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
Test, hepatitis b (b core, be antigen, be antibody, b core igm) - Product Code LOM
Causa
Prolonged exposure of the monolisa anti-hbs eia conjugate diluent component to light may result in elevated optical densities (od) in some samples such that a negative sample could elevate to a grey zone or low positive result.
Acción
The firm, Bio-Rad Laboratories, Inc., sent an "Important Product Information Bio-Rad MONOLISA Anti-HBs EIA Catalog #25220", letter dated 27 July 2012, to their domestic consignees/customers via FedEx. The International subsidiaries will be notified by e-mail. The consignees/customers were informed of the important storage and handling information regarding the MONOLISA Anti-HBs EIA Conjugate Diluent component . The consignees/customers were instructed to follow the storage and handling instructions as stated in the Package Insert, and compare their laboratories practices to the storage and handling instructions stated by Bio-Rad.
Customers who have questions can call Bio Rad Technical Support at 1-800-224-6723, option 2, then option 3.
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
x-ray tomography, computed system - Product Code JAK
Causa
The systems all have a similar table control board. it has
been found that this board may cause the table position to be incorrect if the table cradle is moved
manually. this is referred to as "free" mode in the operation manuals. if this error does occur it is
possible that the patient could be scanned at an incorrect position.
Acción
Toshiba sent a "URGENT: MEDICAL DEVICE CORRECTION" letter to all affected customers. The letter identified the product, the problem, and the action needed to be taken by the customer.
Customers were instructed to please avoid moving the table in the "Free" or manual mode as much as possible. If it is necessary to move the table in this manner please verify the table position prior to initiating the scan sequence.
If it is noted that the position is not correct, exit the eXam plan and start a new one beginning with the scanoscopy. Please share this information with all users of the equipment and your clinical or biomedical engineering departments.
Please find the attached customer reply form. The purpose of this form is for FDA tracking. Please take a moment to complete the form and fax it to the toll free number on the form.". The contact information for this recall is:"(800) 421-1968 or contact your local Toshiba Representative at (800) 521-1968.".
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, nuclear magnetic resonance imaging - Product Code LNH
Causa
The status display in the sequence queue window may not change from "current" to "done".
Acción
A recall notification letter titled: "URGENT: MEDICAL DEVICE CORRECTION," was sent to customers. The letter stated the problem, corrective action, and (instructions) request to customers. Customers were instructed to perform the temporary recovery procedures if the problem occurs. Additionally, the acknowledgement sheet should be completed and faxed back. The information should be shared with all users, including the bio-medical or clinical engineering departments. Questions pertaining to the information for this recall were to be directed to (800) 421-1968.
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
Disinfectant, medical devices - Product Code LRJ
Causa
Metrex research is recalling cavicide containing the spring fresh fragrance because the affected lot of product containing this fragance has caused an increase in reported health reactions in some individuals such as headache, nausea, and respiratory discomfort.
Acción
Metrex sent an "URGENT: MEDICAL DEVICE RECALL" letter dated February 16, 2012 to all affected customers. The letter identifies the product, problem, and actions to be taken by the customers. A Mandatory Recall Response Form was attached for customers to complete and return via fax to 734-947-6725.
Contact Customer Care Center at (800) 841-1428 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
System, nuclear magnetic resonance imaging - Product Code LNH
Causa
Hitachi discovered a software error with a feature called multi-planar reconstruction
(mpr). mpr takes an original volume dataset reconstructed in any plane view and creates a new image set from another view (i.E. axial to coronal, coronal to sagittal, etc.). the error causes the first image in the dataset to have a right/left reversed orientation. the software error can occur randomly when execu.
Acción
Hitachi sent a Device Correction Notice letter dated June 18, 2012 to all affected customers. All letters are recorded by tracking number and date received by the consignee. The letter identified the affect product, problem and actions to be taken. All sites will be visited by Hitachi Service to install the software update to permanently resolve the issue at no cost to the facility. Software correction is targeted to start by September 1, 2012. For question contact the Manager of Regulatory Affairs at 800-800-3106 x3720
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
Pump, infusion - Product Code FRN
Causa
Should a battery with the minimum contact diameter (.51 inches) be placed on the battery spring (.53 inches), an electrical circuit will not be completed and the mini-infuser will not operate. the reason being that the mini-infuser battery spring has a flat contact that measures .53 inches ¿.01 inches on the inner diameter of the spring coil. the iec 60086-2 and ansi 08 standards specify a minimum.
