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
surgical table patient support - Product Code FWZ
Causa
Material used to manufacture accessory bracket does not meet product specification. the screw is normally composed of ''torlon'', which is yellow. the part was made of "tercite", which is blue.
Acción
A notification letter was sent to all 8 consignees on 02/16/2007. The firm will send service representatives to review any devices on site and replace with the proper part if needed.
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
cataract surgical instrument - Product Code KYG
Causa
Mislabeled: carton label incorrectly labeled as ref 581618 (.40 x 16mm) , may contain product ref 581617 (.50 x 16mm).
Acción
BD Opthalmic notifiied accounts by telephone on 3/2/07 and followed with letter. Accounts are requested to return product.
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
Blood Glucose monitoring system. Individual test meter and test strip kit. - Product Code NBW
Causa
The front button covers may detach from the meter.
Acción
The firm intends to send letters to all customers that have registered their units under the firm's warranty database and the firm's first consignees. In addition, this notification will be placed on the company website, with e-mail and phone contacts as needed. Letter dated March 5, 2007.
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
PET/CT computed tomography system - Product Code KPS
Causa
A potential anomaly was identified on the ct subsytem, which could result in the radiation dose being different than the calculated dose reported to the operator.
Acción
The customers were sent Public Safety Notification November 3, 2006, indicating there was a problem with the software. However, since their unit was recently upgraded the problem did not impact their unit.
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.
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
Troponin-I Reagent - Product Code MMI
Causa
False negative results : the analytical sensitivity claim of less than or equal to 0.01 ng/ml (ug/l) might not be met for all lots of architect stat troponin-i reagents, thus false negative results may occur with negative results less than 0.1 ng/ml.
Acción
Abbott sent a Product Correction letter on 3/8/07 to all Troponin-I customers who received reagent lots in the last 12 months. The letters informed the accounts that the analytical sensitivity claim of
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
Suture Passer - Product Code NBW
Causa
Product is labeled as reusable but there is a potential that the cannulated handle of the product cannot be
cleaned adequately following use.
Acción
Smith & Nephew notified accounts by letter on 3/1/07, users are advised to destroy product and return unused product in their inventory. A reply form is required to be completed.
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
Suture Passer - Product Code NBW
Causa
Product is labeled as reusable but there is a potential that the cannulated handle of the product cannot be
cleaned adequately following use.
Acción
Smith & Nephew notified accounts by letter on 3/1/07, users are advised to destroy product and return unused product in their inventory. A reply form is required to be completed.
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
Suture - Product Code NBW
Causa
Product is labeled as reusable but there is a potential that the cannulated handle of the product cannot be
cleaned adequately following use.
Acción
Smith & Nephew notified accounts by letter on 3/1/07, users are advised to destroy product and return unused product in their inventory. A reply form is required to be completed.
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
Drug Metabolizing Enzyme Genotyping System - Product Code NTI
Causa
The current package insert for the amplichip cyp 450 test, lists an incorrect part number for dnase i. the dnase is listed in the "other materials required" section as 'dnase i rec., rnase-free, p/n 04716728001 (roche applied science)" . the part number listed for the dnase i listed is incorrect and of lower specific activity than the correct/validated dnase.
Acción
A product advisory notice was issued on March 9, 2007 to all affiliates, indentifying the problem and listing corrective actions followed by a customer letter (Urgent Medical Device Correction) issued on 3/21/2007, requesting several actions be performed including discontinued use of incorrect DNAse I.
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
Drug Metabolizing Enzyme Genotyping System - Product Code NTI
Causa
The current package insert for the amplichip cyp 450 test, lists an incorrect part number for dnase i. the dnase is listed in the "other materials required" section as 'dnase i rec., rnase-free, p/n 04716728001 (roche applied science)" . the part number listed for the dnase i listed is incorrect and of lower specific activity than the correct/validated dnase.
Acción
A product advisory notice was issued on March 9, 2007 to all affiliates, indentifying the problem and listing corrective actions followed by a customer letter (Urgent Medical Device Correction) issued on 3/21/2007, requesting several actions be performed including discontinued use of incorrect DNAse I.
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
Pacemakers - Product Code NVZ
Causa
Pacing rate; software anomaly affecting vitatron dual chamber c-series and t-series pacemakers, related to automatic retrograde conduction testing, can inhibit the device from pacing if the patient's intrinsic rate falls below the programmed lower rate.
Acción
Advisory letters to physicians were mailed in February 2007. Sales respresentatives will follow-up with physicians by visit. A programmer software update will be released upon regulatory approval. The Advisory Letter provided short-term direction to reduce problems pending software upgrades.
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
Infusion Pump - Product Code FRN
Causa
Software anomaly that causes the pump to experience a sudden and unexpected failure. this anomaly occurs during the pump's startup sequence when the pump's preventative maintenance alarm goes off, preventing the pump from completing its power up routine. lock-up occurs and the pump will not function.
Acción
Consignees were initially notified of the recall via a Customer Information Bulletin which was sent via electronic mail 2/3/07 and confimed with a telephone conversation. A Product Recall Notification and a Product Recall Bulletin will be sent to all consignees via the mail on 2/16/07.
