inclusions, and could result in decreased strength of the device.
Acción
The firm sent Urgent Recall Notices to all direct accounts, hospital Risk Management and Physicians by first class mail.
Letters are dated March 29, 2009, April 2, 2009 and April 16, 2009 respectively. The letter describes the problem and that that there is a possible risk of a device failure.
An additional e-mail was sent on May 22, 2009 to 5 customers due to an expansion of the recall to include 4 additional items.
On June 19, 2009, the firm again expanded the recall to include 2 additional products and notified customers.
Questions should be directed to William Hennig, at 1.973.299.9300. ext. 1557.
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
Pressure Infusor Bag - Product Code MDM
Causa
Potential sterility breach caused by excessive shipment damage.
Acción
Merit Medical Customers were contacted directly by phone and letter on 9/29/09. Customers were instructed to identify and quarantine all unused affected product. Further information was available at 801-208-4365.
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
Intramedullary fixation rod - Product Code HSB
Causa
Some devices could have been made with raw material lots that may have inclusions, and could result in decreased strength of the device.
Acción
The firm sent Urgent Recall Notices to all direct accounts, hospital Risk Management and Physicians by first class mail.
Letters are dated March 29, 2009, April 2, 2009 and April 16, 2009 respectively. The letter describes the problem and that that there is a possible risk of a device failure.
An additional e-mail was sent on May 22, 2009 to 5 customers due to an expansion of the recall to include 4 additional items.
On June 19, 2009, the firm again expanded the recall to include 2 additional products and notified customers.
Questions should be directed to William Hennig, at 1.973.299.9300. ext. 1557.
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
insulin syringe - Product Code FMF
Causa
Needles separate from the barrel of the syringes.
Acción
On 04/09/2009, Qualitest issued a press release and sent out recall notifications to their consignees by US Mail. The recall was extended to the User level. Qualitest will send a second letter to all non-responders after thirty days. Thirty days after the second letter, Qualitest will perform a recall effectiveness check by telephone on a percentage of non-responders (in accordance with FDA request).
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
Bone Fixation Plate - Product Code HRS
Causa
Sterility may be compromised due to a ineffective package design.
Acción
All affected Synthes DMF Sales Consultants were notified of the Medical Device Recall by an Urgent: Medical Device Recall letter notification which was sent via USPS certified mail on 4/6/09. The letter stated the problem and risk. The firm recommended that patients who have had a surgical procedure in which these products were utilized be monitored for signs/symptoms of infection for a period of six months following surgery. If customers have any of the identified devices, they are to call Synthes at 1-800-479-6329 to obtain a Return Authorization Number; complete the form; and return the letter with the recalled product to the address provided. Customers that do not have the identified product, are to complete the attached form and return the document to the address provided acknowledging their receipt of the recall information. Questions should be directed to their Synthes CMF Sales Consultant.
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
Bone Fixation Plate - Product Code HRS
Causa
Sterility may be compromised due to a ineffective package design.
Acción
All affected Synthes DMF Sales Consultants were notified of the Medical Device Recall by an Urgent: Medical Device Recall letter notification which was sent via USPS certified mail on 4/6/09. The letter stated the problem and risk. The firm recommended that patients who have had a surgical procedure in which these products were utilized be monitored for signs/symptoms of infection for a period of six months following surgery. If customers have any of the identified devices, they are to call Synthes at 1-800-479-6329 to obtain a Return Authorization Number; complete the form; and return the letter with the recalled product to the address provided. Customers that do not have the identified product, are to complete the attached form and return the document to the address provided acknowledging their receipt of the recall information. Questions should be directed to their Synthes CMF Sales Consultant.
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.
Software anomaly: software anomaly can occur when the panorama is attempting to play an audio file, either a physiological or technical alarm sound, at which time the system software may cause the system to freeze due to an interaction in the alarm system.