Acción
Baxter sent a Safety Alert letter on January 11, 2011 for the InfusO.R. Pump. Baxter expanded the scope of the recall to include the Mini-Infusers System and sent an Urgent Device Correction letter dated March 4, 2011, via First Class mail to all affected customers. The letters informed the customers that the Mini-Infusers use the same size battery and incorporate the same battery contact interface as the InfusOR pump, and that the same feature that inhibits electrical contact in over-the counter Energizer C size batteries may also be incorporated by other battery manufacturers. The customers were requested to verify that the InfusOR and Mini-Infuser will power-on before use; if the device does not power on, replace the batteries with a different brand of size C batteries and verify that the device will power-on before use; and to place a copy of the letter with each operator's manual for the InfusOR and Mini-Infuser System for future reference. For Technical questions call Baxter Global Technical Services at 1-800-843-7867. For question regarding this communication contact the Center for One Baxter at 1-800-422-9837 during the hours of 8:00 am to 5:00 pm CST.
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
Pump, infusion - Product Code FRN
Causa
Should a battery with the minimum contact diameter (.51 inches) be placed on the battery spring (.53 inches), an electrical circuit will not be completed and the mini-infuser will not operate. the reason being that the mini-infuser battery spring has a flat contact that measures .53 inches ¿.01 inches on the inner diameter of the spring coil. the iec 60086-2 and ansi 08 standards specify a minimum.
Acción
Baxter sent a Safety Alert letter on January 11, 2011 for the InfusO.R. Pump. Baxter expanded the scope of the recall to include the Mini-Infusers System and sent an Urgent Device Correction letter dated March 4, 2011, via First Class mail to all affected customers. The letters informed the customers that the Mini-Infusers use the same size battery and incorporate the same battery contact interface as the InfusOR pump, and that the same feature that inhibits electrical contact in over-the counter Energizer C size batteries may also be incorporated by other battery manufacturers. The customers were requested to verify that the InfusOR and Mini-Infuser will power-on before use; if the device does not power on, replace the batteries with a different brand of size C batteries and verify that the device will power-on before use; and to place a copy of the letter with each operator's manual for the InfusOR and Mini-Infuser System for future reference. For Technical questions call Baxter Global Technical Services at 1-800-843-7867. For question regarding this communication contact the Center for One Baxter at 1-800-422-9837 during the hours of 8:00 am to 5:00 pm CST.
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.
This letter is to notify you that several of our sterile screw products are being voluntarily recalled. product sterility may be compromised due to a mechanical failure of the protective packaging tube. tube end plugs may dislodge creating the potential for the screw to come out of the protective tube and then the sharp end of the screw pierce the outer sterile barrier pouch.
Acción
The firm, TeDan Surgical Innovations (TSI), sent an "URGENT: Medical Device Recall" letter dated June 11, 2012 to their consignees/customers. The letter described the product, problem and actions to be taken. The customers were instructed to immediately examine their inventory and quarantine all products subject to recall and return product to TSI. In addition, if they have further distributed this product, identify all customers and notify them of this product recall at once in writing; and complete and return the enclosed Mandatory Response Form as soon as possible and no later than June 25, 2012 via mail: 12675 W. Airport Blvd., Suite 200, Sugar Land, TX 77478; fax: (713) 726-0846 or email: thernandez@tedansurgical.com.
If you have any questions, contact the Business Manager at 713-726-0886, Monday thru Friday, from 8am - 5pm or via email at THERNANDEZ@TEDANSURGICAL.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
Information released with the product agility did not originally contain information on compatibility with the add-on dynamic multileaf collimator apex.
Acción
ELEKTA sent an Important Field Safety Notice, FCO Ref: 20001405000 dated July 7, 2012, to current Agility users and a separate notice FCO Ref: 20001407026 for current Apex users who may be in the process of considering an upgrade to Agility. Both notices made it clear that Apex has not been integrated or classified as compatible for use with Agility. Users are advised not to use Apex with Agility.
