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
Set, i.V. Fluid transfer - Product Code LHI
Causa
Tpn bags may leak during filling operation, due to bag manufacturing error.
Acción
The firm, BAXA, sent a "ExactaMix Bag Product Notice" dated March 8, 2011 to its customers. The notice described the product, problem and actions to be taken. The customers were instructed to do the following:
If they do not intend to use the manual addition port, verify that the cap is firmly seated onto the port by gently tugging on the cap.
If they do intend to use the manual addition port, they should snap off the additive port cap prior to compounding the bag.
If they encounter a faulty additive port, contact Baxa Technical Support to receive credit and/or replacement on defective product only.
To return affected bags, follow the instructions provided in the notice if the bags were purchased directly from Baxa or purchased from wholesaler, distributor or other 3rd party vendor. Additional copies of the return form can be retrieved by going to www.baxa.com/ebug OR by calling Baxa Technical Support at 800-678-2292.
If you have any questions or concerns, contact the Sr. Vice President, Quality and Regulatory at (303) 400-2838 or Baxa Technical Support at 800-678-2292.
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
Set, i.V. Fluid transfer - Product Code LHI
Causa
Tpn bags may leak during filling operation, due to bag manufacturing error.
Acción
The firm, BAXA, sent a "ExactaMix Bag Product Notice" dated March 8, 2011 to its customers. The notice described the product, problem and actions to be taken. The customers were instructed to do the following:
If they do not intend to use the manual addition port, verify that the cap is firmly seated onto the port by gently tugging on the cap.
If they do intend to use the manual addition port, they should snap off the additive port cap prior to compounding the bag.
If they encounter a faulty additive port, contact Baxa Technical Support to receive credit and/or replacement on defective product only.
To return affected bags, follow the instructions provided in the notice if the bags were purchased directly from Baxa or purchased from wholesaler, distributor or other 3rd party vendor. Additional copies of the return form can be retrieved by going to www.baxa.com/ebug OR by calling Baxa Technical Support at 800-678-2292.
If you have any questions or concerns, contact the Sr. Vice President, Quality and Regulatory at (303) 400-2838 or Baxa Technical Support at 800-678-2292.
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
Needle cannula may separate from the hub during use.
Acción
Recall letters requesting product return were mailed to all customers on October 8, 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
Set, i.V. Fluid transfer - Product Code LHI
Causa
Tpn bags may leak during filling operation, due to bag manufacturing error.
Acción
The firm, BAXA, sent a "ExactaMix Bag Product Notice" dated March 8, 2011 to its customers. The notice described the product, problem and actions to be taken. The customers were instructed to do the following:
If they do not intend to use the manual addition port, verify that the cap is firmly seated onto the port by gently tugging on the cap.
If they do intend to use the manual addition port, they should snap off the additive port cap prior to compounding the bag.
If they encounter a faulty additive port, contact Baxa Technical Support to receive credit and/or replacement on defective product only.
To return affected bags, follow the instructions provided in the notice if the bags were purchased directly from Baxa or purchased from wholesaler, distributor or other 3rd party vendor. Additional copies of the return form can be retrieved by going to www.baxa.com/ebug OR by calling Baxa Technical Support at 800-678-2292.
If you have any questions or concerns, contact the Sr. Vice President, Quality and Regulatory at (303) 400-2838 or Baxa Technical Support at 800-678-2292.
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
Set, i.V. Fluid transfer - Product Code LHI
Causa
Tpn bags may leak during filling operation, due to bag manufacturing error.
Acción
The firm, BAXA, sent a "ExactaMix Bag Product Notice" dated March 8, 2011 to its customers. The notice described the product, problem and actions to be taken. The customers were instructed to do the following:
If they do not intend to use the manual addition port, verify that the cap is firmly seated onto the port by gently tugging on the cap.
If they do intend to use the manual addition port, they should snap off the additive port cap prior to compounding the bag.
If they encounter a faulty additive port, contact Baxa Technical Support to receive credit and/or replacement on defective product only.
