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
Apparatus, exhaust, surgical - Product Code FYD
Causa
Stryker has received two reports of serious injury as a result of tissue damage associated with the use of the neptune 2, including an event in which one customer connected the neptune 2 system to a passive chest drainage tube post operatively, resulting in a fatality. the current ifu did not specifically warn against connecting all neptune waste management devices, which is a high vacuum/high flow device, to a passive drainage tube. june 12, 2012, customers were instructed to review the revised ifu, distribute to affected departments, and educate users of the neptune on this warning. warning labels, which are pending distribution, are required on all neptune devices.
further investigation found the neptune 1 silver, neptune 2 ultra (120v) and neptune 2 ultra (230v) lacked fda 510(k) clearance and therefore are not legally marketed without determination of their safety and effectiveness. fda advises neptune 1 silver, neptune 2 ultra (120v) and neptune 2 ultra (230v) not be used. however, customers who do not have an alternative device to use should weigh the risks and benefits associated with continued use of these devices. if customers choose to continue use of the neptune silver, neptune 2 ultra (120v) or neptune 2 (230v), they must complete a certificate of medical necessity and return it to stryker by october 12, 2012.
Acción
On June 5, 2012, Stryker notified customers that it was recalling the IFUs for the above products. The current IFU did not specifically warn against connecting the Neptune Rover, which is a high vacuum/high flow device, to a passive drainage tube. Customers were instructed to review the revised IFU, distribute to affected departments, and educate users of the Neptune on this warning. Customers must confirm with Stryker via business reply form that they have completed these actions.
Customers who have the Neptune 1 Gold, Neptune 1 Gold International or Neptune 2 Bronze will receive a follow up mailing containing warning labels for the device and instructions detailing how to apply them. Customers may continue to use the Neptune 1 Gold, Neptune 1 Gold International, and the Neptune 1 Bronze without any further actions.
On September 18, 2012, Stryker notified customers via letter delivered by FedEx overnight delivery that it is expanding the recall on the Neptune 1 Silver, Neptune 2 Ultra (120V) and Neptune 2 Ultra (230V) because FDA has also advised Stryker that these devices require, but do not currently have, 510(k) clearance. FDA is therefore unable to determine whether these devices are as safe and effective as their legally marketed predicate, the Neptune 1 (Gold) Waste Management System (510(k) K012992). As such, Stryker has ceased distribution of the Neptune Silver, Neptune 2 Ultra (120V) and Neptune 2 Ultra (230V) devices until FDA clears these devices.
At this time, FDA does not consider the Neptune Silver, the Neptune 2 Ultra (120V) or the Neptune 2 Ultra (230V) to be legally marketed devices because their safety and effectiveness have not yet been determined. As such, FDA advises that the devices not be used. However, customers who do not have an alternative device to use should weigh the risks and benefits associated with continued use of these devices. If customers choose to continue use of the Neptune Silver, Neptune 2 Ultra (120V) or Nept
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
Gown, surgical - Product Code FYA
Causa
The clear tape, that is intended to aid in the prevention of patients fluids from contacting the surgeon/surgical staff through the sleeve seam of the toga, was not applied during the manufacturing process. stryker has received 5 complaints associated with the defective seams which allowed bleed through of bodily fluids.
Acción
Stryker sent the May 29,2012 URGENT MEDICAL DEVICE RECALL NOTIFICATION and the June 14, 2012 REVISED URGENT MEDICAL DEVICE RECALL Notice to all consignees. The letters identified the affected products, problem and actions to be taken. The Revised letter instructed customers to find, quarantine, make product unusable and destroy all implicated product . Replacement products may not immediately available. Customers were asked to complete and sign the Business Reply Form (BFR) and fax to Stryker Instruments Regulatory Department at 866-521-2762. If the affected products have been further distributed, forward this notification letter and the attached BRF to all affected locations. Questions should be addressed to Angela Ragainis, 269-389-4354; angela.ragainis@stryker.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
Injector, vertebroplasty (does not contain cement) - Product Code OAR
Causa
Additional instructions for use and surgical technique for the confidence needle due to reports of breakage with the side fire needles.
