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
Arthroscope - Product Code HRX
Causa
This recall was due to the possibility that multiple products may have a breach in the poly-tyvek pouch that could potentially compromise the sterility of the contents.
Acción
Each consignee will be notified of the recall by an Urgent Medical Device Recall Notification letter sent by FedEx or an equivalent method. The letter identified the affected product, explained the reason for recall, and health risk. Consignees were instructed to examine their inventory and segregate the affected product for return. Customers are to complete and return the Reply Form and to notify their customers if the product was further distributed. Consignees are instructed to return any remaining product to ConMed Linvatec. Questions should be directed to the Customer Service department at 800-535-8536.
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
Arthroscope - Product Code HRX
Causa
This recall was due to the possibility that multiple products may have a breach in the poly-tyvek pouch that could potentially compromise the sterility of the contents.
Acción
Each consignee will be notified of the recall by an Urgent Medical Device Recall Notification letter sent by FedEx or an equivalent method. The letter identified the affected product, explained the reason for recall, and health risk. Consignees were instructed to examine their inventory and segregate the affected product for return. Customers are to complete and return the Reply Form and to notify their customers if the product was further distributed. Consignees are instructed to return any remaining product to ConMed Linvatec. Questions should be directed to the Customer Service department at 800-535-8536.
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
Arthroscope - Product Code HRX
Causa
This recall was due to the possibility that multiple products may have a breach in the poly-tyvek pouch that could potentially compromise the sterility of the contents.
Acción
Each consignee will be notified of the recall by an Urgent Medical Device Recall Notification letter sent by FedEx or an equivalent method. The letter identified the affected product, explained the reason for recall, and health risk. Consignees were instructed to examine their inventory and segregate the affected product for return. Customers are to complete and return the Reply Form and to notify their customers if the product was further distributed. Consignees are instructed to return any remaining product to ConMed Linvatec. Questions should be directed to the Customer Service department at 800-535-8536.
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
Arthroscope - Product Code HRX
Causa
This recall was due to the possibility that multiple products may have a breach in the poly-tyvek pouch that could potentially compromise the sterility of the contents.
Acción
Each consignee will be notified of the recall by an Urgent Medical Device Recall Notification letter sent by FedEx or an equivalent method. The letter identified the affected product, explained the reason for recall, and health risk. Consignees were instructed to examine their inventory and segregate the affected product for return. Customers are to complete and return the Reply Form and to notify their customers if the product was further distributed. Consignees are instructed to return any remaining product to ConMed Linvatec. Questions should be directed to the Customer Service department at 800-535-8536.
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.
Complaints indicate product's distal threaded tip may fracture under certain circumstances.
Acción
DJO Surgical sent an "Urgent Field Safety Notice" Letter dated July 12, 2010, to all of their consignees. The letter described the product, the problem, and the action consignees should take. Consignees were instructed to:
Contact their Customer Service Representative for an R-RPR (RMS) number and return all RSP Glenoid Head Inserters, 804-03-041, under the assigned number to receive credit.
Complete and return the Field Safety Notice Response to the firm.
Identify and inform any customers who were sold or received the product of the Field Safety Notice
Any questions consignees should call the firm at (512) 834-6330.
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
Needle, Hypodermic, Single Lumen - Product Code FMI
Causa
Needle cannula may separate from the hub during use.
Acción
Recall letters requesting product return were mailed to all customers on October 8, 2004
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notas adicionales en la data
Introducer, Catheter - Product Code DYB
Causa
Potential for a partial or complete separation of the shaft (sheath) from the hub or a material break in the hub assembly just distal to the hemostasis seal. if either of these were to occur during use, it is likely that fluids would leak around the introducer hub and strain relief.
Acción
Consignees were sent "Urgent Medical Device Recall Notice" dated June 24, 2010 from St. Jude Medical . The letter was addressed to Cath Lab Manger/ Risk Manager. The letter described the problem and the product involved. Advised consignees to discontinue use of the product and remove from inventory.
Sales Representatives were also sent a St. Jude Medical Memorandum "Field Action Notice" dated June 24, 2010 and a reconciliation form. The memorandum described the problem and product. Advised Sales Rep to visit the affected accounts and to performed the assigned tasks.
A St. Jude Medical sales representative will be contacting for removal and replacement of the affected product. For additional information, please contact St. Jude Medical at 651-491-4470.
