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
Assay,Hybridization And/Or Nucleic Acid Amplification For Detection Of Hepatitis C Rna,Hepatitis C Virus - Product Code MZP
Causa
An increased frequency of 'blue foci' that potentially can cause elevated a450 background in microwell plate wells after the addition of conjugate reagent during pcr detection.
Acción
With respect to U.S distribution, email/letter on 6/24/04 to the local safety officers and general managers stationed at the affiliated distribution center, Roche Diagnostics Corporation of Indianapolis, IN.
With respect to overseas distributors, email/letter on 6/24/04 to the local safety officers and general managers stationed at the affiliated distribution centers. Roche stated that the local safety officer is responsible to communicate the advisory both to the customers/end-users and the regulatory authority of the country.
On July 6, 2004, a Revised Important Product Advice Notice was sent out to affiliates requiring the immediate discontinuation of the use of the affected kits, and destruction of any kits remaining in customers hands.
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
Causa
An increased frequency of 'blue foci' that potentially can cause elevated a450 background in microwell plate wells after the addition of conjugate reagent during pcr detection.
Acción
With respect to U.S distribution, email/letter on 6/24/04 to the local safety officers and general managers stationed at the affiliated distribution center, Roche Diagnostics Corporation of Indianapolis, IN.
With respect to overseas distributors, email/letter on 6/24/04 to the local safety officers and general managers stationed at the affiliated distribution centers. Roche stated that the local safety officer is responsible to communicate the advisory both to the customers/end-users and the regulatory authority of the country.
On July 6, 2004, a Revised Important Product Advice Notice was sent out to affiliates requiring the immediate discontinuation of the use of the affected kits, and destruction of any kits remaining in customers hands.
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
Anesthesia Conduction Kit - Product Code CAZ
Causa
Trays contain hospira recalled 2ml drug ampuls of 5% lidocaine hydrochloride with 7.5% dextrose injection, (ndc 0074-4712-01, lot number 09-568-dk)
hospira, inc. was recalling the 2ml drug vials of 5% lidocaine hydrochloride w/ 7.5% dextrose lot number 09-568-dk). the drug is being recalled due to reports of particulate in the product.
Acción
Smiths Medical notifed Dealers and direct customers were contacted via letter delivered by Federal Express on July 2, 2004. Customers and dealers are directed to fax back the attached Reply 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 was added by ICIJ.
The parent company information is based on 2017 public records.
Notas adicionales en la data
Fibrin Split Products - Product Code GHH
Causa
Defective reagent may cause in vitro diagnostic test kit to yield false positive test results in clinical samples.
Acción
The recalling firm notified consignees on 7/1/04 by letter flagged as a customer notification. The notice describes the potential for invalid control results using the speckled cards. The letter requests users to return the cards for replacement. Defective cards are described as isolated to those packaged in heat sealed cellophane type bags. The firm requests customers to return a response form with quantity needed for replacement.
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, Percutaneous - Product Code DQY
Causa
The product is labeled as straight catheter but the package contains contralateral guide shaped catheters.
Acción
A recall letter dated 04/30/2004 was sent to the consignees, instructing them to discontinue using the product and informed them that a Cordis representive would remove any unit in their possesion.
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, Mammographic - Product Code IZH
Causa
X-ray tube actuator shaft may fail, allowing the mechanism to drop without warning.
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 tip of the staple remover may puncture a hole in the wall of the tray, compromising the sterility of the kit.
Acción
Recall notifications were sent by fax and follow-up registered mail to the direct account distributors and users on 7/12-15/04. The accounts were informed of the potential non-sterility of the product and were instructed to immediately discontinue sale/use of the products and place all inventory in quarantine pending return to Medikmark. Distributors were instructed to sub-recall the kits from their customers. Any questions were directed to 1-847-596-7723.
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 tip of the staple remover may puncture a hole in the wall of the tray, compromising the sterility of the kit.
Acción
Recall notifications were sent by fax and follow-up registered mail to the direct account distributors and users on 7/12-15/04. The accounts were informed of the potential non-sterility of the product and were instructed to immediately discontinue sale/use of the products and place all inventory in quarantine pending return to Medikmark. Distributors were instructed to sub-recall the kits from their customers. Any questions were directed to 1-847-596-7723.
