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
Emission Computed Tomography System - Product Code KPS
Causa
The pinion gear could crack and cause the gantry to spin freely thereby damaging the symbia s or t system and potentially injuring a patient during a scan.
Acción
Siemens sent Urgent Field Correction Recall letters dated 4/22/09 to the affected users of the Symbia S and Symbia T Systems. The accounts were informed of the potential faulty pinion gear which could crack and cause the gantry to spin freely, damaging the system and potentially injuring a patient during a scan. The customers were advised to stop using the system if they hear any abnormal grinding noise from the gantry. They also were advised that a Siemens Customer Service Representative would contact them within 60 days to schedule a replacement of the pinion gear free of charge. Any questions were directed to contact Siemens Medical Solutions USA, Inc. at 1-800-767-2313 (USA) for assistance. The accounts were requested to complete the Mandatory Fax-Back Form acknowledging receipt and understanding of the letter.
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 mantis rod inserter shaft was found to have deformation of the stainless stell split sphere when subjected to high forces, prohibiting the user from being able to grip the rod implantation and the split sphere may separate and fall into the patient.
Acción
Stryker Spine issued an "Urgent Product Recall" notification dated April 29, 2009 via Federal Express to all Consignees. Users were instructed to quarantine all affected product and fax a copy of the Product Accountability Form to 201-760-8406. A Stryker sales representative will retrieve the quarantined product.
For further information, contact Stryker Spine at 201-760-8206.
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 mantis rod inserter shaft was found to have deformation of the stainless stell split sphere when subjected to high forces, prohibiting the user from being able to grip the rod implantation and the split sphere may separate and fall into the patient.
Acción
Stryker Spine issued an "Urgent Product Recall" notification dated April 29, 2009 via Federal Express to all Consignees. Users were instructed to quarantine all affected product and fax a copy of the Product Accountability Form to 201-760-8406. A Stryker sales representative will retrieve the quarantined product.
For further information, contact Stryker Spine at 201-760-8206.
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
Emission Computed Tomography System - Product Code KPS
Causa
The pinion gear could crack and cause the gantry to spin freely thereby damaging the symbia s or t system and potentially injuring a patient during a scan.
Acción
Siemens sent Urgent Field Correction Recall letters dated 4/22/09 to the affected users of the Symbia S and Symbia T Systems. The accounts were informed of the potential faulty pinion gear which could crack and cause the gantry to spin freely, damaging the system and potentially injuring a patient during a scan. The customers were advised to stop using the system if they hear any abnormal grinding noise from the gantry. They also were advised that a Siemens Customer Service Representative would contact them within 60 days to schedule a replacement of the pinion gear free of charge. Any questions were directed to contact Siemens Medical Solutions USA, Inc. at 1-800-767-2313 (USA) for assistance. The accounts were requested to complete the Mandatory Fax-Back Form acknowledging receipt and understanding of the letter.
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.
Labeling issue: the large xia anterior staple was laser marked with an "s", indicating small.
Acción
Market Withdrawal letters were sent to Stryker branches who received product on April 13, 2007 by Federal Express. The letters asked that they examine their inventory and hospital locations to identify the implant; reconcile these implants on the attached Product Accountability Form and fax a copy to (201) 760-8456; retrieve and return the affected implants; and contact their Stryker Customer Service rep to re-order the product that they are returning as part of the regulatory action.
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
Mechanical chair - Product Code INN
Causa
The plastic buckles on the hip belts of the 4-point pelvic harness may break.
Acción
Sammons Preston, the U.S. agent for James Leckey Design Ltd., issued recall letters dated 4/17/09 to all of their customers who purchased the Leckey 4-Point Pelvic Harness, used in the Leckey Contoured Advance Seat, Leckey Early Sitting System and the Leckey Squiggles Saddle Seat, informing them that the manufacturer, James Leckey Design Ltd., is recalling the harness because the pelvic belt buckle may not lock securely and/or break. A copy of the Urgent Field Safety Notice dated 1/28/09 issued by Leckey in the United Kingdom was included with the Sammons letter. The customers were advised to be vigilant and check the hip belts daily to ensure that the user is secure in their seating system until the replacement hip belt is received. The accounts were requested to contact Carla Dreher at 1-800-288-3693, ext. 8724 for instructions on how to receive a replacement hip belt.
