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
bone screw - Product Code HWC
Causa
Lack of assurance of sterility, as the sterile barrier packaging may have been compromised.
Acción
Hospital accounts were notified via recall letter dated 6/26/06 and distributor accounts were notified via recall letter dated 6/28/06 to return the product. Recall was extended to additional lots via recall letter dated 7/26/06.
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
bone screw - Product Code HWC
Causa
Lack of assurance of sterility, as the sterile barrier packaging may have been compromised.
Acción
Hospital accounts were notified via recall letter dated 6/26/06 and distributor accounts were notified via recall letter dated 6/28/06 to return the product. Recall was extended to additional lots via recall letter dated 7/26/06.
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
bone screw - Product Code HWC
Causa
Lack of assurance of sterility, as the sterile barrier packaging may have been compromised.
Acción
Hospital accounts were notified via recall letter dated 6/26/06 and distributor accounts were notified via recall letter dated 6/28/06 to return the product. Recall was extended to additional lots via recall letter dated 7/26/06.
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
Telemetry System - Product Code MHX
Causa
System warning alarm failure: when a patient being monitored is in a pre-existing condition of continuous message or advisory level alarm preceding a system warning level alarm, the system warning audible alarm and flashing yellow border around the patient panel at the cic does not occur.
Acción
An Urgent Medical Device Correction letter, dated June 23, 2006, was sent to customers notifying them of the issue, provided short term recommendations and provided the long term solution as a software upgrade that will correct this situation. A reply card is asked to be returned to initiate the upgrade process.
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
guide catheter delivery sheath - Product Code DQY
Causa
Enpath has become aware that some of the enpath medical 8f & 9f steerable sheath devices may have a non-conforming flushport bond that causes a leak where air may enter the flush port chamber.
Acción
Enpath''s three Distributors were notified via letter or telephone on June 27th, 29th and July 6th with a description of the problem and further distribution or use of any remaining product should cease immediately. Instructed to notify their customers about the product and forward to Enpath for evaluation.
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
ligament staple impactor - Product Code HXJ
Causa
The impactors are being recalled for modification so that they can be disassembled fully for cleaning and sterilization, on suspicion that the assembled items retain contamination after cleaning and may not be effectively sterilized by the recommended hospital sterilization cycles.
Acción
Customer recall notifications included:
a) Telephone notification to highest volume users
b) Recall letters were sent via certified mail to all customers June 1, 2006.
Customers were instructed to cease using immediately and return the Impactors to Tapco. The customers were instructed to call the firm for a return authorization number. Modified loaner Impactors will be made available to customers as soon as possible.
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
Alcohol - ethyl alcohol assay - Product Code JIX
Causa
Open vial stability-potential microbial growth in the alcohol standard and possible unexpected qc changes in the ammonia portion of the control due to the lack of validation for long-term open vial stability.
Acción
Consignees were notified via recall letter dated 6/9/06 and a second letter dated 6/21/06 extending the recall to additional products/lots, to cease using the products, conduct a recall to the user level, destroy products on hand and to notify the firm via the response form of the amount destroyed for replacement purposes.
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
ligament staple impactor - Product Code HXJ
Causa
The impactors are being recalled for modification so that they can be disassembled fully for cleaning and sterilization, on suspicion that the assembled items retain contamination after cleaning and may not be effectively sterilized by the recommended hospital sterilization cycles.
Acción
Customer recall notifications included:
a) Telephone notification to highest volume users
b) Recall letters were sent via certified mail to all customers June 1, 2006.
Customers were instructed to cease using immediately and return the Impactors to Tapco. The customers were instructed to call the firm for a return authorization number. Modified loaner Impactors will be made available to customers as soon as possible.
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.
Firm received complaints indicating failure of the non-patient (np) sleeve to function properly. this sleeve covers the cannula and prevents leakage during blood collection.
Acción
BD sent out recall notifications on 6/21/2006 to distributors and their direct account 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
Vacutainer Luer Adapter - Product Code JKA
Causa
Firm received complaints indicating failure of the non-patient (np) sleeve to function properly. this sleeve covers the cannula and prevents leakage during blood collection.
Acción
BD sent out recall notifications on 6/21/2006 to distributors and their direct account 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.
Potential for measurements, lines, texts, etc to be stored incorrectly.
Acción
On 7/1/06 the firm issued a letter to consignees stating the problem and how to prevent the problem. The firm reports a software update will be issued no later than September 2006 to correct the problem.
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 oxygenator - Product Code DTZ
Causa
Cooling and rewarming time is extended. efficiency of the heat exchangers is reduced because many of the folds that are critical to heat exchange on the blood side of the units were blocked with a metalic material, thus decreasing the surface area needed for proper heat transfer.
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 oxygenator - Product Code DTZ
Causa
Cooling and rewarming time is extended. efficiency of the heat exchangers is reduced because many of the folds that are critical to heat exchange on the blood side of the units were blocked with a metalic material, thus decreasing the surface area needed for proper heat transfer.