Acción
Depuy Spine sent a "CORRECTION NOTICE" to all affected customers. The letter identifies the product, problem, and actions to be taken by the customers. A Field Correction Notification Form was attached for customers to complete and return via fax to 508-828-3070. For questions about Confidence Needles, please contact your local DePuy Spine Sales Representative. If you need assistance in locating your local Sales Representative please contact JJHCS CIS @ 1 -800-255 -2500 .
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
Beauty Angel - Product Code 000
Causa
The beauty angel was marketed without a 510k.
Acción
JK Products sent a Mandatory Field Correction Notice - Immediate Action Required letter dated February 10, 2012, to all affected customers. The letter identified the product the problem, and the action to be taken by the customer. The firm instructed customers that they would be replacing the operating instructions for the affected product with new ones that meet the requirements defined by the regulatory authorities. Customers were instructed not to make claims that indicate that using the affected product will result in medical or health benefits, or that directly or indirectly imply that the affected product is intended to cure, treat, diagnose or pevent an illness, or disease. Customers were asked to complete the new owner information request on the return post care enclosed and return to the firm. If product was further distributed those accounts should be contacted immediately and should be advised of this Mandatory Field Correction Notice. For questions customers should call 870-935-1130. For questions regarding this recall call 870-268-2702.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notas adicionales en la data
System, x-ray, tomography, computed - Product Code JAK
Causa
On 3/5/2012, philips healthcare was notified of one incident involving a brilliance ict scanner that resulted in damage to the gantry and slight injury to the user when the heat exchanger detached from the cooling unit due to some missing welds.
Acción
Philips Healthcare sent an "URGENT- MEDICAL DEVICE CORRECTION" letter dated May 8, 2012 to all affected customers. The letter identifies the product and problem. No action is required by the customers. Additionally, a Field Service Engineer will contact each site to schedule time to implement the Field Change Order. Philips Healthcare will inspect the cooling units on all iCT and iCT SP systems for this issue and if the welds on a cooling unit do not pass the inspection, Philips will replace the cooling unit free of charge.
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 device was marketed without a 510(k) and is not sterile.
Acción
MEDDEV USA, Inc decided to recall and notified their customer by phone on 05/10/12. Customers were instructed to return the entire shipment to MEDDEV .
For questions regarding this recall call 214-692-3559.
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
Vibrator, therapeutic - Product Code IRO
Causa
Non-invasive monitoring systems inc (nims) is voluntarily recalling promotional materials which contain unsubstantiated direct and indirect claims.
Acción
NiMS sent an Urgent Promotional Material Recall letter dated May 29, 2012, to all affected customers. NIMS contacted the 18 facilities by phone starting on May 29, 2012 and sent the 73 end users letters dated May 29, 2012. NiMS instructed customers to immediately examine their inventory and quarantine any of the US-001 or USA-002 brochures. If customers further distributed brochures customers were instructed to notify their customers at once by including a copy of the recall notification letter. Customers were requested to destroy all Exer-Rest promotional materials.
For any questions customers were instructed to call 305-575-4204.
For questions regarding this recall call 305-575-4201.
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
Vibrator, therapeutic - Product Code IRO
Causa
Non-invasive monitoring systems inc (nims) is voluntarily recalling promotional materials which contain unsubstantiated direct and indirect claims.
Acción
NiMS sent an Urgent Promotional Material Recall letter dated May 29, 2012, to all affected customers. NIMS contacted the 18 facilities by phone starting on May 29, 2012 and sent the 73 end users letters dated May 29, 2012. NiMS instructed customers to immediately examine their inventory and quarantine any of the US-001 or USA-002 brochures. If customers further distributed brochures customers were instructed to notify their customers at once by including a copy of the recall notification letter. Customers were requested to destroy all Exer-Rest promotional materials.
For any questions customers were instructed to call 305-575-4204.
For questions regarding this recall call 305-575-4201.
Cuban data is current through 2018. All of the data comes from the Health Ministry of Cuba, 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 Cuba.
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
Gown, surgical - Product Code FYA
Causa
The clear tape, that is intended to aid in the prevention of patients fluids from contacting the surgeon/surgical staff through the sleeve seam of the toga, was not applied during the manufacturing process. stryker has received 5 complaints associated with the defective seams which allowed bleed through of bodily fluids.
