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.
Zimmer had received complaints that reported breakage of the persona knee trial articular surface provisionals (tasps). this is a retrospective recall which covers zimmer's corrective actions taken earlier this year concerning the tasps.
Acción
On February 10, 2014, Zimmer sent letter to surgeons who had filed complaints regarding the affected TASP fractures. The letter provided the surgeons with Zimmer's investigational findings of the issue. Surgeons were directed to send questions or any additional informtion to Zimmer.PER@Zimmer.com. The Zimmer Weekly Wrap-Up, dated February 14, 2014, was issued electronically to sales force. They were notified to engage in mandatory training to improve the usage of the TASPs and prevent potential breakage. Zimmer has taken additional corrective measures by initiating another recall in July 2014 whereby they notify the distributors as well as all users of the enhanced surgical technique.
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.
Zimmer had received complaints that reported breakage of the persona knee trial articular surface provisionals (tasps). this is a retrospective recall which covers zimmer's corrective actions taken earlier this year concerning the tasps.
Acción
On February 10, 2014, Zimmer sent letter to surgeons who had filed complaints regarding the affected TASP fractures. The letter provided the surgeons with Zimmer's investigational findings of the issue. Surgeons were directed to send questions or any additional informtion to Zimmer.PER@Zimmer.com. The Zimmer Weekly Wrap-Up, dated February 14, 2014, was issued electronically to sales force. They were notified to engage in mandatory training to improve the usage of the TASPs and prevent potential breakage. Zimmer has taken additional corrective measures by initiating another recall in July 2014 whereby they notify the distributors as well as all users of the enhanced surgical technique.
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.
Zimmer had received complaints that reported breakage of the persona knee trial articular surface provisionals (tasps). this is a retrospective recall which covers zimmer's corrective actions taken earlier this year concerning the tasps.
Acción
On February 10, 2014, Zimmer sent letter to surgeons who had filed complaints regarding the affected TASP fractures. The letter provided the surgeons with Zimmer's investigational findings of the issue. Surgeons were directed to send questions or any additional informtion to Zimmer.PER@Zimmer.com. The Zimmer Weekly Wrap-Up, dated February 14, 2014, was issued electronically to sales force. They were notified to engage in mandatory training to improve the usage of the TASPs and prevent potential breakage. Zimmer has taken additional corrective measures by initiating another recall in July 2014 whereby they notify the distributors as well as all users of the enhanced surgical technique.
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
Accelerator, linear, medical - Product Code IYE
Causa
Accuray is voluntarily recalling tomotherapy h series software versions 1.2.0, 1.2.1 and 1.2.2 (hi-art¿ 4.2.0, 4.2.1 and 4.2.2).
accuray has identified potential safety issues (anomalies) with these software versions.
Acción
Consignees were sent an Accuray "Urgent Device Correction" letter dated July 16, 2014. The letter was addressed to TomoTherapy System Medical Physicist. The letter described the Purpose of this letter, Description of the Potential Problems, Safety Instructions and software upgrade information. For questions or concerns they can contact Accuray Customer Support at 1-877-668-8667 (USA) or 1-408-716-4700(non-USA) or customersupport@accuray.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
Accelerator, linear, medical - Product Code IYE
Causa
Accuray is voluntarily recalling tomotherapy h series software versions 2.0.0 and 2.0.1 (hi-art¿ 5.0.0 and 5.0.1). accuray has identified potential safety issues (anomalies) with these software versions.
Acción
Accuray sent an "Urgent Device Correction" letter dated July 16, 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customers.
These anomalies will be corrected with a new software version.
You will be contacted by Accuray Customer Support to schedule a software upgrade to your system.
If you have any questions or concerns regarding this issue, please do not hesitate to contact Accuray Customer Support at +1.877.668.8667 (USA) or +1.408.716.4700 (non-USA) or customersupport@accuray.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
The following software issues have been identified in the affected products.
problem 1: when reopening a bookmark generated from processing a muga (multi-gated acquisition) scan within the nm cardiac application, the ejection fraction (ef) displayed should be the same as the ejection fraction (ef) originally displayed when the bookmark was first created. in some instances, the ejection fraction (.