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
Non-Ac-Powered Patient Lift - Product Code FSA
Causa
The roll pin on certain configurations of the maxilift hanger bar could break due to a combination of severe corrosion and fatigue. breakage of the roll pin would lead to the detachment of the hanger bar from the jib of the lifter.
Acción
ArjoHuntleigh sent a Field Safety Notice DCHU-UK/0209/001FSN to all affected end users via UPS Ground on 4/27/09. The notice informed the accounts of the potential for the roll pin to break due to a combination of severe corrosion and fatigue, leading to the detachment of the hanger bar from the jib of the lift. The accounts were advised to identify if they have any Arjo Maxilift patient lifters in their facility, identify which version of Arjo Maxilift hanger bar they have using the photographs in Figures 1,2 and 3 in the letter. Any lifters found with a hanger bar attachment as shown in Figure 1 must be immediately and permanently taken out of use, as the replacement hanger bar assembly is no longer available. Any lifters with a hanger bar attachment as shown in Figure 2 must be taken out of use until a correction has been performed by ArjoHuntleigh. Any lifters with a hanger bar attachment design as shown in Figure 3 are not affected and can continue being used. The accounts were provided with a product upgrade offer and a MaxiLift Preventative Maintenance Schedule. The accounts were requested to complete and fax, e-mail or mail the enclosed Customer Response Form to Arjo at 630-925-7974 or quality@arjousa.com, indicating the number of Maxilifts in each category that they have and that the products have been taken out of service for replacement or correction, listing the model numbers and serial numbers of their lifts. Questions were directed to the ArjoHuntleigh Customer Support or Quality Department at 1-800-323-1245.
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
Venous Access Port Kits - Product Code OKE
Causa
The kits contain monoject prefill heparin lock flush syringes, which were recalled by the manufacturer due to contamination.
Acción
Tri State Hospital notified their consignees by letter dated 4/8/08 and instructed to discontinue use of the product and to either discard or return it.
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
Central Venous Catheter - Product Code OFF
Causa
The kits contain monoject prefill heparin lock flush syringes, which were recalled by the manufacturer due to contamination.
Acción
Tri State Hospital notified their consignees by letter dated 4/8/08 and instructed to discontinue use of the product and to either discard or return it.
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
Port Access Tray - Product Code OKE
Causa
The kits contain monoject prefill heparin lock flush syringes, which were recalled by the manufacturer due to contamination.
Acción
Tri State Hospital notified their consignees by letter dated 4/8/08 and instructed to discontinue use of the product and to either discard or return it.
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
Port Blood Draw Tray - Product Code OKE
Causa
The kits contain monoject prefill heparin lock flush syringes, which were recalled by the manufacturer due to contamination.
Acción
Tri State Hospital notified their consignees by letter dated 4/8/08 and instructed to discontinue use of the product and to either discard or return it.
Finnish data is current through April 2018. All of the data comes from Valvira - National Supervisory Authority for Welfare and Health, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Finland.
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 MNH
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
Pedicle screw spinal system - Product Code MNH
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
Pedicle screw spinal system - Product Code MNH
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
Pedicle screw spinal system - Product Code MNI
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
Ventricular Support System - Product Code DSQ
Causa
Ipulse console sc1035 displayed a "low pressure / low flow" alarm and stopped pumping during patient transport in battery operation.
Acción
An "Urgent Voluntary Medical Device Field Correction Notice" was issued April 8, 2009 to affected customers. The customers were notified that the iPulse Console SC1032 displayed a "Low Pressure/ Low Flow" alarm and stopped pumping during patient transport in battery operation. Instructions were provided to users in case they encounter this failure mode. ABIOMED Field Service Engineers will contact customers to schedule a time to visit site and correct affected consoles. Please contact ABIOMED's Field Service at 1.800.554.8666, if you have any questions.