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 tip of the staple remover may puncture a hole in the wall of the tray, compromising the sterility of the kit.
Acción
Recall notifications were sent by fax and follow-up registered mail to the direct account distributors and users on 7/12-15/04. The accounts were informed of the potential non-sterility of the product and were instructed to immediately discontinue sale/use of the products and place all inventory in quarantine pending return to Medikmark. Distributors were instructed to sub-recall the kits from their customers. Any questions were directed to 1-847-596-7723.
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
Stent, Coronary - Product Code MAF
Causa
Due to characteristics in the delivery catheters that have the potential to impede balloon deflation during a coronary angioplasty procedure.
Acción
Press release has been issued. Institutions with affected units will receive packages outlining the recall process and should immediately discontinue use of these units. Clinician and patient inquiries may be directed to Boston Scientific.
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.
Sheep blood products may be contaminated with a brucella species (b. ovis).
Acción
Distributors were notified by fax, all customers were notified by fax with a UPS overnight delivery of hard copy of recall letter to same customers. BD International was notified be e-mail.
Distributor fax indicated that BD required their customer lists immediately due to the nature of the recall event. BD received all Distributor customer lists on the same day (7/2/04).
Will monitor the number of consignees non-responding to the recall through sending a letter that contains a form that we ask the end-user to return.
Response forms will be reconciled.
Distribution of the affected lots ceased on 7/1/04.
Customers are asked to discard 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.
Sheep blood products may be contaminated with a brucella species (b. ovis).
Acción
Distributors were notified by fax, all customers were notified by fax with a UPS overnight delivery of hard copy of recall letter to same customers. BD International was notified be e-mail.
Distributor fax indicated that BD required their customer lists immediately due to the nature of the recall event. BD received all Distributor customer lists on the same day (7/2/04).
Will monitor the number of consignees non-responding to the recall through sending a letter that contains a form that we ask the end-user to return.
Response forms will be reconciled.
Distribution of the affected lots ceased on 7/1/04.
Customers are asked to discard 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.
Sheep blood products may be contaminated with a brucella species (b. ovis).
Acción
Distributors were notified by fax, all customers were notified by fax with a UPS overnight delivery of hard copy of recall letter to same customers. BD International was notified be e-mail.
Distributor fax indicated that BD required their customer lists immediately due to the nature of the recall event. BD received all Distributor customer lists on the same day (7/2/04).
Will monitor the number of consignees non-responding to the recall through sending a letter that contains a form that we ask the end-user to return.
Response forms will be reconciled.
Distribution of the affected lots ceased on 7/1/04.
Customers are asked to discard 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.
Sheep blood products may be contaminated with a brucella species (b. ovis).
Acción
Distributors were notified by fax, all customers were notified by fax with a UPS overnight delivery of hard copy of recall letter to same customers. BD International was notified be e-mail.
Distributor fax indicated that BD required their customer lists immediately due to the nature of the recall event. BD received all Distributor customer lists on the same day (7/2/04).
Will monitor the number of consignees non-responding to the recall through sending a letter that contains a form that we ask the end-user to return.
Response forms will be reconciled.
Distribution of the affected lots ceased on 7/1/04.
Customers are asked to discard 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.
Sheep blood products may be contaminated with a brucella species (b. ovis).
Acción
Distributors were notified by fax, all customers were notified by fax with a UPS overnight delivery of hard copy of recall letter to same customers. BD International was notified be e-mail.
Distributor fax indicated that BD required their customer lists immediately due to the nature of the recall event. BD received all Distributor customer lists on the same day (7/2/04).
Will monitor the number of consignees non-responding to the recall through sending a letter that contains a form that we ask the end-user to return.
Response forms will be reconciled.
Distribution of the affected lots ceased on 7/1/04.
Customers are asked to discard 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
Test, Thrombin Time - Product Code GJA
Causa
Complaints were received from the field regarding prolonged clot times, high control values and erratic results.
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.
