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.
Accuro has received reports of some apex pumps either failing to operate or malfunctioning, at times without notifying the user of such failure or malfunction on the unit's display screen.
Acción
The firm, Accuro, sent an "Urgent: Medical Device Recall" letter dated August 30, 2012 to the customers via e-mail on August 31, 2012. The letter describes the product, problem and actions to be taken. The customers were instructed to remove all devices from use immediately; to immediately complete and return the enclosed Accuro response form via email to; (customer.service@accuromedical.com) or fax to: (1-800-866-0545) . Note: the form still needs to be returned even if you no longer have or use the device. Upon receipt, Customer Service will call the account with instructions to arrange for all devices to be returned to Accuro.
General questions were directed to Customer Service at 1-800-669-4757.
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
Instrument, biopsy - Product Code KNW
Causa
Sterility of the product may be compromised.
Acción
The firm, Remington Medical, Inc., sent an "URGENT - MEDICAL DEVICE RECALL" letter dated August 29, 2012 to its customers. The letter described the product, problem and actions to be taken. The customers were instructed to immediately examine their inventory and quarantine the products; complete and return the FaxBack form via Fax to: Quality Engineer Remington Medical, Inc., at 770-887-0732 or email: tracyw@remmed.com; and call the Quality Engineer or customer service at (800) 989-0057 ext 233 to obtain a RGA number and have a call tag issued.
Should you have any questions, please do not hesitate to call the Quality Engineer at (800) 989-0057 ext 233.
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
Screwdriver - Product Code HXX
Causa
Field complaints indicate that recent shipments of the 14-400795 and 36505 drivers do not properly mate
("lock") into some of the specified screw heads. drivers near mmc (maximum material condition) or that are misshapen may not properly mate with screws at mmc. design dimensions and tolerances of the drivers are not properly specified to prevent an incorrect fit between the drivers and the screw.
Acción
Biomet sent an "URGENT MEDICAL DEVICE RECALL NOTICE'' dated August 23, 2012 to all affected customers. The letter identified the product, problem, and the actions to be taken by the customers. A Fax Back Response Form was included for customers to complete and return via fax to 574-372-1683. Contact the firm at 574-372-1570 for questions related to 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
Screwdriver - Product Code HXX
Causa
Field complaints indicate that recent shipments of the 14-400795 and 36505 drivers do not properly mate
("lock") into some of the specified screw heads. drivers near mmc (maximum material condition) or that are misshapen may not properly mate with screws at mmc. design dimensions and tolerances of the drivers are not properly specified to prevent an incorrect fit between the drivers and the screw.
Acción
Biomet sent an "URGENT MEDICAL DEVICE RECALL NOTICE'' dated August 23, 2012 to all affected customers. The letter identified the product, problem, and the actions to be taken by the customers. A Fax Back Response Form was included for customers to complete and return via fax to 574-372-1683. Contact the firm at 574-372-1570 for questions related to 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
Intervertebral fusion device with bone graft, lumbar - Product Code MAX
Causa
When using the optional s-lift (also known as s-lif) implant guides without stops, there is a known risk of moving the implant guides, and possibly the implant, too far into the disc space creating the potential for injury to the patient. the instructions for use for the s-lift implant guides will be amended to add the following warning: "care is to be taken to not over insert the implant guides.
Acción
Spine Frontier issued a Correction Notice Letter August 22, 2012 to all affected customers to update the Instructions for Use. The letter identified the affected product, problem and actions to be taken. Customers were Instructed to remove the Instructions for Use they currently have and replace them with the update. The letter instructs customers to complete and return the Response Form to 978-232-3990.
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.
ICU Medical, Inc. acquired from Pfizer in early 2017, Hospira Infusion Systems, the portion of Hospira dedicated to develop infusion pumps.
Notas adicionales en la data
Container, i.V. - Product Code KPE
Causa
Embedded iron oxide glass defect which may have the potential to break off into the solution.
Acción
Hospira sent an "URGENT DEVICE RECALL" dated August 28, 2012 to all affected customers. The letter identified the product, problem,and actions to be taken by the customers. The letter included an Urgent Device Recall Reply Form for customers to complete and return via fax to 1-888-237-5582. Contact Hospira Customer Care at 1-877-946-7747 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.
