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 recalling firm notified all customers via telephone to inform them of the problem and the need to return the product when received. The recalling firm issued recall letters dated 9/17/03 to their direct accounts informing them of the problem. The also informed the account that a stop shipment had been ordered but if they receive the product they need to return it immediately.
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 recalling firm notified all customers via telephone to inform them of the problem and the need to return the product when received. The recalling firm issued recall letters dated 9/17/03 to their direct accounts informing them of the problem. The also informed the account that a stop shipment had been ordered but if they receive the product they need to return it immediately.
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.
Due to a software anomaly, an incorrect patient name may be transmitted with image to odyssey workstation.
Acción
The firm notified their affected consignees by letter on 9/15/2003. The customers were informed how to avoid the problem until a software upgrade is installed on the units.
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
Needle, Hypodermic, Single Lumen - Product Code FMI
Causa
Sterility of product is compromised by open seals in packaging.
Acción
Recall letters were sent to US customers on September 23, 2003. International customers were sent communication on September 24, 2003.
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
Calculator/Data Processing Module, For Clinical Use - Product Code JQP
Causa
Sample wheel may home to the wrong position.
Acción
Recall is accomplished by telephone and by letter. Telephone calls were made by 9/24/2003. All customers have been notified by telephone.
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.
Due to a software anomaly, an incorrect patient name may be transmitted with image to odyssey workstation.
Acción
The firm notified their affected consignees by letter on 9/15/2003. The customers were informed how to avoid the problem until a software upgrade is installed on the units.
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.
Due to a software anomaly, an incorrect patient name may be transmitted with image to odyssey workstation.
Acción
The firm notified their affected consignees by letter on 9/15/2003. The customers were informed how to avoid the problem until a software upgrade is installed on the units.
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.
EMS notified US Distributor Boston Scientific by letter dated 10/3/03 advising them to to determine the client base and provide replacement foot pedals to the final user. Boston Scientific/Microvasive notified Hospital Risk Managers by letter dated 10/6/03.Sales representatives will visit accounts to replace the foot pedal.
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.
Product may be packaged with an incorrect instructions for use (ifu) booklet.
Acción
Recall notification was sent via email to Wilson-Cook, sales representatives on 10/08/2003 for personal delivery to the affected accounts. Consignees were advised to quarantine and return all affected product via Federal Express (using Wilson-Cook Medical account) to the recalling firm. A verification form was included at the bottom portion of the notice to be returned with the affected product or faxed to Wilson-Cook. Replacement product or account credit will be provided upon receipt of any affected devices.
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
Aid, Surgical, Viscoelastic - Product Code LZP
Causa
Stability failure at the 20 month for viscosity specification.
Acción
Anika Therapeutics issued notification on 10/8/2003 by fax and FedEx to three Distributors. Distributors were requested to subrecall to their 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
Aid, Surgical, Viscoelastic - Product Code LZP
Causa
Stability failure at the 20 month for viscosity specification.
Acción
Anika Therapeutics issued notification on 10/8/2003 by fax and FedEx to three Distributors. Distributors were requested to subrecall to their 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
Aid, Surgical, Viscoelastic - Product Code LZP
Causa
Stability failure at the 20 month for viscosity specification.
Acción
Anika Therapeutics issued notification on 10/8/2003 by fax and FedEx to three Distributors. Distributors were requested to subrecall to their 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
Aid, Surgical, Viscoelastic - Product Code LZP
Causa
Stability failure at the 20 month for viscosity specification.
Acción
Anika Therapeutics issued notification on 10/8/2003 by fax and FedEx to three Distributors. Distributors were requested to subrecall to their 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
Aid, Surgical, Viscoelastic - Product Code LZP
Causa
Stability failure at the 20 month for viscosity specification.
Acción
Anika Therapeutics issued notification on 10/8/2003 by fax and FedEx to three Distributors. Distributors were requested to subrecall to their 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
Aid, Surgical, Viscoelastic - Product Code LZP
Causa
Stability failure at the 20 month for viscosity specification.
