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
Assay, glycosylated hemoglobin - Product Code LCP
Causa
Kits contain recalled triad alcohol pads.
Acción
Heritage Labs sent a Device Notification and Safety Alert letter dated January 12, 2011, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Heritage Labs sent replacement alcohol prep pads from a different supplier not affected by the recall to user of Heritage Labs kits. Heritage Labs recommended the replacements be on "as needed" basis.
Upon opening kit, users should immediately dispose of sealed TRIAD brand alcohol pads.
Users are to use the replacement wipes instead of the wipes contained in the kits.
For any questions call (888)764-4120.
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
Assay, glycosylated hemoglobin - Product Code LCP
Causa
Kits contain recalled triad alcohol pads.
Acción
Heritage Labs sent a Device Notification and Safety Alert letter dated January 12, 2011, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Heritage Labs sent replacement alcohol prep pads from a different supplier not affected by the recall to user of Heritage Labs kits. Heritage Labs recommended the replacements be on "as needed" basis.
Upon opening kit, users should immediately dispose of sealed TRIAD brand alcohol pads.
Users are to use the replacement wipes instead of the wipes contained in the kits.
For any questions call (888)764-4120.
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
Assay, glycosylated hemoglobin - Product Code LCP
Causa
Kits contain recalled triad alcohol pads.
Acción
Heritage Labs sent a Device Notification and Safety Alert letter dated January 12, 2011, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Heritage Labs sent replacement alcohol prep pads from a different supplier not affected by the recall to user of Heritage Labs kits. Heritage Labs recommended the replacements be on "as needed" basis.
Upon opening kit, users should immediately dispose of sealed TRIAD brand alcohol pads.
Users are to use the replacement wipes instead of the wipes contained in the kits.
For any questions call (888)764-4120.
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
Causa
Products shipped to us locations that do not have approved applications for pma , ide or 510(k) clearance.
Acción
Urgent Device Recall notification letters were sent to all US consignees on March 4, 2014 by e-mail and US mail as well as a phone call. The letter identified the products and actions to be taken by the customers.
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
Dilator, vessel, of percutaneous catherization - Product Code DRE
Causa
Boston scientific is initiating a medical device recall removal regarding nine lots/batches of super sheath and super sheath r/o introducer sheaths. boston scientific was informed through product complaints that the 0.035" id dilator may be labeled incorrectly as a 0.038" id dilator.
Acción
Boston Scientific sent an URGENT MEDICAL DEVICE RECALL REMOVAL -IMMEDIATE ACTION REQUIRED letter dated November 21, 2011. The letter described the product and the problem. Customers were instructed to segregate the affected product immediately and return it to Boston Scientific. Distributors were advised that the recall removal depth is to the hospital level and the recall removal notification should be forwarded to their customers.
For questions regarding this recall call 763-494-1133.
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
Assay, glycosylated hemoglobin - Product Code LCP
Causa
Kits contain recalled triad alcohol pads.
Acción
Heritage Labs sent a Device Notification and Safety Alert letter dated January 12, 2011, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Heritage Labs sent replacement alcohol prep pads from a different supplier not affected by the recall to user of Heritage Labs kits. Heritage Labs recommended the replacements be on "as needed" basis.
Upon opening kit, users should immediately dispose of sealed TRIAD brand alcohol pads.
Users are to use the replacement wipes instead of the wipes contained in the kits.
For any questions call (888)764-4120.
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
Assay, glycosylated hemoglobin - Product Code LCP
Causa
Kits contain recalled triad alcohol pads.
Acción
Heritage Labs sent a Device Notification and Safety Alert letter dated January 12, 2011, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Heritage Labs sent replacement alcohol prep pads from a different supplier not affected by the recall to user of Heritage Labs kits. Heritage Labs recommended the replacements be on "as needed" basis.
Upon opening kit, users should immediately dispose of sealed TRIAD brand alcohol pads.
Users are to use the replacement wipes instead of the wipes contained in the kits.
For any questions call (888)764-4120.
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
Assay, glycosylated hemoglobin - Product Code LCP
Causa
Kits contain recalled triad alcohol pads.