Acción
Philips Healthcare issued an Urgent Medical Device Correction letter dated July 28, 2014, via certified mail to all affected consignees. The letter identified the product, the problem, and the action to be taken by the consignee. Philips Key Market representative would distribute the FSN internationally. Additionally, a Field Service Engineer would contact each site to schedule a time to install the software update.
Customers with questions were instructed to contact their local Philips representataive or local Philips Healthcare office. For North America and Canada customers were instructed to contact the Customer Care Solutions Center at 1-800-722-9377, option 1.
For questions regarding this recall call 978-659-7703.
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.
Integra lifesciences has identified through an internal investigation that some colored lids for integra container
systems were not yet cleared by the fda for sale and were inadvertently distributed.
Acción
Integra sent an Urgent Voluntary Medical Device Recall letter dated July 30, 2014, to the affected customer. The letter identified the product, the problem, and the action to be taken by the customer. The customer was instricted if they have distributed the affected product, they should identify those customers adn forward a copy of the Integra Medical Device Recall Notice to them. The customer was also instructed to complete the attached form and return by email FCA@integralife.come or FAX to 1-609-275-9445. For questions the customer was asked to contact Customer Service at 1-855-532-1723.
For questions regarding this recall call 717-840-9335.
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
Heater, breathing system w/wo controller (not humidifier or nebulizer - Product Code BZE
Causa
The carefusion airlife heated infant breathing circuit is being recalled due to a regulatory compliance risk involving a material change. the changes to the gas pathway may potentially impact the safety of the device and quality of the gas condensates to the patient.
Acción
CareFusion sent an URGENT: PRODUCT RECALL letters dated July 31, 2014 to all affected customers. The letters instructed customers to: 1) perform a 100% physical inventory to verify if any of the affected product codes are in stock; 2) complete and return the attached Recall Response Form within 15 days; 3) notify any customers/parties that the recalled products were distributed to of the recall; 4) distributors should have all their customers return the products and a completed Recall Response Form to the distributor for credit; and, 5) customers should destroy the recalled products according to their disposal procedure. If a customers procedure(s) does not allow for the destruction of the recalled products, the customers was advised to contact CareFusion AirLife Customer Support at 800-323-9088 (Monday - Friday, 8:00 AM - 5:00 PM CST) for product return options. Customers will receive credit for all destroyed products. Direct accounts with questions about this recall should contact CareFusion AirLife Customer Support at 800-323-9088 (Monday - Friday, 8:00 AM - 5:00 PM CST) for additional information.
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.
Zimmer received a trend of complaints indicating corrosion of product.
Acción
Zimmer issued an Urgent Medical Device Recall-Lot Specific notification via e-mail/letter dated July 19, 2014, to all affected customers. The notification identified the product the problem and the action needed to be taken by the customer.
All distributors were notified via electronic mail. Hospital risk managers and surgeons, as well as distributors with affected inventory were notified via courier. Distributors were sent a letter identifying the issue and their responsibilities. These responsibilities include locating and removing the affected product in their territory as well as identifying hospitals and surgeons who have previously used the affected product. Distributors are to return on-hand affected products to Zimmer, and ensure all of their products are accounted for using the form provided in the letter. Hospital risk managers and surgeons were provided with a letter identifying the issue and their responsibilities. These responsibilities include locating the affected product, quarantining the product, and returning it to their Zimmer sales representative.
If you have questions or concerns regarding this recall please call the customer call center at 1-877-946-2761.
Data from the Philippines is current through 2019. All of the data comes from the Food and Drug Administration Philippines, 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 Philippines.
Notas adicionales en la data
Causa
Fda advisory no. 2018-043
voluntary recall of innova™ 180 mm & 200 mm self-expanding stent system
all are hereby advised by the food and drug administration (fda) about the voluntary recall of innovatm stent system with attached sizes distributed by boston scientific philippines, inc., with business address at unit 2503 antel global corporate center, julia vargas, avenue, ortigas center, pasig city 1605 with the following information:
the cited medical device was voluntarily recalled by boston scientific philippines, inc. after partial deployment occurs when the stent is unable to be fully released from the delivery system. part of the stent can become anchored in the vessel while the rest of the stent remains within the delivery system. the most common reported injury has been additional medical or minor surgical intervention, vessel trauma or prolongation of the implant procedure. in certain cases boston scientific philippines, inc. received reports of major surgery to retrieve the stent/delivery system or to correct vascular compromise.
distributors, retailers, hospitals that have any lot of the stated medical device product are instructed to discontinue further distribution, sale and use. all consumers are likewise advised not to purchase or use the affected product lots.
any suspected adverse reaction experienced or any incident of the same cases from the use of the device but not limited to the lots stated above, should be reported immediately to fda at telephone no. (02) 857-1900 loc. 8301 or email us at this email address is being protected from spambots. you need javascript enabled to view it.