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
Laryngoscope Kit - Product Code CCW
Causa
The mri battery is out of specification for its magnetic content.
Acción
Teleflex telephoned the account on 3/1/07, and faxed them a follow-up recall letter on the same date. The account was informed that the batteries did not meet specification, and was requested to check the batteries in the laryngoscope kit shipped to them for the affected battery lot numbers, and return the affected batteries to Teleflex for replacement. Any questions were directed to Linda Todd at 1-800-334-9751, ext. 4951.
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
Vein Holder - Product Code KDC
Causa
Incorrectly assembled by manufacturer.
Acción
The consignees were notified of the product recall by letter dated February 19, 2007. Consignees were asked to return product to the manufacturer and replacement product is being offered.
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
Wound Cleanser - Product Code KMF
Causa
Coloplast corp. is recalling sea-clens brands sea-clens wound cleaner which were found to have some particulates (foreign materials).
Acción
The initial consignees of the product were contacted and notified of the recall February 14, 2007. The consignees were asked to contact their customers immediately and return all product to the manufacturer.
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
Pacemakers - Product Code NVZ
Causa
Pacing rate: software anomaly affecting vitatron dual chamber c-series and t-series pacemakers, related to automatic retrograde conduction testing, can inhibit the device from pacing if the patient's intrinsic rate falls below the programmed lower rate.
Acción
Advisory letters to physicians were mailed in February 2007. Sales respresentatives will follow-up with physicians by visit. A programmer software update will be released upon regulatory approval. The Advisory Letter provided short-term direction to reduce problems pending software upgrades.
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
syringe - Product Code FMF
Causa
The unit label on a limited number of syringes is incorrect, citing a 20 ml size. all other levels of labeling are correct, identifying the product as 30 ml size.
Acción
Distributors were sent recall notification letters on February 1, 2007
Recall notification letters were sent to all direct accounts and potential end users via UPS second day air on February 15, 2007.
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
Digoxin Reagent - Product Code KXT
Causa
The lower detection limit (ldl) may be a higher value than stated in the labeling. note: to resolve this issue, the digoxin ldl claim has been revised to 0.3 ng/ml for all reagent lots.
Acción
A recall letter dated 3/16/07 was sent to each consignee advising them that the LDL claim in the label has been revised to 0.3 ng/ml for all reagent lots.
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
Biopsy Needle - Product Code KNW
Causa
Pouches were not sealed prior to sterilization.
Acción
Consignees were contacted by telephone on 01/19/2007. Each customer was informed the sterility of the product may be compromised as a result of unsealed pouches and requested to visually check their inventory.
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
PLASMA, COAGULATION CONTROL , TEST STRIPS - Product Code GJS
Causa
The product was erroneously distributed to home users in contrast to its use for healthcare professionals only.
Acción
All consignees were notified by telephone on/or about 2/28/07 and some received a follow-up letter dated 3/2/07 or 3/5/07.
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
Excimer Laser System - Product Code LZS
Causa
Observed 'central islands' in patients following custom myopia laser procedures using the ladar6000 excimer laser. (on may 11, 2007, alcon notified consignees that the device software programs for customcornea myopia and customcornea myopia with astigmatism of the device would be deactivated).
Acción
Consignees were notified of the recall via two letters. On Feb. 21, 2007, consignees were requested to immediately stop performing all custom cornea myopia procedures and to return an acknowledgement card indicating they have received the alert and understand the required actions. On May 11, 2007, Alcon notified consignees that the device software programs for CustomCornea Myopia and CustomCornea Myopia with Astigmatism of the device would be deactivated. After meeting with CDRH's Office of Compliance on August 27, 2007, the recalling firm committed to total product removal of the device. Notification will begin in Sept 2007 and will be made by personal visits to each consignee.
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.
Assay failure: assay failures may occur due to the kit control running outside of the established range (invalidating the assay).
Acción
The consignees & distributors were notified by letter on 2/15/07 . The Distributors are instructed to forward the notification to the customers who have received the affected products. A response form will be requested from 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
Ventilator - Product Code CBK
Causa
In rare instances, the safety valve may remain open after an occlusion is resolved. if the safety valve does not reset, the ventilator will detect a circuit disconnect condition. when this happens, the ventilator will annunciate a high-urgency audible alarm and the ventilator will not resume normal operation.
Acción
The correction will extend to the end user. All users will be contacted by mail or through personal contact. In the U.S., all customers were mailed the 'Urgent Device Correction' letter along with a serial number listing of those units which records show were consigned to them beginning on March 12, 2007.
The customer communication informs customers of the issue and provides instruction for continued safe use of the device pending the correction.
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
Penile Prosthesis Tip Extenders - Product Code FAE
Causa
Mis-labeling: the dura-ii 2 cm universal tips and the dura-ii 4 cm distal tips were incorrectly labeled with the opposite labels.
Acción
The consignees were notified of the recall by letter starting Feb 7, 2007. Consignees were asked to return product to American Medical Systems.