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
blankets and warming accessories - Product Code FME
Causa
The products are not compatible for use in the magnetic resonance imaging (mri) environment.
Acción
A press release distributed through specialized news media, and trade magazines, on/about 12/26/2009. The press release was also posted on the thermoflect.com website. Letters were sent via first class mail to customers, hospitals and doctors in radiology on/about 12/23/2009. In addition to the written notification to the user institutions, Encompass provided adhesive labels sent along with the letter notification. The notice instructed that the labels should be affixed to remaining inventories of the products(s), specifically to the individual package, which holds 5 blankets and to the outermost packaging or carton. The label reads Not for use in MRI, and a symbol showing a circle with a diagonal line through the letters MR. Thermoflect product literature has been quarantine at this time. Instructions were provided showing where the labels where the labels were to be affixed. Encompass also provided a poster indicating the products are for use in the MR environment which is to be displayed in the MR area. All new product literature will indicate that the product is not for ruse in the MR environment. Thermoflect sales representatives will visit with each user institution to confirm their receipt of the recall notice and to be available to answer any question concerning the recall. The sales representatives all of whom have been briefed on the recall strategy will be available to provide training for Radiation Safety Officers and radiology staff, if requested. Following the recall notice, Encompass will conduct Effectiveness Checks to assure that all purchasers/users of the Thermoflect product have been notified and have taken appropriate action to notify their radiology centers and staff. The Encompass recall team will maintain records of the contacts for review by the FDA. A Status Report on the effectiveness of the recall effort will be filed with the Atlanta District Office on a monthly basis until the recall is terminated.
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.
Product name change requires conversion to a different type of pma and implies that the product could be used to assess whether a patient's pregnancy is full term, or to predict imminent delivery in women who are at full term gestation.
Acción
The firm, Hologic, sent a "Important-Product Recall/Correction" letter dated December 18, 2009 to its customers. The letter described the product, problem and the actions to be taken. The customers were instructed to 1) replace the directional inserts for the specimen collection kit and health care providers' brochure with provided instructions, 2) over-label specimen collection kit boxes with provided stickers and individual kits, 3) permanently destroy any marketing and educational materials with the "full term" name and 4) complete and return the CUSTOMER RECALL RESPONSE FORM via fax at 408-744-1905 or scan and email to recallfullterm@hologic.com.
If you have any questions about this notification, please contact the Hotline (800-442-9892, Option 7# or 508-263-8510).
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.
Triathlon ts femoral components may have been damaged during manufacturing, possibly preventing the assembly of a stem extension.
Acción
An "Urgent Product Recall" Letter dated December 10, 2009 was sent by Federal Express to all Stryker Branches, Chief of Orthopaedics, Hospital Risk Management and Surgeons. The letter described the affected product, issue and potential hazards. Consignees were instructed to complete Product Recall Acknowledgement Form and return to Stryker Orthopaedics via fax at 1-201-831-6069.
All questions regarding the recall should be directed to Stryker Orthopaedics at 1-201-972-2100.
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
Gynocological catheter - Product Code MOV
Causa
The distal tip may separate from the catheter while the catheter is in the patient.
Acción
Cook Women's Health sent Urgent Recall Notice letters dated 1/8/2010. Consignees were instructed to return product to the manufacturer for credit.
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.
Triathlon ts femoral components may have been damaged during manufacturing, possibly preventing the assembly of a stem extension.
Acción
An "Urgent Product Recall" Letter dated December 10, 2009 was sent by Federal Express to all Stryker Branches, Chief of Orthopaedics, Hospital Risk Management and Surgeons. The letter described the affected product, issue and potential hazards. Consignees were instructed to complete Product Recall Acknowledgement Form and return to Stryker Orthopaedics via fax at 1-201-831-6069.
All questions regarding the recall should be directed to Stryker Orthopaedics at 1-201-972-2100.
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.
Triathlon ts femoral components may have been damaged during manufacturing, possibly preventing the assembly of a stem extension.
Acción
An "Urgent Product Recall" Letter dated December 10, 2009 was sent by Federal Express to all Stryker Branches, Chief of Orthopaedics, Hospital Risk Management and Surgeons. The letter described the affected product, issue and potential hazards. Consignees were instructed to complete Product Recall Acknowledgement Form and return to Stryker Orthopaedics via fax at 1-201-831-6069.
All questions regarding the recall should be directed to Stryker Orthopaedics at 1-201-972-2100.
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.
Triathlon ts femoral components may have been damaged during manufacturing, possibly preventing the assembly of a stem extension.