.
dissemination of the information to all concerned is requested.
attachments:
fda advisory no. 2018-043.Pdf.
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.
Zimmer received a trend of complaints indicating corrosion of product.
Acción
Zimmer issued an Urgent Medical Device Recall-Lot Specific notification via e-mail/letter dated July 19, 2014, to all affected customers. The notification identified the product the problem and the action needed to be taken by the customer.
All distributors were notified via electronic mail. Hospital risk managers and surgeons, as well as distributors with affected inventory were notified via courier. Distributors were sent a letter identifying the issue and their responsibilities. These responsibilities include locating and removing the affected product in their territory as well as identifying hospitals and surgeons who have previously used the affected product. Distributors are to return on-hand affected products to Zimmer, and ensure all of their products are accounted for using the form provided in the letter. Hospital risk managers and surgeons were provided with a letter identifying the issue and their responsibilities. These responsibilities include locating the affected product, quarantining the product, and returning it to their Zimmer sales representative.
If you have questions or concerns regarding this recall please call the customer call center at 1-877-946-2761.
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.
Zimmer received a trend of complaints indicating corrosion of product.
Acción
Zimmer issued an Urgent Medical Device Recall-Lot Specific notification via e-mail/letter dated July 19, 2014, to all affected customers. The notification identified the product the problem and the action needed to be taken by the customer.
All distributors were notified via electronic mail. Hospital risk managers and surgeons, as well as distributors with affected inventory were notified via courier. Distributors were sent a letter identifying the issue and their responsibilities. These responsibilities include locating and removing the affected product in their territory as well as identifying hospitals and surgeons who have previously used the affected product. Distributors are to return on-hand affected products to Zimmer, and ensure all of their products are accounted for using the form provided in the letter. Hospital risk managers and surgeons were provided with a letter identifying the issue and their responsibilities. These responsibilities include locating the affected product, quarantining the product, and returning it to their Zimmer sales representative.
If you have questions or concerns regarding this recall please call the customer call center at 1-877-946-2761.
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.
Zimmer received a trend of complaints indicating corrosion of product.
Acción
Zimmer issued an Urgent Medical Device Recall-Lot Specific notification via e-mail/letter dated July 19, 2014, to all affected customers. The notification identified the product the problem and the action needed to be taken by the customer.
All distributors were notified via electronic mail. Hospital risk managers and surgeons, as well as distributors with affected inventory were notified via courier. Distributors were sent a letter identifying the issue and their responsibilities. These responsibilities include locating and removing the affected product in their territory as well as identifying hospitals and surgeons who have previously used the affected product. Distributors are to return on-hand affected products to Zimmer, and ensure all of their products are accounted for using the form provided in the letter. Hospital risk managers and surgeons were provided with a letter identifying the issue and their responsibilities. These responsibilities include locating the affected product, quarantining the product, and returning it to their Zimmer sales representative.
If you have questions or concerns regarding this recall please call the customer call center at 1-877-946-2761.
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
Monitor,physiological,patient(without arrhythmia detection or alarms) - Product Code MWI
Causa
The wireless function of the ip5 radio could be interrupted causing loss of wireless communication between the ip5 and host monitoring system.
Acción
The firm, Philips Healthcare, sent an "URGENT - Field Safety Notice" dated June 30, 2014 to its customers. The notice describes the product, problem and actions to be taken. The notice also provides the customers with instructions for use while waiting for the update to the IP5. A Philips representative will contact you regarding your affected device.
If you need any further information or support concerning this issue, please contact your local Philips representative: 877-468-4861 option 1, then option 2.