For questions regarding this recall call 770-300-9725.
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
Sterilizer, chemical - Product Code MLR
Causa
Advanced sterilization products (asp) is recalling (removing) the sterrad 100s and sterrad nx system cassettes because the camera used to verify printing on the sterrad system cassettes was inadvertently disabled. the sterrad 100s and sterrad nx system cases were shipped without verification of proper printing.
Acción
Advanced Sterilization Products sent an "URGENT MEDICAL DEVICE RECALL (REMOVAL) letter dated July 16, 2012 to all their customers who purchased the STERRAD 100S and STERRAD NX System cassettes. The letter informed the customers of the problem identified and the actions to be taken. For the STERRAD NX System cassettes, there should be no impact to the functionality of these affected cassettes. Although printing may be smeared, illegible, or missing, the packaging has multiple references to the information, and the cassettes should be usable despite any printing error.
For the STERRAD 100S System cassettes, there is a chance that the barcode will be unreadable and the STERRAD 100S Sterilizer will not accept the cassette.
Customers were instructed to complete and return the business reply card and packing slip that are included in the letter. Customers were instructed to contact Stericycle at (888) 406-9303 for additional labels. Customers with questions about the recall letter were instructed to contact Stericycle at (888) 406-9303.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notas adicionales en la data
Sterilizer, chemical - Product Code MLR
Causa
Advanced sterilization products (asp) is recalling (removing) the sterrad 100s and sterrad nx system cassettes because the camera used to verify printing on the sterrad system cassettes was inadvertently disabled. the sterrad 100s and sterrad nx system cases were shipped without verification of proper printing.
Acción
Advanced Sterilization Products sent an "URGENT MEDICAL DEVICE RECALL (REMOVAL) letter dated July 16, 2012 to all their customers who purchased the STERRAD 100S and STERRAD NX System cassettes. The letter informed the customers of the problem identified and the actions to be taken. For the STERRAD NX System cassettes, there should be no impact to the functionality of these affected cassettes. Although printing may be smeared, illegible, or missing, the packaging has multiple references to the information, and the cassettes should be usable despite any printing error.
For the STERRAD 100S System cassettes, there is a chance that the barcode will be unreadable and the STERRAD 100S Sterilizer will not accept the cassette.
Customers were instructed to complete and return the business reply card and packing slip that are included in the letter. Customers were instructed to contact Stericycle at (888) 406-9303 for additional labels. Customers with questions about the recall letter were instructed to contact Stericycle at (888) 406-9303.
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, nuclear magnetic resonance imaging - Product Code LNH
Causa
The firm recalled due to a potentail problem with the position of the hold in the lug teminals on the power cables connected to the terminal blocks on the gradient coil.
Acción
Toshiba America Medical Systems, Inc, sent a Urgent Medical Device Correction letter dated February 21, 2012, via USPS return receipt mail to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer.
Customers were instructed if you subsequently find that images are abnormally noisy compared to images acquired under the same conditions in the system before this modification was performed, contact your Toshiba Service Representative.
Please share this information with all users and reviewing radiologist as well as clinical engineering or biomedical group at your facility.
Please complete and return the attached form and fax it to the toll free number at the top of the form. This form can also be sent via email toraffairs@tams.com.
Contact information was also provided (800) 421-1968 or contact your local Toshiba Representative at (800) 521-1968.
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.
Unit fails to power up, resulting in an equipment alarm.
Acción
The firm, Zoe Medical, coordinated with the Distributor via email on June 7, 2012. The email described the product, problem and actions to be taken. Zoe will remove product the site and return the units for correction.
If you have any questions, contact Manager, Global Technical Support at 425-657-7200 ext 5508.
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
Spinal vertebral body replacement device - Product Code MQP
Causa
The firm voluntarily recalled the device after they discovered that the sterilization recommendations on the product insert did not pass sterilization validation.