Acción
Heritage Labs sent a Device Notification and Safety Alert letter dated January 12, 2011, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Heritage Labs sent replacement alcohol prep pads from a different supplier not affected by the recall to user of Heritage Labs kits. Heritage Labs recommended the replacements be on "as needed" basis.
Upon opening kit, users should immediately dispose of sealed TRIAD brand alcohol pads.
Users are to use the replacement wipes instead of the wipes contained in the kits.
For any questions call (888)764-4120.
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
Assay, glycosylated hemoglobin - Product Code LCP
Causa
Kits contain recalled triad alcohol pads.
Acción
Heritage Labs sent a Device Notification and Safety Alert letter dated January 12, 2011, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Heritage Labs sent replacement alcohol prep pads from a different supplier not affected by the recall to user of Heritage Labs kits. Heritage Labs recommended the replacements be on "as needed" basis.
Upon opening kit, users should immediately dispose of sealed TRIAD brand alcohol pads.
Users are to use the replacement wipes instead of the wipes contained in the kits.
For any questions call (888)764-4120.
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
Bolts holding the trim weight may break causing the plates of the counterweight to become loose and fall into the cover.
Acción
Siemens sent a Customer Information Letter on December 1, 2011 to all affected customers. The letter idenfied what is the issue, when does the issue occur and what Siemens will do to address the issue. The letter recommend that the Customer Information letter be included in the Linear Accelerator System Owner manual chapter Safety Advisory Letters.
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
Assay, glycosylated hemoglobin - Product Code LCP
Causa
Kits contain recalled triad alcohol pads.
Acción
Heritage Labs sent a Device Notification and Safety Alert letter dated January 12, 2011, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Heritage Labs sent replacement alcohol prep pads from a different supplier not affected by the recall to user of Heritage Labs kits. Heritage Labs recommended the replacements be on "as needed" basis.
Upon opening kit, users should immediately dispose of sealed TRIAD brand alcohol pads.
Users are to use the replacement wipes instead of the wipes contained in the kits.
For any questions call (888)764-4120.
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
Assay, glycosylated hemoglobin - Product Code LCP
Causa
Kits contain recalled triad alcohol pads.
Acción
Heritage Labs sent a Device Notification and Safety Alert letter dated January 12, 2011, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Heritage Labs sent replacement alcohol prep pads from a different supplier not affected by the recall to user of Heritage Labs kits. Heritage Labs recommended the replacements be on "as needed" basis.
Upon opening kit, users should immediately dispose of sealed TRIAD brand alcohol pads.
Users are to use the replacement wipes instead of the wipes contained in the kits.
For any questions call (888)764-4120.
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
Assay, glycosylated hemoglobin - Product Code LCP
Causa
Kits contain recalled triad alcohol pads.
Acción
Heritage Labs sent a Device Notification and Safety Alert letter dated January 12, 2011, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Heritage Labs sent replacement alcohol prep pads from a different supplier not affected by the recall to user of Heritage Labs kits. Heritage Labs recommended the replacements be on "as needed" basis.
Upon opening kit, users should immediately dispose of sealed TRIAD brand alcohol pads.
Users are to use the replacement wipes instead of the wipes contained in the kits.
For any questions call (888)764-4120.
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.
Heritage Labs sent a Device Notification and Safety Alert letter dated January 12, 2011, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Heritage Labs sent replacement alcohol prep pads from a different supplier not affected by the recall to user of Heritage Labs kits. Heritage Labs recommended the replacements be on "as needed" basis.
Upon opening kit, users should immediately dispose of sealed TRIAD brand alcohol pads.
Users are to use the replacement wipes instead of the wipes contained in the kits.
For any questions call (888)764-4120.
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
Assay, glycosylated hemoglobin - Product Code LCP
Causa
Kits contain recalled triad alcohol pads.
Acción
Heritage Labs sent a Device Notification and Safety Alert letter dated January 12, 2011, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Heritage Labs sent replacement alcohol prep pads from a different supplier not affected by the recall to user of Heritage Labs kits. Heritage Labs recommended the replacements be on "as needed" basis.