Acción
An "Urgent Product Recall" Letter dated December 10, 2009 was sent by Federal Express to all Stryker Branches, Chief of Orthopaedics, Hospital Risk Management and Surgeons. The letter described the affected product, issue and potential hazards. Consignees were instructed to complete Product Recall Acknowledgement Form and return to Stryker Orthopaedics via fax at 1-201-831-6069.
All questions regarding the recall should be directed to Stryker Orthopaedics at 1-201-972-2100.
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.
Triathlon ts femoral components may have been damaged during manufacturing, possibly preventing the assembly of a stem extension.
Acción
An "Urgent Product Recall" Letter dated December 10, 2009 was sent by Federal Express to all Stryker Branches, Chief of Orthopaedics, Hospital Risk Management and Surgeons. The letter described the affected product, issue and potential hazards. Consignees were instructed to complete Product Recall Acknowledgement Form and return to Stryker Orthopaedics via fax at 1-201-831-6069.
All questions regarding the recall should be directed to Stryker Orthopaedics at 1-201-972-2100.
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.
Product name change requires conversion to a different type of pma and implies that the product could be used to assess whether a patient's pregnancy is full term, or to predict imminent delivery in women who are at full term gestation.
Acción
The firm, Hologic, sent a "Important-Product Recall/Correction" letter dated December 18, 2009 to its customers. The letter described the product, problem and the actions to be taken. The customers were instructed to 1) replace the directional inserts for the specimen collection kit and health care providers' brochure with provided instructions, 2) over-label specimen collection kit boxes with provided stickers and individual kits, 3) permanently destroy any marketing and educational materials with the "full term" name and 4) complete and return the CUSTOMER RECALL RESPONSE FORM via fax at 408-744-1905 or scan and email to recallfullterm@hologic.com.
If you have any questions about this notification, please contact the Hotline (800-442-9892, Option 7# or 508-263-8510).
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
Hip Stems - Product Code LWJ
Causa
Sterility (package integrity) compromised: device package damaged during shipment.
Acción
The recalling firm issued an Important Recall Notice letter dated 10/10/07 to all their customers informing them of the problem and the need to return the product.
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.
Product name change requires conversion to a different type of pma and implies that the product could be used to assess whether a patient's pregnancy is full term, or to predict imminent delivery in women who are at full term gestation.
Acción
The firm, Hologic, sent a "Important-Product Recall/Correction" letter dated December 18, 2009 to its customers. The letter described the product, problem and the actions to be taken. The customers were instructed to 1) replace the directional inserts for the specimen collection kit and health care providers' brochure with provided instructions, 2) over-label specimen collection kit boxes with provided stickers and individual kits, 3) permanently destroy any marketing and educational materials with the "full term" name and 4) complete and return the CUSTOMER RECALL RESPONSE FORM via fax at 408-744-1905 or scan and email to recallfullterm@hologic.com.
If you have any questions about this notification, please contact the Hotline (800-442-9892, Option 7# or 508-263-8510).
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel data.
Product name change requires conversion to a different type of pma and implies that the product could be used to assess whether a patient's pregnancy is full term, or to predict imminent delivery in women who are at full term gestation.
Acción
The firm, Hologic, sent a "Important-Product Recall/Correction" letter dated December 18, 2009 to its customers. The letter described the product, problem and the actions to be taken. The customers were instructed to 1) replace the directional inserts for the specimen collection kit and health care providers' brochure with provided instructions, 2) over-label specimen collection kit boxes with provided stickers and individual kits, 3) permanently destroy any marketing and educational materials with the "full term" name and 4) complete and return the CUSTOMER RECALL RESPONSE FORM via fax at 408-744-1905 or scan and email to recallfullterm@hologic.com.
If you have any questions about this notification, please contact the Hotline (800-442-9892, Option 7# or 508-263-8510).
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.
Product name change requires conversion to a different type of pma and implies that the product could be used to assess whether a patient's pregnancy is full term, or to predict imminent delivery in women who are at full term gestation.
Acción
The firm, Hologic, sent a "Important-Product Recall/Correction" letter dated December 18, 2009 to its customers. The letter described the product, problem and the actions to be taken. The customers were instructed to 1) replace the directional inserts for the specimen collection kit and health care providers' brochure with provided instructions, 2) over-label specimen collection kit boxes with provided stickers and individual kits, 3) permanently destroy any marketing and educational materials with the "full term" name and 4) complete and return the CUSTOMER RECALL RESPONSE FORM via fax at 408-744-1905 or scan and email to recallfullterm@hologic.com.
If you have any questions about this notification, please contact the Hotline (800-442-9892, Option 7# or 508-263-8510).