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.
Laborie medical technologies reports that there was a mix up in the labeling and packaging of their urodynamic catheters. there were 8fr catheters mixed inside the 6fr catheter packages.
Acción
Laborie Medical Technologies notified customers by telephone/email beginning April 10, 2009 advising them of the mislabelled product.
For further questions, contact Laborie Medical Technologies at 1-800-522-6743.
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 cup associated with these lots of product may have a pin-sized hole in the floor of the cup. as a result, there is a potential for affected lots of cups to leak urine after an extended period of time.
Acción
Biosite, Inc. issued a "Notice of Correction" letter dated May 1, 2009 to consignees describing the problem and instructed users of proper use in order to avoid any cross contamination of samples until all affected product is completely used.
For further information, contact Biosite, Inc. using the following information:
Biosite Incorporated, an Inverness Medical Company
9975 Summers Ridge Road
San Diego, CA 92121
Phone: 1-877-441-7440, option 2
Fax: 1-858-695-7100
Email: productadvisory@invmed.com
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
The cup associated with these lots of product may have a pin-sized hole in the floor of the cup. as a result, there is a potential for affected lots of cups to leak urine after an extended period of time.
Acción
Biosite, Inc. issued a "Notice of Correction" letter dated May 1, 2009 to consignees describing the problem and instructed users of proper use in order to avoid any cross contamination of samples until all affected product is completely used.
For further information, contact Biosite, Inc. using the following information:
Biosite Incorporated, an Inverness Medical Company
9975 Summers Ridge Road
San Diego, CA 92121
Phone: 1-877-441-7440, option 2
Fax: 1-858-695-7100
Email: productadvisory@invmed.com
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
The cup associated with these lots of product may have a pin-sized hole in the floor of the cup. as a result, there is a potential for affected lots of cups to leak urine after an extended period of time.
Acción
Biosite, Inc. issued a "Notice of Correction" letter dated May 1, 2009 to consignees describing the problem and instructed users of proper use in order to avoid any cross contamination of samples until all affected product is completely used.
For further information, contact Biosite, Inc. using the following information:
Biosite Incorporated, an Inverness Medical Company
9975 Summers Ridge Road
San Diego, CA 92121
Phone: 1-877-441-7440, option 2
Fax: 1-858-695-7100
Email: productadvisory@invmed.com
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
The cup associated with these lots of product may have a pin-sized hole in the floor of the cup. as a result, there is a potential for affected lots of cups to leak urine after an extended period of time.
Acción
Biosite, Inc. issued a "Notice of Correction" letter dated May 1, 2009 to consignees describing the problem and instructed users of proper use in order to avoid any cross contamination of samples until all affected product is completely used.
For further information, contact Biosite, Inc. using the following information:
Biosite Incorporated, an Inverness Medical Company
9975 Summers Ridge Road
San Diego, CA 92121
Phone: 1-877-441-7440, option 2
Fax: 1-858-695-7100
Email: productadvisory@invmed.com
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
The cup associated with these lots of product may have a pin-sized hole in the floor of the cup. as a result, there is a potential for affected lots of cups to leak urine after an extended period of time.
Acción
Biosite, Inc. issued a "Notice of Correction" letter dated May 1, 2009 to consignees describing the problem and instructed users of proper use in order to avoid any cross contamination of samples until all affected product is completely used.
For further information, contact Biosite, Inc. using the following information:
Biosite Incorporated, an Inverness Medical Company
9975 Summers Ridge Road
San Diego, CA 92121
Phone: 1-877-441-7440, option 2
Fax: 1-858-695-7100
Email: productadvisory@invmed.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
circulatory assist device - Product Code DRN
Causa
Cuff may underinflate, or device may stop working during use. cardioassist software version 4.3.1 utilized a signal from the plethysmograph that was found not to be sensitive enough due to the shape of the waveform in certain circumstances where there was excessive motion artifact.
Acción
Service visit to customer in May 2009 to upgrade and validate CardioAssist 4000 software to version 4.3.5.