Acción
Stryker sent the May 29,2012 URGENT MEDICAL DEVICE RECALL NOTIFICATION and the June 14, 2012 REVISED URGENT MEDICAL DEVICE RECALL Notice to all consignees. The letters identified the affected products, problem and actions to be taken. The Revised letter instructed customers to find, quarantine, make product unusable and destroy all implicated product . Replacement products may not immediately available. Customers were asked to complete and sign the Business Reply Form (BFR) and fax to Stryker Instruments Regulatory Department at 866-521-2762. If the affected products have been further distributed, forward this notification letter and the attached BRF to all affected locations. Questions should be addressed to Angela Ragainis, 269-389-4354; angela.ragainis@stryker.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
System, x-ray, tomography, computed - Product Code JAK
Causa
Philips is issuing a software update (version 3.2.4) to the brilliance ict and ict sp systems currently running software version 3.2.0, 3.2.1 or 3.2.3, addressing a number of non-conformances. a review was conducted of all nonconformances that are fixed by the software upgrade. none of these nonconformances result in unacceptable hazards.
the nonconformance documented below had the highest sc.
Acción
Philips sent an Urgent - Medical Device Correction letter dated May 8, 2012, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Philips Key Market representatives will distribute the letter internationally. Additionally, a Field Service Engineer will contact each site to schedule time to implement the Field Change Order. Customers were instructed to review the Release Document provided them with information about the software update, new feature and enhancements.
For North America and Canada customers should contact the Customer Care Solutions Center (1-800-722-9377, option 5: Enter Side ID or follow the prompts.
For questions regarding this recall call 440-483-4918.
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
Injector, vertebroplasty (does not contain cement) - Product Code OAR
Causa
Additional instructions for use and surgical technique for the confidence needle due to reports of breakage with the side fire needles.
Acción
Depuy Spine sent a "CORRECTION NOTICE" to all affected customers. The letter identifies the product, problem, and actions to be taken by the customers. A Field Correction Notification Form was attached for customers to complete and return via fax to 508-828-3070. For questions about Confidence Needles, please contact your local DePuy Spine Sales Representative. If you need assistance in locating your local Sales Representative please contact JJHCS CIS @ 1 -800-255 -2500 .
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
Injector, vertebroplasty (does not contain cement) - Product Code OAR
Causa
Additional instructions for use and surgical technique for the confidence needle due to reports of breakage with the side fire needles.
Acción
Depuy Spine sent a "CORRECTION NOTICE" to all affected customers. The letter identifies the product, problem, and actions to be taken by the customers. A Field Correction Notification Form was attached for customers to complete and return via fax to 508-828-3070. For questions about Confidence Needles, please contact your local DePuy Spine Sales Representative. If you need assistance in locating your local Sales Representative please contact JJHCS CIS @ 1 -800-255 -2500 .
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
Injector, vertebroplasty (does not contain cement) - Product Code OAR
Causa
Additional instructions for use and surgical technique for the confidence needle due to reports of breakage with the side fire needles.
Acción
Depuy Spine sent a "CORRECTION NOTICE" to all affected customers. The letter identifies the product, problem, and actions to be taken by the customers. A Field Correction Notification Form was attached for customers to complete and return via fax to 508-828-3070. For questions about Confidence Needles, please contact your local DePuy Spine Sales Representative. If you need assistance in locating your local Sales Representative please contact JJHCS CIS @ 1 -800-255 -2500 .
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
Table, radiographic, tilting - Product Code IXR
Causa
If a lead ruler is not positioned in the same plane as the anatomical image detail to be measured, measured object distances (using the ruler) can be wrong by a corresponding factor. if, additionally, the measurement tool is not used to check the ruler, or is used in the right way (ie: calibration), such calibration error is not detected. as a result of this, a surgical intervention may be execut.