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
High throughput DNA sequence analyzer - Product Code PFF
Causa
A software component of the miseqdx instrument, called the illumina worklist manager
(iwm) v1.0.15, fails to perform as intended.
Acción
Illumina notified affected customers via phone, email and Product Quality Notification letter dated July 28, 2014 to describe the software anomaly. The letter identified the affected product, problem and actions to be taken. For questions contact your local support team or Illumina Technical Support at techsupport@illumina.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
Obstetrical kit - Product Code OKV
Causa
Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). this could result in an injury to the patient due to product contamination or loss of sterility condition.
Acción
Customed Inc. sent a Recall Notification letter dated June 3, 2014 via email and followed by letter to all affected customers. The letter identified the affected products, problem and actions to be taken. The letter informed customers if the affected products are in their inventory to: 1. Remove products from sale (quarantine them) and cease distribution. 2. Complete and return the enclosed acknowledgement form to Customed Inc .Recall Coordinator. Affected products should be returned to Customed Inc for credit.
Customers with questions were instructed to contact Customed Inc. Recall Coordinator at 1-787-801-0100 Ext. 7540
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
Gastroenterology-urology - Product Code FDE
Causa
Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). this could result in an injury to the patient due to product contamination or loss of sterility condition.
Acción
Customed Inc. sent a Recall Notification letter dated June 3, 2014 via email and followed by letter to all affected customers. The letter identified the affected products, problem and actions to be taken. The letter informed customers if the affected products are in their inventory to: 1. Remove products from sale (quarantine them) and cease distribution. 2. Complete and return the enclosed acknowledgement form to Customed Inc .Recall Coordinator. Affected products should be returned to Customed Inc for credit.
Customers with questions were instructed to contact Customed Inc. Recall Coordinator at 1-787-801-0100 Ext. 7540
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
Gastroenterology-urology - Product Code FHI
Causa
Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). this could result in an injury to the patient due to product contamination or loss of sterility condition.
Acción
Customed Inc. sent a Recall Notification letter dated June 3, 2014 via email and followed by letter to all affected customers. The letter identified the affected products, problem and actions to be taken. The letter informed customers if the affected products are in their inventory to: 1. Remove products from sale (quarantine them) and cease distribution. 2. Complete and return the enclosed acknowledgement form to Customed Inc .Recall Coordinator. Affected products should be returned to Customed Inc for credit.
Customers with questions were instructed to contact Customed Inc. Recall Coordinator at 1-787-801-0100 Ext. 7540
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
General surgery tray (kit) - Product Code LRO
Causa
Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). this could result in an injury to the patient due to product contamination or loss of sterility condition.
Acción
Customed Inc. sent a Recall Notification letter dated June 3, 2014 via email and followed by letter to all affected customers. The letter identified the affected products, problem and actions to be taken. The letter informed customers if the affected products are in their inventory to: 1. Remove products from sale (quarantine them) and cease distribution. 2. Complete and return the enclosed acknowledgement form to Customed Inc .Recall Coordinator. Affected products should be returned to Customed Inc for credit.
Customers with questions were instructed to contact Customed Inc. Recall Coordinator at 1-787-801-0100 Ext. 7540
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
Ring, laparotomy - Product Code FHI
Causa
Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). this could result in an injury to the patient due to product contamination or loss of sterility condition.
Acción
Customed Inc. sent a Recall Notification letter dated June 3, 2014 via email and followed by letter to all affected customers. The letter identified the affected products, problem and actions to be taken. The letter informed customers if the affected products are in their inventory to: 1. Remove products from sale (quarantine them) and cease distribution. 2. Complete and return the enclosed acknowledgement form to Customed Inc .Recall Coordinator. Affected products should be returned to Customed Inc for credit.
Customers with questions were instructed to contact Customed Inc. Recall Coordinator at 1-787-801-0100 Ext. 7540
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
General surgery tray (kit) - Product Code LRO
Causa
Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). this could result in an injury to the patient due to product contamination or loss of sterility condition.
Acción
Customed Inc. sent a Recall Notification letter dated June 3, 2014 via email and followed by letter to all affected customers. The letter identified the affected products, problem and actions to be taken. The letter informed customers if the affected products are in their inventory to: 1. Remove products from sale (quarantine them) and cease distribution. 2. Complete and return the enclosed acknowledgement form to Customed Inc .Recall Coordinator. Affected products should be returned to Customed Inc for credit.