Upon opening kit, users should immediately dispose of sealed TRIAD brand alcohol pads.
Users are to use the replacement wipes instead of the wipes contained in the kits.
For any questions call (888)764-4120.
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
Dressing, wound,drug - Product Code FRO
Causa
Unapproved drug claims and those not approved under 510k clearance.
Acción
Oculus Innovative Sciences sent an"URGENT MEDICAL DEVICE RECALL" letter dated November 15, 2011 to all affected customers. The letter describes the product, problem, and the actions to be taken by the customers. The letter instructs customers to identify and remove all affected product from inventory. A Business Reply Card was attached to the letter for customers to complete and return via fax to 1-415-462-5181. Call Oculus Innovative Sciences Customer Service at 1-800-759-9305 for questions regarding this recall.
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.
Ethox tum-e-vac gastric lavage kit #2075, lot number 031123255 was labeled with expiration date symbol and date of 2010/10 on the unit product label. the carton was labeled with a manufacturing date symbol and date of 2010/10. the ethox tum-e-vac gastric lavage kit #2075 does not have an expiration date.
Acción
Ethox International, Inc. sent an "URGENT DEVICE RECALL" letter dated March 25, 2011 to all affected customers. The letter describes the product, problem, and the actions to be taken by the customers. The letter instructs customers to
examine their stock immediately to determine if they have the affected product. Customers are to return the affected product to the firm by using UPS account 128959. Customers will be reimbursed for the returned goods. Additionally, a response form was enclosed for customers to complete and return. Contact the firm at (716) 842-4000 for questions regarding this recall.
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.
Manufacturing issue: the distal tip of the outer sheath (return electrode) may detach and become loose in the joint during use.
Acción
Smith & Nephew Inc. Endoscopy Division notified facilities on 11/7/11 via an "Urgent - Product Recall 1st Notification - Urgent" letter and/or phone. The letter identified the affected product and the reason for the recall. It also discussed the potential risks, customer actions, and instructions for the return of the product. Customers were to check their inventory and locate any of the affected product. They were to also complete the requested contact information and return the notification letter. In addition, customers were to contact Smith & Nephew Endoscopy Division Returns Group at endo.andreturns@smith-nephew.com for information on how to return the affected product and receive replacement product. Questions, contact Hoangthi Le directly by phone at 508-337-3731.
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, stationary - Product Code KPR
Causa
Ge healthcare has become aware of a potential issue associated with the patient barrier rotating arm that is a part of the definium 8000 and discovery xr650 image pasting systems that may impact patient and user safety.
the patient barrier rotating arms that are used to position and stabilize the patient during image pasting procedures may fail to retain residual friction at the arm pivot. thi.
Acción
The firm, GE Healthcare, sent an "URGENT MEDICAL DEVICE CORRECTION" letter dated November 17, 2011 to its customers. The letter described the Safety Issue, Safety Instructions, Affected Product Details, Product Correction and Contact Information. The customers were instructed to ensure that all potential users in their facility are made aware of this safety notification and the recommended actions; discontinue use of the patient barrier and remove from service (away from patients) if either one the rotating arm locking levers is damaged (does not hold the rotating arm in place when engaged); take extra precautions to hold the patients barrier rotating arm during release of the locking lever and repositioning of the arm and store the rotating arms in the lowest pivot position (down) when not in use. The letter also stated that the patient barrier may continue to be used if the rotating arm locking lever securely holds the rotating arm in place when it is engaged.
Additionally, GE Healthcare will modify the rotating arms to restore the residual friction so that the arm will retain position (rather than swing freely) while the locking levers are disengaged. Also, GE will update the product labeling to improve awareness and identify the hazard relative to proper storage.
If you have any questions, call Center in US: 800-437-1171; Japan: 0120-055-919 and for other countries, please contact your local GE Healthcare Service Representative if you have any questions or concerns regarding this notification.
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
Absorber, carbon-dioxide - Product Code BSF
Causa
Intersurgical incorporated has issued a voluntary recall of the is cans carbon dioxide absorber due to a possibility that loose granules may enter the inspiratory path of the breathing system.