Notas adicionales en la data
Intraoperative orthopedic joint assessment aid - Product Code ONN
Causa
Ortho sensor in sunrise, fl is recalling the graphics user interface software 1.8 (which was updated to version 1.82, validated on 02/13/12). recall was initiated due to customer feedback which included the line of site between the knee ba lancer and the link station was obstructed by or metal stands or trays or the knee balancer device was placed atop of or near the metal stands or trays, interru.
Acción
Orthosensor did not provide a written customer notification. As the recall was reported to the FDA well after all nine of the products were corrected (the recall stemmed from an initial inspection of the firm), then no customer notification was requested.
The removal and replacement of the previous version of the Graphic User Interface Software is being handled internally by members of Operations and the Sales force. The items the firm is recalling is software, and the software cannot be returned; the old version (version 1.8) would be erased. The new version 1.82 would be installed and downloaded into the equipment at the site during servicing.
This does not involve the customer of which none are consignees. Effectiveness checks associated with the update of the software is being handled internally by the Operations and the Sales force.
Further questions please call (813) 645-2855.
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 "retaining washers & clevis pins" provided with the ac -powered adjustable hospital beds may fail under certain circumstances. the pins at the top of the leg were disengaging from the channel. this may cause the bed frame to come off tracks or collapse.
Acción
The firm, Primus Medical LLC, sent an "Important Notification Relating to Primus Medical Product TL500" letter dated March 29, 2011 to their customers. The letter described the product, problem and actions to be taken. The customers were instructed to replace the "Retaining washers & Clevis Pins" with the "Clevis Pins & Bow Tie Cotter Pins" in the TL500-001 Service Pack provided with the letter in order to avoid any potential failure and/or bed collapse and to return the" Retaining washers & Clevis Pins" after the replacement procedure is performed.
If you have any questions, or need assistance in performing the replacement, call 330-965-9681.
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
Chair, with casters - Product Code INM
Causa
Winco mfg., llc in ocala, fl is recalling the caremor cliner model numbers 5351 and 5361. the recall was initiated due to a report that a back frame did not "snap" onto a chair frame properly.
Acción
Winco notified consignees via phone except for the one located in Saudi Arabia, who was contacted by e-mail. All consignees have been sent a follow-up e-mail. The notification identified the product, the problem, and the action to be taken to be taken by the customer. Customers should remove the chair from use and the upholstered back will not be required to be returned. Winco will send out new fully assembled upholstered backs.
For questions customers should call 352-854-2929, ext 123.
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
Chair, with casters - Product Code INM
Causa
Winco mfg., llc in ocala, fl is recalling the caremor cliner model numbers 5351 and 5361. the recall was initiated due to a report that a back frame did not "snap" onto a chair frame properly.
Acción
Winco notified consignees via phone except for the one located in Saudi Arabia, who was contacted by e-mail. All consignees have been sent a follow-up e-mail. The notification identified the product, the problem, and the action to be taken to be taken by the customer. Customers should remove the chair from use and the upholstered back will not be required to be returned. Winco will send out new fully assembled upholstered backs.
For questions customers should call 352-854-2929, ext 123.
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 anspach effort, inc. in palm beach gardens, fl is recalling the foot control/foot pedal due to the foot control cable lacking the shield connection from the cable to the connector body.
Acción
Anspach sent an Urgent Product Removal letter dated January 9, 2012 to all affected customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to contact their sales representative to facilitate the removal action by providing a replacement for the affected product. For question contact your local sales representative or the Product Support department.
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.
Modular necks were manufactured out of specification by a vendor; the taper provide is undersized.
Acción
Smith & Nephew sent an "URGENT:CLASS II RECALL-HIGH OFFSET MODULAR NECK R1213 letter dated August 22, 2012 to all affected customers. The letter identified the product, problem, and the actions to be taken by the customers. Customers were instructed to cease use and distribution of the product and quarantine for return. An Inventory Return Certification Form was included for customers to complete and return via fax to 901-566-7975.