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.
Product name change requires conversion to a different type of pma and implies that the product could be used to assess whether a patient's pregnancy is full term, or to predict imminent delivery in women who are at full term gestation.
Acción
The firm, Hologic, sent a "Important-Product Recall/Correction" letter dated December 18, 2009 to its customers. The letter described the product, problem and the actions to be taken. The customers were instructed to 1) replace the directional inserts for the specimen collection kit and health care providers' brochure with provided instructions, 2) over-label specimen collection kit boxes with provided stickers and individual kits, 3) permanently destroy any marketing and educational materials with the "full term" name and 4) complete and return the CUSTOMER RECALL RESPONSE FORM via fax at 408-744-1905 or scan and email to recallfullterm@hologic.com.
If you have any questions about this notification, please contact the Hotline (800-442-9892, Option 7# or 508-263-8510).
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.
NERL Diagnostics notified distributors on January 15, 2010, by letter to advise of the recall and request they examine inventory, discontinue use of affected lot numbers and discard any remaining inventory. In addition, if product was further distributed, notify the customers of the product recall.
If you have any questions, please telephone 1-401-824-2046.
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 Mulch Screw - Product Code HWC
Causa
The screw may not have the hex dimension inside of the head of the screw, which will prevent the device from being implantable. this may cause a delay in the procedure while another screw is obtained.
Acción
Hospitals, distributors, and other customers were notified by letter dated 12/22/09 and instructed to locate and return these lots of product. Questions related to this notice should be directed to the firm at 800-348-9500 or 574-372-3983, Monday through Friday, 8AM to 5PM.
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 KWQ
Causa
The devices may fracture, resulting in surgical delay or the need for intervention to remove fragments from the surgical site.
Acción
The affected instruments were removed and replaced in the U.S. Abbott Spine and Spinal Concepts instrument kits between December 2005 and October 2007. User accounts were not advised of the removal Zimmer has confirmed that none of these instruments are currently available for use in the U.S.
For further information about this action, contact Dale Miller of Zimmer at 574 372-4962.
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 KWQ
Causa
The devices may fracture, resulting in surgical delay or the need for intervention to remove fragments from the surgical site.
Acción
The affected instruments were removed and replaced in the U.S. Abbott Spine and Spinal Concepts instrument kits between December 2005 and October 2007. User accounts were not advised of the removal Zimmer has confirmed that none of these instruments are currently available for use in the U.S.
For further information about this action, contact Dale Miller of Zimmer at 574 372-4962.
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 KWQ
Causa
The devices may fracture, resulting in surgical delay or the need for intervention to remove fragments from the surgical site.
Acción
The affected instruments were removed and replaced in the U.S. Abbott Spine and Spinal Concepts instrument kits between December 2005 and October 2007. User accounts were not advised of the removal Zimmer has confirmed that none of these instruments are currently available for use in the U.S.
For further information about this action, contact Dale Miller of Zimmer at 574 372-4962.
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 KWQ
Causa
The devices may fracture, resulting in surgical delay or the need for intervention to remove fragments from the surgical site.
Acción
The affected instruments were removed and replaced in the U.S. Abbott Spine and Spinal Concepts instrument kits between December 2005 and October 2007. User accounts were not advised of the removal Zimmer has confirmed that none of these instruments are currently available for use in the U.S.
For further information about this action, contact Dale Miller of Zimmer at 574 372-4962.
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.
ICU Medical, Inc. acquired from Pfizer in early 2017, Hospira Infusion Systems, the portion of Hospira dedicated to develop infusion pumps.
Notas adicionales en la data
Intravascular Administration Set - Product Code FPA
Causa
Reports of difficulty in adjusting the flow rate, which could result in flow rate variances.
Acción
Hospira sent the Urgent Device Recall letters dated 11/25/09 to their direct accounts of the affected products and requested these consignees to notify their customers of the recall. The accounts were informed that Hospira ceased manufacturing the I.V. gravity and pump administration sets with the CAIR clamp manufactured by Borla S.P.A. of Italy in March 2008, due to customer reports related to a difference in the zone of control used to adjust the flow compared to the original CAIR clamp design. To avoid the possibility of flow rate variances, Hospira is recalling all remaining sets with the Borla designed CAIR clamp. The accounts were requested to quarantine all inventory of the affected lots, complete the enclosed reply form indicating the amount of product being returned, fax a copy of the completed form to Stericycle at 1-877-377-5114, and include a copy with the returned goods to Stericycle at 2670 Executive Drive, Suite A, Indianapolis, IN 46241.
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.