Acción
Anika Therapeutics issued notification on 10/8/2003 by fax and FedEx to three Distributors. Distributors were requested to subrecall to their 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
Indicator, Biological Sterilization Process - Product Code FRC
Causa
The 3m attest 1264/1264p biological indicators of eto sterilization contain a microbiological contaminant which can affect the performance of the positive control and the indicators to some limited extent. the color on a positive control may revert to negative after 24 hours of incubation.
Acción
The firm conducted a field correction which began on 10/24/03. They provided revised labeling for the product. Letters, dated October 24, 2003, were sent to consignees. The letters had a description of the problem, instructions for doing the relabeling in the field, and recommendations for users of the 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
Pin, Fixation, Threaded - Product Code JDW
Causa
The pin may fail because the metal used to make the pin does not meet the firm's hardness specification.
Acción
All affected U.S. accounts were sent a letter dated October 15, 2003 by certified mail, return receipt requested. The seven foreign initial consignee accounts were notified via electronic mail. Customers were asked to return non-implanted product and to advise the implanting surgeons of the problem so that they may take appropriate action in regard to their patients.
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
Unit, X-Ray, Extraoral With Timer - Product Code EHD
Causa
The cable carrier and cables may fall after repeat collisions with or lamps, radiation shields or other supported accessories.
Acción
The firm sent a letter dated, October 10, 2003 indicating the firm''s service representatives will upgrade the cable carrier by mounting a safety catch inside the cable carrier.
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
Film, Radiographic - Product Code IWZ
Causa
Loss of detail at density of 1.00 to 2.00, on certain bony structures found in original clinical films.
Acción
Recall letter sent out to direct accounts on 10/9/2003. The consignees are to review boxes and cases of emulsion film and contact the firm for a return aurthorization number.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel data.
Notas adicionales en la data
unknown device name - Product Code FFK--
Causa
The sonotrode tube could become blocked by the stone fragments, causing overheating and damage to the device.
Acción
Recalled from the hospitals by sales representative telephone calls on 10/9/03 and follow-up visits to retriev the recalled lot and replace the units with a new lot of sonotrodes.
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
Incubator, Neonatal - Product Code FMZ
Causa
Heater vent door on neonatal incubator may malfunction.
Acción
The recalling firm notified domestic consignees by certified letter and international distributors by e-mail dated 10/17/2003. The recall notice was incorporated into a firm''s follow-up letter concerning an on-going product correction of the elevating base on the same neonatal beds. The letter advises of the malfunctioning heater door vent and states that the firm will replace all existing vent doors with doors made of higher temperature rated material. Firm will provide retrofit kits for consignee or service representative installation.
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 product displays inaccurate temperature readings, patient skin burns can occur before getting to higher temperature reading.
Acción
On 10/6/03, the firm issued letters via Federal Express to all its direct consignees, informing them of the affected devices and providing instructions on the 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
Drape, Surgical - Product Code KKX
Causa
The product, labeled as sterile, had not gone through the sterilization process at the time of shipment.
Acción
Medline telephoned their sales represntatives on 10/7/03, instructing them to visit their accounts who received lot 03IA0532 and retrieve all cases of the lot distributed due to a quality issue. The accounts were informed that replacement product would be provided for the returned 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
Kit, Dna Detection, Human Papillomavirus - Product Code MAQ
Causa
Labeling error-omission of 'research use only'.
Acción
All customers are to be notified with a product correction action letter.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel data.
Notas adicionales en la data
unknown device name - Product Code IZL--
Causa
A minimum source-skin-distance of less than 30 cm and not identifying the tube manufacturer on the tube housing label resulted in the sp-hf-4.0 portable systems not complying with the u.S. federal performance standard.
Acción
An 'Important Safety Notice' dated 10/27/03 was sent to the one direct account on the same date, informing them of the non-compliances with the performance standard and requesting them to call Sedecal at 800-920-9525 to arrange for the modification of the x-ray unit at no cost to the user.