Acción
Lucero Medical sent a Field Correction Notice letter dated July 15, 2012 to it's sole consignee. The notice identified the affected product., problem and actions to be taken. The customer was instructed to complete the response card and submit back to their local Lucero Medical 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.
Johnson & johnson healthcare products (jjhp) is voluntarily recalling this product to address fda concerns that the product should have been cleared under a separate medical device application. this voluntary recall is not being conducted on the basis of any consumer safety or product performance issues related to k-y liquibeads. jjhp received a warning letter on may 23, 2012 indicating that thi.
Acción
Johnson & Johnson sent Recall Letters/Response forms dated June 29, 2012 on July 2, 2012. The recall notification included affected lots and instructions for wholesale distributors and retailers that handle the product. The recalled product is being handled by Stericycle. The notification included phone and fax numbers in the event assistance is required. Customers were asked to complete the enclosed business Reply Form and return immediately; identify all warehouse/wholesale inventories of products and return immediately per the attached "Return Authorization Form." For any questions regarding the form, customers were asked to call Stericycle at 888-406-9309. Customers could also fax questions to 877-877-0318. Once customers have collected all returns, they should send back immediately per the enclosed instructions.
For questions regarding this recall call 908-874-1000.
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, mobile - Product Code IZL
Causa
Software issue: a violation of 21 cfr 1020.31(a). after an image is taken, when the user selects and clears an additionally displayed screen the system inhibit is also cleared, allowing the user to take an exposure without the technique factors being displayed.
Acción
The firm will issue Important Electronic Product Radiation Warning letters that identify the affected product along with a description of the defect and related hazards. Users are instructed to ensure that the acquisition mode is always selected prior to attempting an exposure to confirm the techniques selected. The firm will remedy the issue or bring the device into compliance free of charge. A GE Healthcare Service Representative will update the software on the system to address the issue.
Field Modification Instructions (FMI) 10865(2) describes the rework plan the GEHC Engineers will make to the imaging system to return it to compliance with the applicable performance standard. It appears to adequately address the problem and is hereby approved.
Users are to contact 800-437-1171 in the US, if they have any questions or concerns.
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, mobile - Product Code IZL
Causa
Software issue: a violation of 21 cfr 1020.31(a). after an image is taken, when the user selects and clears an additionally displayed screen the system inhibit is also cleared, allowing the user to take an exposure without the technique factors being displayed.
Acción
The firm will issue Important Electronic Product Radiation Warning letters that identify the affected product along with a description of the defect and related hazards. Users are instructed to ensure that the acquisition mode is always selected prior to attempting an exposure to confirm the techniques selected. The firm will remedy the issue or bring the device into compliance free of charge. A GE Healthcare Service Representative will update the software on the system to address the issue.
Field Modification Instructions (FMI) 10865(2) describes the rework plan the GEHC Engineers will make to the imaging system to return it to compliance with the applicable performance standard. It appears to adequately address the problem and is hereby approved.
Users are to contact 800-437-1171 in the US, if they have any questions or concerns.
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
Coil, magnetic resonance, specialty - Product Code MOS
Causa
On july 27, 2012, it was reported to the firm that the siemens 3t 15ch knee coil was not functional because the coil identification code for the device was incorrect.
Acción
Since all of the devices were located at various Siemens distribution locations, all communications were internal to Siemens concerning bringing the coils from one warehouse to another.
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 placement guidewire diameter is too large and does not pass-through the introducer needle during the placement procedure of the peg feeding tube.
Acción
Kimberly-Clark Health Care sent an Urgent Voluntary Medical Device Withdrawal letter dated June 22, 2010, to all affected customers. The letter included a Product Withdrawal Response Sheet which was to be returned to Kimberly-Clark.
The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to quarantine and destroy all affected products and complete the attached Product Withdrawal Response Sheet and Fax the form to 920-225-4182.
For questions customers should call 770-587-7362.
For questions regarding this recall call 770-587-8393.
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.
It has come to firm's attention that, in some rare cases, the blood outlet connector on some models of maquet oxygenators may detach from the oxygenator. this event has occurred in about 0.01% (1:10,000) of units shipped.