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
Colorimetry, acetaminophen - Product Code LDP
Causa
Alere san diego is recalling alere triage tox drug screen because there is a possibility that after installing the code chip provided with the affected lots: amp, bar, and pcp, the threshold ranges may not be consistently set correctly in all meters.
Acción
Alere sent a 'NOTICE OF CORRECTION" letter dated July 12, 2012 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. Customers with questions were instructed to contact Technical Services at (877) 308-8287. Customers were instructed to complete the Customer/Distributor Verification Form Notice of Correction even if they do not have any involved product and fax back to Technical Services at (858) 805-8457 or scan and email to responses.ts@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.
Abbott vascular is recalling the armada 35 and armada 35 ll pta catheters because they have discovered that some devices may exhibit difficulty inflating and/or deflating.
Acción
An "Urgent Device Recall" letter dated 8/20/2012 was sent to all customers who purchased the Armada 35 and Armada 35 LL PTA Catheters. The letter informed the customers of the problem identified and the action to be taken. A list of lot numbers and an effectiveness check form was sent to customers with the customer notification letter. Customers were instructed to call Abbott Vascular Customer Service at (800) 227-9902.
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
Mixture, hematology quality control - Product Code JPK
Causa
Clinical diagnostic solutions, inc. in plantation, fl recalled boule con diff us tri pack (product part 501-605, lot #1102-575 and 1102-576; product part 501-607, lot #1102-576; and product part 502-012, lot #1102-574) which is used for in vitro diagnostic use as a control to monitor the performance of multi-parameter hematology instruments. the recall was initiated due to the receipt of a complai.
Acción
Clinical Diagnostic Solutions, Inc. sent a letter dated March 24, 2011, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. The firm istructed the accounts to replace the assay sheet they were currently using with the new assay sheets enclosed. For an unused product they would need to discard. To correct the ranges in their instrument, they would need to scan in the new bar codes specific for their instrument type. For any questions customers were instructed to contact CDE Technical Support atl 800-453-3328.
For questions regarding this recall call 954-791-1773.
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 pre-vacuum steam sterilization (wrapped method) temperature in the instructions for use incorrectly listed 121-123¿c , instead of the correct 132-133¿c.
Acción
Stryker sent "Urgent Device Correction" letters dated March 27, 2013 to all affected customers. The letter identified the product, problem, 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
Mixture, hematology quality control - Product Code JPK
Causa
Clinical diagnostic solutions, inc. in plantation, fl recalled boule con diff us tri pack (product part 501-605, lot #1102-575 and 1102-576; product part 501-607, lot #1102-576; and product part 502-012, lot #1102-574) which is used for in vitro diagnostic use as a control to monitor the performance of multi-parameter hematology instruments. the recall was initiated due to the receipt of a complai.
Acción
Clinical Diagnostic Solutions, Inc. sent a letter dated March 24, 2011, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. The firm istructed the accounts to replace the assay sheet they were currently using with the new assay sheets enclosed. For an unused product they would need to discard. To correct the ranges in their instrument, they would need to scan in the new bar codes specific for their instrument type. For any questions customers were instructed to contact CDE Technical Support atl 800-453-3328.
For questions regarding this recall call 954-791-1773.
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
Mixture, hematology quality control - Product Code JPK
Causa
Clinical diagnostic solutions, inc. in plantation, fl recalled boule con diff us tri pack (product part 501-605, lot #1102-575 and 1102-576; product part 501-607, lot #1102-576; and product part 502-012, lot #1102-574) which is used for in vitro diagnostic use as a control to monitor the performance of multi-parameter hematology instruments. the recall was initiated due to the receipt of a complai.
Acción
Clinical Diagnostic Solutions, Inc. sent a letter dated March 24, 2011, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. The firm istructed the accounts to replace the assay sheet they were currently using with the new assay sheets enclosed. For an unused product they would need to discard. To correct the ranges in their instrument, they would need to scan in the new bar codes specific for their instrument type. For any questions customers were instructed to contact CDE Technical Support atl 800-453-3328.
For questions regarding this recall call 954-791-1773.
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.