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
Introducer, Catheter - Product Code DYB
Causa
Potential for a partial or complete separation of the shaft (sheath) from the hub or a material break in the hub assembly just distal to the hemostasis seal. if either of these were to occur during use, it is likely that fluids would leak around the introducer hub and strain relief.
Acción
Consignees were sent "Urgent Medical Device Recall Notice" dated June 24, 2010 from St. Jude Medical . The letter was addressed to Cath Lab Manger/ Risk Manager. The letter described the problem and the product involved. Advised consignees to discontinue use of the product and remove from inventory.
Sales Representatives were also sent a St. Jude Medical Memorandum "Field Action Notice" dated June 24, 2010 and a reconciliation form. The memorandum described the problem and product. Advised Sales Rep to visit the affected accounts and to performed the assigned tasks.
A St. Jude Medical sales representative will be contacting for removal and replacement of the affected product. For additional information, please contact St. Jude Medical at 651-491-4470.
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
Introducer, Catheter - Product Code DYB
Causa
Potential for a partial or complete separation of the shaft (sheath) from the hub or a material break in the hub assembly just distal to the hemostasis seal. if either of these were to occur during use, it is likely that fluids would leak around the introducer hub and strain relief.
Acción
Consignees were sent "Urgent Medical Device Recall Notice" dated June 24, 2010 from St. Jude Medical . The letter was addressed to Cath Lab Manger/ Risk Manager. The letter described the problem and the product involved. Advised consignees to discontinue use of the product and remove from inventory.
Sales Representatives were also sent a St. Jude Medical Memorandum "Field Action Notice" dated June 24, 2010 and a reconciliation form. The memorandum described the problem and product. Advised Sales Rep to visit the affected accounts and to performed the assigned tasks.
A St. Jude Medical sales representative will be contacting for removal and replacement of the affected product. For additional information, please contact St. Jude Medical at 651-491-4470.
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
Introducer, Catheter - Product Code DYB
Causa
Potential for a partial or complete separation of the shaft (sheath) from the hub or a material break in the hub assembly just distal to the hemostasis seal. if either of these were to occur during use, it is likely that fluids would leak around the introducer hub and strain relief.
Acción
Consignees were sent "Urgent Medical Device Recall Notice" dated June 24, 2010 from St. Jude Medical . The letter was addressed to Cath Lab Manger/ Risk Manager. The letter described the problem and the product involved. Advised consignees to discontinue use of the product and remove from inventory.
Sales Representatives were also sent a St. Jude Medical Memorandum "Field Action Notice" dated June 24, 2010 and a reconciliation form. The memorandum described the problem and product. Advised Sales Rep to visit the affected accounts and to performed the assigned tasks.
A St. Jude Medical sales representative will be contacting for removal and replacement of the affected product. For additional information, please contact St. Jude Medical at 651-491-4470.
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
endoscopy accessory - Product Code FAT
Causa
The silicone sheath component of the product detaches from the catheter upon removal of the e-kit from the body.
Acción
On 5/11/10, Stryker Endoscopy initiated the recall notification letters explaining the reason for the recall and requesting the product be returned.
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
Introducer, Catheter - Product Code DYB
Causa
Potential for a partial or complete separation of the shaft (sheath) from the hub or a material break in the hub assembly just distal to the hemostasis seal. if either of these were to occur during use, it is likely that fluids would leak around the introducer hub and strain relief.
Acción
Consignees were sent "Urgent Medical Device Recall Notice" dated June 24, 2010 from St. Jude Medical . The letter was addressed to Cath Lab Manger/ Risk Manager. The letter described the problem and the product involved. Advised consignees to discontinue use of the product and remove from inventory.
Sales Representatives were also sent a St. Jude Medical Memorandum "Field Action Notice" dated June 24, 2010 and a reconciliation form. The memorandum described the problem and product. Advised Sales Rep to visit the affected accounts and to performed the assigned tasks.
A St. Jude Medical sales representative will be contacting for removal and replacement of the affected product. For additional information, please contact St. Jude Medical at 651-491-4470.
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
Sterilizer, chemical - Product Code MLR
Causa
Reliance eps had internal water leaks and interrupted cycles when air leaks triggered false fault 38 alarm that dg/hld cup has not been replaced.