Acción
Urgent Product Field Correction letters, dated March 27, 2009, were sent by certified mail, return requested, and signature required. The letters identified the affected product and the problem. It also stated the adverse effect on patients and that customers' Panorama software will be upgraded to a current software revision. A Datascope Service Representative will contact customers to arrange for the software upgrade of the Panorama(s) in their facility. This will be done at no cost to the customer.
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
Template - Product Code HWT
Causa
The trial stems were manufactured using the wrong design.
Acción
The firm notified their consignees of their product recall by parcel post on 07/16/2013.
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
Femoral Hip Prosthesis - Product Code LZO
Causa
Packaging burst test values for the restoration modular cone body family were found to be incorrectly transferred from the finalized validation to the work specification. testing showed that burst test results for recalled products fell below the validated parameters.
Acción
Urgent Product Recall letters were sent via Federal Express on April 2, 2009 to Stryker branches, Chief of Orthopaedics, Hospital Rick Management and Surgeons. The letter stated the issue, the potential hazards, and the risk mitigation. Customers were asked to examine their inventory and hospital locations to identify the affected products; retrieve all effected products and return it to their branch or agency warehouse for reconciliation; reconcile all products on the attached Product Accountability Form and fax a copy to the number listed; return the affected product via the Inter-Org Transfer and ship it to the attention of the individual listed; attach the fluorescent orange PRODUCT REMEDIATION sticker to their return, indicating the Product Remediation #, and mark the box with the words "PRODUCT RECALL". Questions should be directed to Colleen O'Meara at 201-831-5970.
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
strep test in vitro diagnostic - Product Code GTZ
Causa
Potential for false positive strep a results.
Acción
Inverness Medical notified Customers by letter sent via Fedex April 6, 2009 . The letter included a request for a response from the customer. The product is discontinued.
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
Glucose Test System - Product Code CGA
Causa
It appears that the rechargeable battery pack is overheating with or without the presence of smoke.
Acción
Urgent Recall Notice letters dated April 2009 were sent out the third week of April by Federal Express. The letter discussed the background, required actions, and additional information. Customers are to identify all affected Martel printer rechargeable battery packs, record the number of affected packs on the attached business reply cards, and return the card along with the affected batteries as instructed. Questions should be directed to Abbott Technical Support at 800-366-8020.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notas adicionales en la data
patient information systems - Product Code NSX
Causa
Demographic data, most notably allergy and precaution data, can be overwritten with incomplete data or blanks by the interface between non-picis clinical systems (your "his" or "cis") and certain picis applications, if that interface is not configured properly.
Acción
On April 8th 2009, Picis initiated a customer notification letter to the installed base of potentially affected users, explaining the potential source of patient data conflict and to provide support in choosing the appropriate configuration option and implementation. The notification letters included with this report package contain additional details regarding configuration options.
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 Introducer - Product Code DYB
Causa
External tubing may separate during use, allowing blood loss.
Acción
All of Merit's US sales representatives and distributors were notified by Prelude Short Sheath Introducer - Product Recall letter on 4/14/2009. They were instructed to promptly contact their customers. Customers were instructed to isolate, remove from inventory, and return all affected inventory. A Product Retrieval Form was to be returned to Merit. Further information is available at 801-316-4998 or 801-208-4344.
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 Introducer - Product Code DYB
Causa
External tubing may separate during use, allowing blood loss.
Acción
All of Merit's US sales representatives and distributors were notified by Prelude Short Sheath Introducer - Product Recall letter on 4/14/2009. They were instructed to promptly contact their customers. Customers were instructed to isolate, remove from inventory, and return all affected inventory. A Product Retrieval Form was to be returned to Merit. Further information is available at 801-316-4998 or 801-208-4344.
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 Introducer - Product Code DYB
Causa
External tubing may separate during use, allowing blood loss.
Acción
All of Merit's US sales representatives and distributors were notified by Prelude Short Sheath Introducer - Product Recall letter on 4/14/2009. They were instructed to promptly contact their customers. Customers were instructed to isolate, remove from inventory, and return all affected inventory. A Product Retrieval Form was to be returned to Merit. Further information is available at 801-316-4998 or 801-208-4344.