Acción
Philips sent an Urgent - Field Safety Notice letter dated May 11, 2012 to their affected customers. The letter identified the affected product, what the issues are, under what circumstances they may occur and the actions to be taken to avoid or minimize the occurrence of the issue Philips plans to supply an Addendum to the Instruction for Use. A Philips Service Engineer will contact the affected customers as soon as the Field Action Kit is ready to be implemented. For questions contact your local Philips representative: Technical Support Line 1-800-722-9377.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notas adicionales en la data
Radioassay, vitamin b12 - Product Code CDD
Causa
Siemens healthcare diagnostics has confirmed that the presence of intrinsic factor blocking antibody in some patients can result in a false and significant elevation in the reported concentration of vitamin b12 on the dimension vista system. this issue affects all lots of b12 flex reagent cartridges on the dimension vista system.
Acción
Siemens Healthcare Diagnostics Inc. sent a Urgent Device Recall letter to all affected customers dated May 2012. The letter identified the product the problem and the action needed to be taken by the customer.
The letter instructed customers to immediately discontinue use of the device, quarantine and dispose of all inventory, ensure that your Medical Director reviews this letter as well as the attached physician letter. Please complete the attached Field Correction form and fax to 302-631-8467.
Further questions please call 302-631-6311.
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
Tubing, fluid delivery - Product Code FPK
Causa
Moog medical device group became aware on march 23, 2012 via customer complaint, of a reversed pump segment on an administration set. this malfunction could reverse the flow of fluid or medication backwards from what was intended.
Acción
The firm, Moog Medical Device Group, sent an "Urgent Field Safety Notice" dated May 21, 2012 via certified letter and a press release direct to consignees/customers. The notice describes the product, problem and actions to be taken. The customers were instructed to do the following:
If purchased by distributor -remove suspect product from inventory; contact your distributor to arrange replacement product and request a shipping return label as per the distributor's process and ship product to their location.
If purchased by Moog-remove suspect product from inventory, contact Moog Customer Service at 1-800-970-2337, prompt #7 and Moog customer service will provide a call tag for convenient product return.
For additional information or clarification, please contact the Post Market Surveillance Manager at (801) 264-1001, ext. 224 or via email at: lbrewer@moog.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
Tubing, fluid delivery - Product Code FPK
Causa
Moog medical device group became aware on march 23, 2012 via customer complaint, of a reversed pump segment on an administration set. this malfunction could reverse the flow of fluid or medication backwards from what was intended.
Acción
The firm, Moog Medical Device Group, sent an "Urgent Field Safety Notice" dated May 21, 2012 via certified letter and a press release direct to consignees/customers. The notice describes the product, problem and actions to be taken. The customers were instructed to do the following:
If purchased by distributor -remove suspect product from inventory; contact your distributor to arrange replacement product and request a shipping return label as per the distributor's process and ship product to their location.
If purchased by Moog-remove suspect product from inventory, contact Moog Customer Service at 1-800-970-2337, prompt #7 and Moog customer service will provide a call tag for convenient product return.
For additional information or clarification, please contact the Post Market Surveillance Manager at (801) 264-1001, ext. 224 or via email at: lbrewer@moog.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
Snare, flexible - Product Code FDI
Causa
Difficulty in extending snare loop from the catheter.
Acción
Boston Scientific issued an Urgent Medical Device Recall Action letter via Federal Express Priority mail on May 16, 2012. The notification instructs the account to check their inventory, remove any affected product from their inventory, and return it to Boston Scientific. The notification also requests the completion of a Reply Verification Tracking Form. Scan and fax to 508-683-5578.
For questions regarding this recall call 508-683-8000.
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
Tubing, fluid delivery - Product Code FPK
Causa
Moog medical device group became aware on march 23, 2012 via customer complaint, of a reversed pump segment on an administration set. this malfunction could reverse the flow of fluid or medication backwards from what was intended.
Acción
The firm, Moog Medical Device Group, sent an "Urgent Field Safety Notice" dated May 21, 2012 via certified letter and a press release direct to consignees/customers. The notice describes the product, problem and actions to be taken. The customers were instructed to do the following:
If purchased by distributor -remove suspect product from inventory; contact your distributor to arrange replacement product and request a shipping return label as per the distributor's process and ship product to their location.