Acción
Intersurgical Inc. sent an "URGENT MEDICAL DEVICE RECALL" letter dated February 8, 2011 to all affected customers. The letter described the product, problem, and actions to be taken by the customers. The letter instructs customers to immediately discontinue use and quarantine any affected product found. A Recall Response Form was attached to the letter for customers to complete and return via fax at 315-451-3696, Attn: Customer Service. Contact Customer Service at 1-800-828-9633 if you have questions concerning this recall.
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
Tampon, menstrual, unscented - Product Code HEB
Causa
A limited number of kotex natural balance security unscented tampons, regular absorbency, are being recalled after a raw material contaminated with a bacterium, enterobacter sakazakii, was found when testing the plunger portion of the applicator.
Acción
Kimberly-Clark sent an Urgent Product Recall letter, dated 11/09/2011, via FedEx to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to identify, quarantine, and discontinue use immediately. Customers were asked to complete the response form and fax to +1 (920) 380-6467. A Kimberly-Clark representative would contact them regarding return of the product, replenishement and/or account credit.
For questions regarding this recall call +1 (920) 216-8152.
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
Causa
Products shipped to us locations that do not have approved applications for pma , ide or 510(k) clearance.
Acción
Urgent Device Recall notification letters were sent to all US consignees on March 4, 2014 by e-mail and US mail as well as a phone call. The letter identified the products and actions to be taken by the customers.
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
in vitro diagnostic - Product Code CHH
Causa
Alere has identified that a bias on results for certain analytes tested on the alere cholestech ldx system may exist due to humidity variability.
Acción
Alere sent an Updated Urgent Recall Notification Letter in March 2012 to all their customers who are in possession of one or more Cholestech LDX Systems. The updated letter provides the customers with important information about the problem identified and the actions to be taken. Customers are instructed to operate their device in a controlled environment that maintains humidity within 40-60% relative humidity if the device has not been upgraded with ROM pack v3.40. If humidity cannot be monitored, the device is no longer CLIA waived. Customers are instructed to complete the customer verification form. A previous notice from Alere sent in November 2010 instructs users to contact Alere to receive the ROM pack upgrade. Customers may email LDXROM@alere.com to request an electronic form to complete and return via email. Customers can expect their ROM packs approximately 10 to 14 business days after Alere receives their request. If customers have transferred ownership to another party, they can email Alere at LDXROM@alere.com with the updated contact information. If customers are not currently using their Cholestech LDX System, it is recommended that the ROM Pack upgrade be installed prior to restarting use of any Cholestech LDX analyzer. Customers with questions regarding this communication can call Alere at (877) 441-7440, option 1 or email at LDXROM@alere.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.
Cordis corporation is issuing a correction for their super torque mb angiographic catheter after receiving a report of marker bands dislodged during a procedure. model numbers 532598a, 532598b, 532598c, 532598d, srd5724mb and srd5727mb are affected by the cordis correction.
Acción
Cordis Corporation sent a Correction letter dated November 21, 2011 to all affected customers. The letter describes the product, problem, and actions to be taken by the customers. Customers are instructed to read the "Description" and "Recommendations" sections, sign and return an enclosed Acknowledgement Form, and to maintain awareness of the communication until the information has been incorporated into the Cordis Super Torque MB Catheter labeling. Contact Cordis at 800-781-0282 for questions regarding this notice.
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.
Cordis corporation is issuing a correction for their super torque mb angiographic catheter after receiving a report of marker bands dislodged during a procedure. model numbers 532598a, 532598b, 532598c, 532598d, srd5724mb and srd5727mb are affected by the cordis correction.
Acción
Cordis Corporation sent a Correction letter dated November 21, 2011 to all affected customers. The letter describes the product, problem, and actions to be taken by the customers. Customers are instructed to read the "Description" and "Recommendations" sections, sign and return an enclosed Acknowledgement Form, and to maintain awareness of the communication until the information has been incorporated into the Cordis Super Torque MB Catheter labeling. Contact Cordis at 800-781-0282 for questions regarding this notice.