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
Bloos oxygenator - Product Code DTZ
Causa
Cooling and rewarming time is extended. efficiency of the heat exchangers is reduced because many of the folds that are critical to heat exchange on the blood side of the units were blocked with a metalic material, thus decreasing the surface area needed for proper heat transfer.
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
Erythrocyte Fragility Test Kit - Product Code GKE
Causa
Formulation problems-lower ph of the solutions may increase red blood cell hemolysis.
Acción
Recall letters were sent via first class mail on 7/11/2005 by US mail, return receipt requested. A second notification was sent 8/4/2005
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
Alcohol assay - Product Code JIX
Causa
Open vial stability-potential microbial growth in the alcohol standard and possible unexpected qc changes in the ammonia portion of the control due to the lack of validation for long-term open vial stability.
Acción
Consignees were notified via recall letter dated 6/9/06 and a second letter dated 6/21/06 extending the recall to additional products/lots, to cease using the products, conduct a recall to the user level, destroy products on hand and to notify the firm via the response form of the amount destroyed for replacement purposes.
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
Alcohol assay - Product Code JIX
Causa
Open vial stability-potential microbial growth in the alcohol standard and possible unexpected qc changes in the ammonia portion of the control due to the lack of validation for long-term open vial stability.
Acción
Consignees were notified via recall letter dated 6/9/06 and a second letter dated 6/21/06 extending the recall to additional products/lots, to cease using the products, conduct a recall to the user level, destroy products on hand and to notify the firm via the response form of the amount destroyed for replacement purposes.
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
Alcohol Assay - Product Code JIX
Causa
Open vial stability-potential microbial growth in the alcohol standard and possible unexpected qc changes in the ammonia portion of the control due to the lack of validation for long-term open vial stability.
Acción
Consignees were notified via recall letter dated 6/9/06 and a second letter dated 6/21/06 extending the recall to additional products/lots, to cease using the products, conduct a recall to the user level, destroy products on hand and to notify the firm via the response form of the amount destroyed for replacement purposes.
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
Alcohol Assay - Product Code JIX
Causa
Open vial stability-potential microbial growth in the alcohol standard and possible unexpected qc changes in the ammonia portion of the control due to the lack of validation for long-term open vial stability.
Acción
Consignees were notified via recall letter dated 6/9/06 and a second letter dated 6/21/06 extending the recall to additional products/lots, to cease using the products, conduct a recall to the user level, destroy products on hand and to notify the firm via the response form of the amount destroyed for replacement purposes.
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
Alcohol assay - Product Code JIX
Causa
Open vial stability-potential microbial growth in the alcohol standard and possible unexpected qc changes in the ammonia portion of the control due to the lack of validation for long-term open vial stability.
Acción
Consignees were notified via recall letter dated 6/9/06 and a second letter dated 6/21/06 extending the recall to additional products/lots, to cease using the products, conduct a recall to the user level, destroy products on hand and to notify the firm via the response form of the amount destroyed for replacement purposes.
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 irrigation tubing in the tube set was assembled incorrectly with the connectors reversed.
Acción
Richard Wolf field sales representatives telephoned the end users on 7/7/06, informing them that the blue connectors on the irrigation tube may be reversed in the tube set bundle for lot 060232 only. The end users were requested to return the affected lot of tubes for replacement at no charge, contacting Ms. Ellen Huffman at 800-323-9653, ext. 280 to make arrangements for the exchange of product. Any questions concerning the recall were directed to Ms. Huffman or Robert Casarsa at the same 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 was added by ICIJ.
The parent company information is based on 2017 public records.
Notas adicionales en la data
Potassium electrode - Product Code CEM
Causa
Expired product (dated 2006.06) was shipped as replacement for recalled product.
Acción
Consignees were notified by phone and sent a recall letter dated 7/21/06 via fax, which instructed them to discontinue use of these lots of product and to discard them.
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
endoscopic suturing device - Product Code KOG
Causa
The product may lose sterility due to omission of the final pouch seal.
Acción
The firm has issued notification letters to all customers in the United States on June 29, 2006 via overnight delivery, advising customers to return all product with incomplete or missing seals to Arthocare.
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, Factor V Leiden Mutations, Genomic Dna Pcr - Product Code NPQ
Causa
If the user opens the instrument lid during decontamination, the cycle will stop but the timer will continue resulting in the user believing the instrument has been decontaminated when it has not been.
Acción
Consignees were notified via recall letter dated 7/17/06 to restart the sterilization cycle if they open the instrument for any reason during the sterilization cycle.
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, Factor V Leiden Mutations, Genomic Dna Pcr - Product Code NPQ
Causa
If the user opens the instrument lid during decontamination, the cycle will stop but the timer will continue resulting in the user believing the instrument has been decontaminated when it has not been.
Acción
Consignees were notified via recall letter dated 7/17/06 to restart the sterilization cycle if they open the instrument for any reason during the sterilization cycle.