If purchased by Moog-remove suspect product from inventory, contact Moog Customer Service at 1-800-970-2337, prompt #7 and Moog customer service will provide a call tag for convenient product return.
For additional information or clarification, please contact the Post Market Surveillance Manager at (801) 264-1001, ext. 224 or via email at: lbrewer@moog.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
Tubing, fluid delivery - Product Code FPK
Causa
Moog medical device group became aware on march 23, 2012 via customer complaint, of a reversed pump segment on an administration set. this malfunction could reverse the flow of fluid or medication backwards from what was intended.
Acción
The firm, Moog Medical Device Group, sent an "Urgent Field Safety Notice" dated May 21, 2012 via certified letter and a press release direct to consignees/customers. The notice describes the product, problem and actions to be taken. The customers were instructed to do the following:
If purchased by distributor -remove suspect product from inventory; contact your distributor to arrange replacement product and request a shipping return label as per the distributor's process and ship product to their location.
If purchased by Moog-remove suspect product from inventory, contact Moog Customer Service at 1-800-970-2337, prompt #7 and Moog customer service will provide a call tag for convenient product return.
For additional information or clarification, please contact the Post Market Surveillance Manager at (801) 264-1001, ext. 224 or via email at: lbrewer@moog.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
Tubing, fluid delivery - Product Code FPK
Causa
Moog medical device group became aware on march 23, 2012 via customer complaint, of a reversed pump segment on an administration set. this malfunction could reverse the flow of fluid or medication backwards from what was intended.
Acción
The firm, Moog Medical Device Group, sent an "Urgent Field Safety Notice" dated May 21, 2012 via certified letter and a press release direct to consignees/customers. The notice describes the product, problem and actions to be taken. The customers were instructed to do the following:
If purchased by distributor -remove suspect product from inventory; contact your distributor to arrange replacement product and request a shipping return label as per the distributor's process and ship product to their location.
If purchased by Moog-remove suspect product from inventory, contact Moog Customer Service at 1-800-970-2337, prompt #7 and Moog customer service will provide a call tag for convenient product return.
For additional information or clarification, please contact the Post Market Surveillance Manager at (801) 264-1001, ext. 224 or via email at: lbrewer@moog.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
Tubing, fluid delivery - Product Code FPK
Causa
Moog medical device group became aware on march 23, 2012 via customer complaint, of a reversed pump segment on an administration set. this malfunction could reverse the flow of fluid or medication backwards from what was intended.
Acción
The firm, Moog Medical Device Group, sent an "Urgent Field Safety Notice" dated May 21, 2012 via certified letter and a press release direct to consignees/customers. The notice describes the product, problem and actions to be taken. The customers were instructed to do the following:
If purchased by distributor -remove suspect product from inventory; contact your distributor to arrange replacement product and request a shipping return label as per the distributor's process and ship product to their location.
If purchased by Moog-remove suspect product from inventory, contact Moog Customer Service at 1-800-970-2337, prompt #7 and Moog customer service will provide a call tag for convenient product return.
For additional information or clarification, please contact the Post Market Surveillance Manager at (801) 264-1001, ext. 224 or via email at: lbrewer@moog.com.
Cuban data is current through 2018. All of the data comes from the Health Ministry of Cuba, 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 Cuba.
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
Tubing, fluid delivery - Product Code FPK
Causa
Moog medical device group became aware on march 23, 2012 via customer complaint, of a reversed pump segment on an administration set. this malfunction could reverse the flow of fluid or medication backwards from what was intended.
Acción
The firm, Moog Medical Device Group, sent an "Urgent Field Safety Notice" dated May 21, 2012 via certified letter and a press release direct to consignees/customers. The notice describes the product, problem and actions to be taken. The customers were instructed to do the following:
If purchased by distributor -remove suspect product from inventory; contact your distributor to arrange replacement product and request a shipping return label as per the distributor's process and ship product to their location.
If purchased by Moog-remove suspect product from inventory, contact Moog Customer Service at 1-800-970-2337, prompt #7 and Moog customer service will provide a call tag for convenient product return.
For additional information or clarification, please contact the Post Market Surveillance Manager at (801) 264-1001, ext. 224 or via email at: lbrewer@moog.com.