Vascular solutions, inc., became aware of a potential problem involving pouches missing a seal from guardian ii (model 8210) and guardian ii nc (model fh102) hemostasis valve which poses a risk of product contamination.
Acción
The firm, Vascular Solutions, sent an "URGENT - Medical Device Field Safety Notice" dated August 24, 2012 and a follow-up "Urgent Medical Device Removal - Lot Specific" letter dated August 30, 2012 to its customers. The letter described the product, problem and actions to be taken. The customers were instructed to immediately check their inventory and to follow steps outlined in the letter which included to complete and return the "VSI Account Inventory Form" via email to: customerservice@vasc.com or fax: to (763) 656-4251.
If you have specific questions or concerns regarding this matter, please contact your local Vascular Solutions Account Manager; call (763) 656 4300 or email: Senior Regulatory Operations Associate at SOuellette@vasc.com and/or email: www.vascularsolutions.com.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
The display on the system has the potential to change. in house testing eventually identified the unique sequence of events that must occur in order for this issue to manifest itself.
Acción
Volcano Corporation sent an "IMPORTANT FIELD CORRECTIVE ACTION" letter dated August 24, 2012 to all affected customers. The letter identifies the product, problem, and actions to be taken by the customers. Contact your local Volcano sales representative or Volcano Customer Service 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.
Oscor, inc. in palm harbor, fl is recalling myocardial heart wires, models tme60s, tme64s, tme64c, tme64s-3, tme65s, and tme66s. the recall was initiated due to the spacing between anchoring zig-zag to electrode is out of specification.
Acción
Oscor sent a customer notification letter dated July 25, 2012, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to send the listed models and lots in their inventory back to the recalling firm for immediate replacement. They were also instructed to call Oscor Customer Service at 727-937-2511 to obtain a Return Goods Product (RGA) number.
For questions regarding this recall call 727-937-2511, ext. 133.
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
Catheter, irrigation - Product Code GBX
Causa
Conmed linvatec recalled their 24k arthroscopy outflow/suction tubing set (product number 24k100)because there is a possibility that the product may have a breach in the tyvek seal that could potentially compromise the sterility of the contents.
Acción
ConMed Linvatec sent a Urgent Medical Device Recall Notification via FedEx to all affected customers. This notice should be received July 5, 2011. The letter identified the product the problem and the action needed to be taken by the customer.
All returned product under this removal action will be identified, segregated, and quarantined per ConMed Utica, N.Y. procedures. Returned product will be dispositioned in accordance with ConMed Utica, N.Y. procedures. This can include repackaged and resterilization with new lot number or product scrap. ConMed Utica, N.Y. will maintain control of all individual lot numbers returned and dispositioned.
Firm is striving for 1005 effectiveness. If a Reply form is not received within approximately 30 days of the first mailing, ConMed Linvatec will make two additional contacts by mail approximately 30-35 days apart.
Should you have any additional questions please contact our Customer Service at 800-237-0169 or fax at 727-319-5701.
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.
As part of st. jude medical's routine tracking and product monitoring, they have received a total of 214 reports, out of 34,617 eon mini ipgs, that lost the ability to communicate or recharge due to an inner battery weld issue resulting in loss of pain relief and subsequent explant. explant surgery, as with any surgery, presents a risk to patient health. adverse events associated with an unplanne.
Acción
St. Jude Medical sent a Important Medical Device Recall Advisory dated July 26, 2012, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer.
To further assist in your patient care we are providing you with a list of all serial numbers we show have been distributed to you. ( See Attachment A ).
Further questions please call (972) 309-2154.
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.
St. jude medical has informed your doctor that a number of cases have been reported in which discomfort associated with heating occurred at the device site while patients were using the charging system to charge their spinal cord stimulator. in three cases, patients received a burn to the skin (one second-degree and two first-degree burns) at the implant site. as of june 30, 2012, st. jude medica.
Acción
ST. Jude Medical sent an Important Medical Device Safety Information dated July 26, 2012 to affected customers. The letter identifed the affected product, problem and actions to be taken. For questions or concerns contact your ST. Jude Medical representative or St. Jude Medical Neuromodulation Division at 1-866-240-6741.