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
Condom - Product Code HIS
Causa
The condoms are being recalled because information recently available indicates some of these condoms do not meet airburst test standards.
Acción
Recall letters dated 11/25/02 were issued to direct accounts via U.S. Mail, asking wholesalers to stop distribution of the lot, return stocks on hand, and conduct a recall to the retail level.
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
Condom With Nonoxynol-9 - Product Code LTZ
Causa
The condoms are being recalled because information recently available indicates some of these condoms do not meet airburst test standards.
Acción
Recall letters dated 11/25/02 were issued to direct accounts via U.S. Mail, asking wholesalers to stop distribution of the lot, return stocks on hand, and conduct a recall to the retail level.
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 79F
Causa
A gap in the exterior seal may lead to sterility concerns with the interior pouch.
Acción
The sites and/or distributors that received suspect devices were contacted by telephone on 12/11/02 and given instructions on how to return/replace the devices. In addition, a letter dated 12/11/02 was sent 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.
Notas adicionales en la data
Instrument, Manual, General Obstetric-Gynecologic - Product Code KOH
Causa
May have incorrectly printed graduation markings along the tube shaft.
Acción
A recall letter dated February 20, 2003 was issued to each customer. Customers were instructed to cease use of the lot and to return the product to Portex.
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.
Possible electrical shock hazard, as the power cord grounding pin may break off or become detached.
Acción
Letters dated April 24, 2003 were sent to each consignee instructing them to inspect the beds for power cords with non-flared ground pins, to cut plug off any such cords when found, and replace these plugs with new plugs with the flared ground pin. [The type of plug on the unit can be seen by the naked eye, as the plug is transparent plastic molding.]
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.
Possible electrical shock hazard, as the power cord grounding pin may break off or become detached.
Acción
Letters dated April 24, 2003 were sent to each consignee instructing them to inspect the beds for power cords with non-flared ground pins, to cut plug off any such cords when found, and replace these plugs with new plugs with the flared ground pin. [The type of plug on the unit can be seen by the naked eye, as the plug is transparent plastic molding.]
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, Monitoring, Perinatal - Product Code HGM
Causa
The 2120 main board on device lacks required external safety 'watchdog' circuit.
Acción
The firm mailed or faxed a recall letter to consignees on May 14, 2003 followed by a phone call to each account within two weeks to arrange for a service technician visit to correct the monitors. The recall letter warned the hospitals of the problem and a work around.
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
Source, Chemiluminescent Light - Product Code MPU
Causa
Lights split, spilling contents when bent to activate.
Acción
Users are instructed to cease use and return the product immediately in a letter issued 8/7/2003 return receipt requested.
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
Paper, Obstetric Ph - Product Code LNW
Causa
Lactate disposable membrane caps linearity was determined to be significantly biased and could potentially cause erroneous patient results above 6.0 mmol/l.
Acción
Instrumentation Laboratories notified two (2) U.S. direct customers on August 28, 2003 by telephone, regarding Lot N30601. Follow-up phoning emphasizing significance of linearity problem (and additional involved lot N307 - for 1 affected customer) performed on September 3, 2003. Phone call followed with faxback acknowledging notification and disposition of remaining product lot(s). IL service also dispatched to customer sites on September 4, 2003.
International Distributor Notices sent to IL Europe and IL Mexico on September 4, 2003. Product Information Bulletins circulated on September 3, 2003, to IL personnel worldwide.
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
Laparoscope, Gynecologic (And Accessories) - Product Code HET
Causa
A defective articulation band may result in improper staple formation with possible hematosis.
Acción
The firm contacted their customers by FedEx on 11/25/2003. The product will be returned and destroyed.
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
Laparoscope, Gynecologic (And Accessories) - Product Code HET
Causa
A defective articulation band may result in improper staple formation with possible hematosis.
Acción
The firm contacted their customers by FedEx on 11/25/2003. The product will be returned and destroyed.
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
Laparoscope, Gynecologic (And Accessories) - Product Code HET
Causa
A defective articulation band may result in improper staple formation with possible hematosis.
Acción
The firm contacted their customers by FedEx on 11/25/2003. The product will be returned and destroyed.
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.
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
Extractor, Vacuum, Fetal - Product Code HDB
Causa
Product is mislabeled as a mushroom cap vacuum but actually contains a bell style assisted delivery system.
Acción
CooperSurgical telephoned consignees on 8/18/04 and sales representatives to visit the account for removal of recalled 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
Monitor, Cardiac, Fetal - Product Code KXN
Causa
Inadequate trocar tip assembly that might yeild parts to patients.
Acción
Initiated recall by letter on 9/16/2004 via Fedex/UPS. Follow-up to nonresponders in 30 days.
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
Hysteroscope (And Accessories) - Product Code HIH
Causa
Deformation of the verspoint hysteroscopic system connector cable hand grips when autoclaved causing possible non-sterile electrodes.
Acción
The recall letter was mailed to the Director of Material Management and the Director of Operating Room on December 14, 2004.
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, Monitoring, Perinatal - Product Code HGM
Causa
A deficiency in the software code can, in certain circumstances, cause data for the wrong patient to be displayed in the tracing review screen when a user is acknowledging an alert.
Acción
Consignees were first notified by telephone on 01/11/2005. A brief document was sent via email or fax on/about 01/13/2005.
Canadian data is current through March 2018. All of the data comes from Health Canada, 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 Canada.
Notas adicionales en la data
Causa
Problem dans l'affichage des traces d'une patiente lors d'une situation d'alerte dans certaines conditions.
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
Clamp, Circumcision - Product Code HFX
Causa
Not labeled as reprocessed, when this lot has been reprocessed.
Acción
Consignees were notified to return the product via letter dated 4/12/05.
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
Clamp, Circumcision - Product Code HFX
Causa
Lot 11224 may contain a 1.1 cm clamp and bell and neither lot is labeled as reprocessed, when they have been reprocessed.
Acción
Consignees were notified to return the product via letter dated 4/12/05.
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 hysteroscope adapter used with the hta system may disassemble and result in a fluid leak.
Acción
Boston Scientifc notified accounts by letter dated June 28, 2005 via Federal Express. Accounts are requested to check invnetory and return. Any adapters out of box have no lot identification and can be tested per instructions
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, Monitoring, Perinatal - Product Code HGM
Causa
Unit may not power up due to faulty circuit board.
Acción
Analogic notified customers by letter dated 9/13/05. Distributors were requested to notify their accounts and return units for replacement of the main circuit board.