Sheep blood products may be contaminated with a brucella species (b. ovis).
Acción
Distributors were notified by fax, all customers were notified by fax with a UPS overnight delivery of hard copy of recall letter to same customers. BD International was notified be e-mail.
Distributor fax indicated that BD required their customer lists immediately due to the nature of the recall event. BD received all Distributor customer lists on the same day (7/2/04).
Will monitor the number of consignees non-responding to the recall through sending a letter that contains a form that we ask the end-user to return.
Response forms will be reconciled.
Distribution of the affected lots ceased on 7/1/04.
Customers are asked to discard 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.
Sheep blood products may be contaminated with a brucella species (b. ovis).
Acción
Distributors were notified by fax, all customers were notified by fax with a UPS overnight delivery of hard copy of recall letter to same customers. BD International was notified be e-mail.
Distributor fax indicated that BD required their customer lists immediately due to the nature of the recall event. BD received all Distributor customer lists on the same day (7/2/04).
Will monitor the number of consignees non-responding to the recall through sending a letter that contains a form that we ask the end-user to return.
Response forms will be reconciled.
Distribution of the affected lots ceased on 7/1/04.
Customers are asked to discard 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.
Sheep blood products may be contaminated with a brucella species (b. ovis).
Acción
Distributors were notified by fax, all customers were notified by fax with a UPS overnight delivery of hard copy of recall letter to same customers. BD International was notified be e-mail.
Distributor fax indicated that BD required their customer lists immediately due to the nature of the recall event. BD received all Distributor customer lists on the same day (7/2/04).
Will monitor the number of consignees non-responding to the recall through sending a letter that contains a form that we ask the end-user to return.
Response forms will be reconciled.
Distribution of the affected lots ceased on 7/1/04.
Customers are asked to discard 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.
Process change in the manufacturing of the ac/dc driver board used on the analyzer may result in one or more of the solid state relays to fail during use.
Acción
The firm initiated the recall by Technical Service Bulletin sent to affected customers. The AC/DC boards will be replaced on each analyzer by a firm 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.
Sheep blood products may be contaminated with a brucella species (b. ovis).
Acción
Distributors were notified by fax, all customers were notified by fax with a UPS overnight delivery of hard copy of recall letter to same customers. BD International was notified be e-mail.
Distributor fax indicated that BD required their customer lists immediately due to the nature of the recall event. BD received all Distributor customer lists on the same day (7/2/04).
Will monitor the number of consignees non-responding to the recall through sending a letter that contains a form that we ask the end-user to return.
Response forms will be reconciled.
Distribution of the affected lots ceased on 7/1/04.
Customers are asked to discard 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 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 ---
Causa
Device component can become disconnected or dislodged, leading to ineffective ventilation, which could result in serious injury or death.
Acción
On 7/8/04, the firm initiated the recall. ***[After CDRH recommendations for class I recall situation, the firm issued PR via AP on 8/6/04.]***
.
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.
Sheep blood products may be contaminated with a brucella species (b. ovis).
Acción
Distributors were notified by fax, all customers were notified by fax with a UPS overnight delivery of hard copy of recall letter to same customers. BD International was notified be e-mail.
Distributor fax indicated that BD required their customer lists immediately due to the nature of the recall event. BD received all Distributor customer lists on the same day (7/2/04).
Will monitor the number of consignees non-responding to the recall through sending a letter that contains a form that we ask the end-user to return.
Response forms will be reconciled.
Distribution of the affected lots ceased on 7/1/04.
Customers are asked to discard 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.
Neuro adapter may fail to engage and adequately clamp to the surgical table, resulting in movement.
Acción
Allen Medical notified the two distributors by telephone on 7/12/04 and 7/16/04. A customer notifcation letter issued requesting return of the device for 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.
Generator failure resulting increase of catheter temperature that could not be controlled by power reduction.
Acción
Customers were instructed to suspend use of the generators with software version 1.033 until they are upgraded with version 1.034B in a letter dated 7/15/2004. Firm issued a second letter on 9/17/04 for a software error discovered in-house during the upgrade. It instructs a workaround solution to prevent unwanted activity of the catheter.