Customers with questions were instructed to contact Customed Inc. Recall Coordinator at 1-787-801-0100 Ext. 7540
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
Prosthesis, vascular graft, of 6mm and greater diameter - Product Code DSY
Causa
The cautery that is provided with the gelweave graft in the box has a shorter shelf life indicated on its label, versus that of the graft (4 years and 5 years, respectively).
Acción
Vascutek sent an Urgent Field Safety Notice dated July 15, 2014, to all affect customers. The letter identified the product the problem and the action needed to be taken by the customer.
User Instructions:
A. Vascutek advises that you ensure suitable equipment is available prior to implantation to trim the graft if required.
B. For product received with a cautery in the interim, Vascutek request that you check the shelf life of each product before every operation. If you find that the cautery is out of date, remove and discard the cautery. If you require an appropriate cautery supplied as a separate item, please contact your local sales representative for a referral.
C.Vascutek are taking this opportunity to reinforce the cautions from the Gelweave TM Vascular Prostheses IFU regarding soaking of the graft in saline to prevent focal burning if a cautery is to be used. This statement is already included in the IFU and now appears in bold, red font to ensure appropriate awareness.
This notice needs to be passed on to all persons who need to be aware within your organization or to any organization where the devices have been transferred or distributed.
Please maintain awareness of this Field Safety Notice while all actions are taken in your organization and until these products are provided without the cautery.
Please return the User Return Slip by e-mail or fax to the Distributor's address given on page 3.
This action by Vascutek Ltd. is being taken with the knowledge of the National Competent Authority¿ Medicines and Healthcare Products Regulatory Agency (MHRA).
If you have any further questions or comments, please do not hesitate to contact us at tcvs.recall@terumomedical.com. Return Completed Form immediately fax to (734) 741-6149.
If required, your Vascutek Ltd. representative can discuss and provide more information on the use of cautery with Vascutek products. For further questions call (800) 262-3304 ext. 6056
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.
Notas adicionales en la data
Tomographic X-Ray System - Product Code lZE
Causa
Ge healthcare has become aware of a potential safety issue involving the nylon hooks which support the flashpad" detector on the discovery xr656 wall stand systems.
there have been reported incidents of detector falls, but no injuries have been reported.
Acción
Consignees were sent a GE Healthcare "Urgent Medical Device Correction" letter dated July 25, 2014. The letter was addressed to Hospital Administrators / Risk Mangers, Managers of Radiology / Cardiology and Radiologists / Cardiologists. The letter described the Safety Issue, Safety Instructions, Affected Product Details, Product Correction, and Contact Information. For questions in the USA call 800-437-1171. For other countries contact your local GE Healthcare Representative.
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
Obstetrical kit - Product Code OKV
Causa
Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). this could result in an injury to the patient due to product contamination or loss of sterility condition.
Acción
Customed Inc. sent a Recall Notification letter dated June 3, 2014 via email and followed by letter to all affected customers. The letter identified the affected products, problem and actions to be taken. The letter informed customers if the affected products are in their inventory to: 1. Remove products from sale (quarantine them) and cease distribution. 2. Complete and return the enclosed acknowledgement form to Customed Inc .Recall Coordinator. Affected products should be returned to Customed Inc for credit.
Customers with questions were instructed to contact Customed Inc. Recall Coordinator at 1-787-801-0100 Ext. 7540
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
Obstetrical kit - Product Code OKV
Causa
Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). this could result in an injury to the patient due to product contamination or loss of sterility condition.
Acción
Customed Inc. sent a Recall Notification letter dated June 3, 2014 via email and followed by letter to all affected customers. The letter identified the affected products, problem and actions to be taken. The letter informed customers if the affected products are in their inventory to: 1. Remove products from sale (quarantine them) and cease distribution. 2. Complete and return the enclosed acknowledgement form to Customed Inc .Recall Coordinator. Affected products should be returned to Customed Inc for credit.
Customers with questions were instructed to contact Customed Inc. Recall Coordinator at 1-787-801-0100 Ext. 7540