Acción
Maquet sent a Field Safety Notices and Confirmation Forms dated June 13, 2012 to all affected customers. A Follow-up communication dated July 20, 2012 was mailed to all affected US customers. The Field Safety Notice identifies the problem, affected product, risk factors and actions to be taken by the customer. Customers were instructed to complete the Confirmation form and return in the self-addressed prepaid envelop. For questions call 201-995-8968.
Maquet issued an updated Field Safety Notice/Field Safety Notice Confirmation Form dated 2/14/13 via Fed Ex on 2/18/2013.
Maquet sent out an Updated Field Safety Notice/field Safety Notice Confirmation Form dated 4/4/2013 in order to notify customers they would be providing safety clamps.
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 firm decided to recall when an issue was found with the dose calculation in raystation 2.5, raystation 2.5.1. the problem has not caused any patient mistreatment or other incidents. however, the user must be aware of this information to avoid incorrect dose calculations during treatment planning. the dose calculation is not correctly normalized in the unusual case of preventing the optimizatio.
Acción
The firm, RaySearch Laboratories, sent an "Urgent Field Safety Notice, Medical Device Correction" letter dated May 9, 2012 to its customers. The letter describes the product, problem and actions to be taken. The letter informed the customers that the "workaround is to not use segment MU optimization" and that there "is in general no need to manually adjust the segment shapes to such an extent there is need for a separate optimization of the segment MU." Additionally, the customers were instructed -Do not uncheck the "Segment shapes" check box; educate planning staff and all users about this workaround; inspect your product and identify all installed units with the noted software version numbers; and complete and return the Reply Form via fax to: RaySearch Americas Inc. at 888-501-7195; email: freddie.cardel@raysearchlabs.com and/or email to: Raysearch Laboratories AB at niclas.borglund@raysearchlabs.com.
For further information and return of the Reply Form contact For the Americas: Director of Customer Support, RaySearch Americas at +1877 778 3849 or freddie.cardel@raysearchlabs.com; and For Europe, Asia and rest of the world: Director of Service, RaySearch Laboratories AB at +46 8 5450 6130 or niclas.borglund@raysearchlabs.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
Catheter and tip, suction - Product Code JOL
Causa
Invuity is notifying customers to return all obsolete britefield illuminated suction devices from the field. it has not been distributed since march 2011 as the next generation product was introduced at that time.
Acción
Invuity sent E-mails to those locations thought to still be in possession of the old model of the device in July 2012. Distributors had been e-mailed in May 2012 to make sure that they had returned any of the device that was in stock.
For questions regarding this recall call 415-655-2100.
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, laryngeal (taub) - Product Code EWL
Causa
Helix medical llc is recalling the blom-singer indwelling tep occluder due to an invalid expiration date.
Acción
A recall letter dated March 8, 2012, was sent to customers who purchased the Blom-Singer Rapid Response Voice Prosthesis TEP Occluder 4mm 20Fr. (IN2004-TO). The letter informed the customers of the problem identified and the action to be taken. Customers were instructed to contact Customer Service Center at (800) 477-5969 if they have products to be returned. Customers were instructed to return Blom-Singer Rapid Response Voice Prosthesis TEP Occluder 4mm 20Fr. (IN2004-TO) to:
Helix Medical, LLC
Attn to: Customer Service-IN2004-TO.
1110 Mark Avenue
Carpinteria, CA 93013
For questions regarding this recall call 805-684-3304.
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.
On 1/20/2011 cordis corporation , miami lakes, fl initiated a recall of their sleek otw pta dilatation catheter model #4261201x lot #50027149 and model #4261501x lot #50026688. product is incorrectly labeled.
Acción
Cordis (Johnson & Johnson Company) sent an Urgent Medical Device Field Corrective Action Notice dated January 31, 2011, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to review, sign, and return the enclosed Acknowledgment Form directly to Cordis at the fax number on the form, or to their local sales representative. Pass the revised labeling notice to all who need to be aware within their facility or organization. Also, customers were asked to maintain awareness of this notice until all affected product in their facility has been consumed. In addition to their local Cordis representative, they may contact the normal HCS Customer Service number at 1-800-327-7714, option 1, option 3.
For questions regarding this recall call 786-313-2365.