ICU Medical, Inc. acquired from Pfizer in early 2017, Hospira Infusion Systems, the portion of Hospira dedicated to develop infusion pumps.
Notas adicionales en la data
Intravascular Administration Set - Product Code FPA
Causa
Reports of difficulty in adjusting the flow rate, which could result in flow rate variances.
Acción
Hospira sent the Urgent Device Recall letters dated 11/25/09 to their direct accounts of the affected products and requested these consignees to notify their customers of the recall. The accounts were informed that Hospira ceased manufacturing the I.V. gravity and pump administration sets with the CAIR clamp manufactured by Borla S.P.A. of Italy in March 2008, due to customer reports related to a difference in the zone of control used to adjust the flow compared to the original CAIR clamp design. To avoid the possibility of flow rate variances, Hospira is recalling all remaining sets with the Borla designed CAIR clamp. The accounts were requested to quarantine all inventory of the affected lots, complete the enclosed reply form indicating the amount of product being returned, fax a copy of the completed form to Stericycle at 1-877-377-5114, and include a copy with the returned goods to Stericycle at 2670 Executive Drive, Suite A, Indianapolis, IN 46241.
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.
ICU Medical, Inc. acquired from Pfizer in early 2017, Hospira Infusion Systems, the portion of Hospira dedicated to develop infusion pumps.
Notas adicionales en la data
Intravascular Administration Set - Product Code FPA
Causa
Reports of difficulty in adjusting the flow rate, which could result in flow rate variances.
Acción
Hospira sent the Urgent Device Recall letters dated 11/25/09 to their direct accounts of the affected products and requested these consignees to notify their customers of the recall. The accounts were informed that Hospira ceased manufacturing the I.V. gravity and pump administration sets with the CAIR clamp manufactured by Borla S.P.A. of Italy in March 2008, due to customer reports related to a difference in the zone of control used to adjust the flow compared to the original CAIR clamp design. To avoid the possibility of flow rate variances, Hospira is recalling all remaining sets with the Borla designed CAIR clamp. The accounts were requested to quarantine all inventory of the affected lots, complete the enclosed reply form indicating the amount of product being returned, fax a copy of the completed form to Stericycle at 1-877-377-5114, and include a copy with the returned goods to Stericycle at 2670 Executive Drive, Suite A, Indianapolis, IN 46241.
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.
ICU Medical, Inc. acquired from Pfizer in early 2017, Hospira Infusion Systems, the portion of Hospira dedicated to develop infusion pumps.
Notas adicionales en la data
Intravascular Administration Set - Product Code FPA
Causa
Reports of difficulty in adjusting the flow rate, which could result in flow rate variances.
Acción
Hospira sent the Urgent Device Recall letters dated 11/25/09 to their direct accounts of the affected products and requested these consignees to notify their customers of the recall. The accounts were informed that Hospira ceased manufacturing the I.V. gravity and pump administration sets with the CAIR clamp manufactured by Borla S.P.A. of Italy in March 2008, due to customer reports related to a difference in the zone of control used to adjust the flow compared to the original CAIR clamp design. To avoid the possibility of flow rate variances, Hospira is recalling all remaining sets with the Borla designed CAIR clamp. The accounts were requested to quarantine all inventory of the affected lots, complete the enclosed reply form indicating the amount of product being returned, fax a copy of the completed form to Stericycle at 1-877-377-5114, and include a copy with the returned goods to Stericycle at 2670 Executive Drive, Suite A, Indianapolis, IN 46241.
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.
ICU Medical, Inc. acquired from Pfizer in early 2017, Hospira Infusion Systems, the portion of Hospira dedicated to develop infusion pumps.
Notas adicionales en la data
Intravascular Administration Set - Product Code FPA
Causa
Reports of difficulty in adjusting the flow rate, which could result in flow rate variances.
Acción
Hospira sent the Urgent Device Recall letters dated 11/25/09 to their direct accounts of the affected products and requested these consignees to notify their customers of the recall. The accounts were informed that Hospira ceased manufacturing the I.V. gravity and pump administration sets with the CAIR clamp manufactured by Borla S.P.A. of Italy in March 2008, due to customer reports related to a difference in the zone of control used to adjust the flow compared to the original CAIR clamp design. To avoid the possibility of flow rate variances, Hospira is recalling all remaining sets with the Borla designed CAIR clamp. The accounts were requested to quarantine all inventory of the affected lots, complete the enclosed reply form indicating the amount of product being returned, fax a copy of the completed form to Stericycle at 1-877-377-5114, and include a copy with the returned goods to Stericycle at 2670 Executive Drive, Suite A, Indianapolis, IN 46241.