Acción
Steris issued an "Urgent Field Correction Notice" dated July 2, 2010 to each affected US consignee, notifying them of the issue and affected device. Steris Field Service Representatives and Dealers will contact each affected customer to schedule a service visit to install system upgrades. In the event of an interrupted cycle prior to the upgrade, consignees were instructed that the load should be handled in accordance with the Reliance EPS Operators Manual. Steris can be contacted at 440-392-7043.
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
Ocular Surgery Irrigation Device - Product Code KYG
Causa
Insight instruments, inc., stuart, fl is recalling cornea coat 2.5% hydroxypropylmethylcellulose solution in 1.5 ml syringe due to a potential weakness of the peel pouch seals. products affected are item numbers 600100.000 sold individually and 40201.000 thru 10206.000 sold as components of biom pack.
Acción
All consignees were notified of the recall by letter sent via first class mail. Letter contained a Return Response Form.
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
Ocular Surgery Irrigation Device - Product Code KYG
Causa
Insight instruments, inc., stuart, fl is recalling cornea coat 2.5% hydroxypropylmethylcellulose solution in 1.5 ml syringe due to a potential weakness of the peel pouch seals. products affected are item numbers 600100.000 sold individually and 40201.000 thru 10206.000 sold as components of biom pack.
Acción
All consignees were notified of the recall by letter sent via first class mail. Letter contained a Return Response Form.
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
Immunoglobulin A (Ig-A) Reagent - Product Code DEW
Causa
The recall was initiated after beckman coulter inc. confirmed reports of high recovery of immunoglobulin a (iga) in proficiency surveys or patient samples using synchron ig-a reagent lots m812164 or m902345. using these reagent lots, some samples deficient in iga have yielded results in the normal range.
other samples with normal levels of iga have yielded falsely high results.
Acción
A Product Corrective Action (PCA) letter was sent on the week of June 28, 2010 to the affected customers. The letter provided the customers with an explanation of the problem identified and advised customers to discontinue use of the affected lots of the SYNCHRON System(s) Immunoglobulin A (Ig-A) Reagent.
Customers were instructed to:
(1) Discontinue use of Ig-A reagent lots M812164 and M902345. Contact your Customer Service Representative at (800) 526-3821 in the United States or (800) 463-7828 in Canada or contact your local Beckman Coulter Representative to discuss reagent replacement options.
(2) You may need to re-evaluate samples for IgA that were tested with either of the listed lots of Ig-A reagent.
(3) Please complete and return the enclosed response form within 10 days so that we may maintain our records.
Customers were also instructed to share this information with your laboratory staff and retain this notification as part of your
Quality System documentation. If you have forwarded the affected products listed above to another laboratory, please provide a copy of this letter to them. If they have any questions regarding this Product Corrective Action letter, customers were told to contact our Customer Support Center (Call Center) on the Beckman Coulter website at www.BeckmanCoulter.com/Customer Support/Support Requests, or call (800) 854-3633 in the
United States and Canada.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notas adicionales en la data
Wire, Guide, Catheter - Product Code DQX
Causa
Incorrectly assembled 18 ga x 2 1/2 introducer needle.
Acción
The recalling firm issued an Urgent Medical Device Recall letter dated 7/23/2010 along with a a recall acknowledgement and stock status form.
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 recall was initiated after osypka medical received two (2) complaints from their japanese distributor
regarding an incompatibility of the pace 203h with some new types of 9 v batteries.
the investigation revealed that pace 203h of a certain manufacturing period malfunction
(i.E., not stimulate) when a type of 9 v batteries with higher than usual open circuit voltage (ocv) is used. failure t.
Acción
OSYPKA Medical sent "Urgent Medical Device Recall" letters dated June 30, 2010 and July 7, 2010 to the direct customers. The recall notice informed the customers of the Reason for Recall, the Potential Hazard, the Temporary Fix of the Problem, the Permanent Fix of the Problem and Recommended Actions to be taken by the customer.
The customers were instructed to contact Osypka Medical via telephone (858) 454-0021 or e-mail to m.osypka@osypkamed.com to verify that the Model 3085 and/or PACE 203H is subject to this product removal, obtain a return-to-manufacturer-authorization (RMA) number ,and then return the affected devices to Osypka Medical.
If you have any questions call (858) 454-0021 or e-mail to
mail@osypkamed.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
Implanted Subcutaneous Intravascular Port & Catheter - Product Code LJT
Causa
Recalled product was packaged with the incorrect port and does not match the label. the kit is labeled as a 6.6f "dignity" low profile ct port. the kit contains a 6.6f "pro-fuse" low profile ct port.
Acción
Medcomp sales reps and foreign distributor were notified via email on 7/1/10. Product is to be returned to Medcomp.
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.
Updated instructions for use- heartstart mrx monitor/defibrillator. the update provides more detailed information on:
" default ecg lead behavior
" synchronized cardioversion using external paddles.
Acción
Philips issued an Urgent Voluntary Medical Device Correction notification/Field Safety Notice and an Instructions for Use Addendum on July 20, 2010, to affected customers. The Notice identified the product, the problem, and the action customers should take. In the USA, the notification sent to all affected customers via UPS and confirmation of delivery would be tracked. Outside the USA, Philips representatives in the affected geographies would manage their mailings locally. Customers were instructed to review the HeartStart MRx Instructions for Use addendum and keep a copy with their equipment - Instructions for Use. Additionally, they were instructed to insure that all users are fully trained on the MRx and, in particular, ensure that they review and understand have reviewed and understand the additional detail provided in the notification.
For questions regarding this recall call (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.
Fluid may enter the multi-functional handle (opti grip) when using the axiom luminos tf or sireskop sd system, causing unintended reaction or movement, increased radiation or useless images.
Acción
Siemens Healthcare Sector sent an "Urgent Field Safety Notice" to consignees describing the issue and informing them to take specific precautions when performing interventional procedures to avoid fluids penetrating the system. The multi-functional handle (Opti Grip) will be replaced through implementation of Update Instructions AX030/10/S. The modified version of the handle resists fluids from entering the handle and prevents malfunction.
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
Magnetic Resonance Diagnostic Device - Product Code LNH
Causa
Electronic box on headstrap may overheat, causing burn to patient.
Acción
Customers were notified by letter on 07/07/2010, advising them of the overheating problem and alerting them that a service rep will be visiting to inspect and upgrade any affected FlexiCoils. Questions were referred to 800-595-9709.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notas adicionales en la data
Wire, Guide, Catheter - Product Code DQX
Causa
Incorrectly assembled 18 ga x 2 1/2 introducer needle.
Acción
The recalling firm issued an Urgent Medical Device Recall letter dated 7/23/2010 along with a a recall acknowledgement and stock status form.
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
infusion pump and monitor - Product Code FRN
Causa
Under certain wireless network conditions a communication error can occur, which freezes the pc unit screen, which may result in a delay of therapy. a delay of therapy may result in serious injury and/or death. carefusion identified this potential risk associated with the alaris pc unit model 8015 only (pc unit) manufactured between december-2008 and september-2009.
Acción
CareFusion sent the customer notification letter to all customers using the affected Alaris PC Unit beginning August 24, 2010. The customer notification letter is addressed to the Directors of Nursing, Risk Management, and Biomedical Engineering. Customers will be required to confirm receipt of the notification by returning the Recall Response Card to CareFusion by postage-paid, self-addressed mail, fax or email.
The recall notice informed the customers of the reason for the notice, the units affected, the potential risk, a step-by-step description of the issue and the required actions for users.
The customers were also told that CareFusion will contact their facility through phone or in person within 60 days to initiate implementation of the corrective action. The corrective action will require a hardware update to all affected units. CareFusion does not require that you return your devices. In the interim, if you observe this issue, remove the device from service and contact CareFusion Recall Center immediately.
Customers were also told that any adverse reactions experienced with the use of this product, and/or quality problems should also be reported to the FDA's MedWatch Program.
The recall notice provided contact information for CareFusion's Recall Center, Customer Advocacy and Technical Support units.
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
Mesh, surgical - Product Code FTM
Causa
Mislabeled -one lot of product labeled as 8 cm x 8 cm were actually cut using a 6 cm x 6 cm template.
Acción
LifeCell issued Recall Notice letters dated July 12, 2010 to customers, identifying the affected product, the labeling issue, and actions to be taken by the customer. Two versions of the recall notification were sent, one for implanted units and one for those not yet implanted. Both letters stated that the mislabeling has no impact of the safety or effectiveness of the medical device.
Replacement units were offered for all affected units.
Those with unused units were to contact LifeCell Customer Solutions for return and replacement of the unit at 1-866-423-2433.
Those with implanted units may contact LifeCell Customer Solutions at 1-866-423-2433 with any additional questions or concerns.