To return affected bags, follow the instructions provided in the notice if the bags were purchased directly from Baxa or purchased from wholesaler, distributor or other 3rd party vendor. Additional copies of the return form can be retrieved by going to www.baxa.com/ebug OR by calling Baxa Technical Support at 800-678-2292.
If you have any questions or concerns, contact the Sr. Vice President, Quality and Regulatory at (303) 400-2838 or Baxa Technical Support at 800-678-2292.
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, i.V. Start - Product Code LRS
Causa
This voluntary sub-recall was initiated because the vials of bacteriostatic sodium chloride injection, usp, 0.9% utilized to make the products may contain visible particulates.
Acción
Centurion Medical Products Corporation issued press on April 1, 2011, and sent an Urgent Voluntary Recall letter dated March 15, 2011, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer.
Customers were instructed to discontinue use of the kits immediately and instructions were provided for the return of the kits.
Customers were also asked to complete a form to fax or email back to the firm regarding the number of kits the firm has in their possession.
Customers were instructed to provide recall notification to other firm's who received the recalled kits from their direct account.
For any questions regarding this recall call 631-924-4000, ext 142.
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, i.V. Start - Product Code LRS
Causa
This voluntary sub-recall was initiated because the vials of bacteriostatic sodium chloride injection, usp, 0.9% utilized to make the products may contain visible particulates.
Acción
Centurion Medical Products Corporation issued press on April 1, 2011, and sent an Urgent Voluntary Recall letter dated March 15, 2011, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer.
Customers were instructed to discontinue use of the kits immediately and instructions were provided for the return of the kits.
Customers were also asked to complete a form to fax or email back to the firm regarding the number of kits the firm has in their possession.
Customers were instructed to provide recall notification to other firm's who received the recalled kits from their direct account.
For any questions regarding this recall call 631-924-4000, ext 142.
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.
Biopro femoral head outer packaging was found lacking proper seal ,compromising sterility.
Acción
Biopro, Inc notified all affected customers via telephone on September 21, 2011 with instructions to quarantine and return affected product to the manufacturer. The firm sent a follow up "RECALL NOTICE" dated September 29, 2011 to all affected customers. The letter described the product, problem, and actions to be taken by the customers. The letter gives instructions on how to return affected product. Contact Customer Service at 1-800-252-7707 for questions regarding this 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
Kit, i.V. Start - Product Code LRS
Causa
This voluntary sub-recall was initiated because the vials of bacteriostatic sodium chloride injection, usp, 0.9% utilized to make the products may contain visible particulates.
Acción
Centurion Medical Products Corporation issued press on April 1, 2011, and sent an Urgent Voluntary Recall letter dated March 15, 2011, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer.
Customers were instructed to discontinue use of the kits immediately and instructions were provided for the return of the kits.
Customers were also asked to complete a form to fax or email back to the firm regarding the number of kits the firm has in their possession.
Customers were instructed to provide recall notification to other firm's who received the recalled kits from their direct account.
For any questions regarding this recall call 631-924-4000, ext 142.
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, i.V. Start - Product Code MCY
Causa
This voluntary sub-recall was initiated because the vials of bacteriostatic sodium chloride injection, usp, 0.9% utilized to make the products may contain visible particulates.
Acción
Centurion Medical Products Corporation issued press on April 1, 2011, and sent an Urgent Voluntary Recall letter dated March 15, 2011, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer.
Customers were instructed to discontinue use of the kits immediately and instructions were provided for the return of the kits.
Customers were also asked to complete a form to fax or email back to the firm regarding the number of kits the firm has in their possession.
Customers were instructed to provide recall notification to other firm's who received the recalled kits from their direct account.
For any questions regarding this recall call 631-924-4000, ext 142.
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, i.V. Start - Product Code LRS
Causa
This voluntary sub-recall was initiated because the vials of bacteriostatic sodium chloride injection, usp, 0.9% utilized to make the products may contain visible particulates.
Acción
Centurion Medical Products Corporation issued press on April 1, 2011, and sent an Urgent Voluntary Recall letter dated March 15, 2011, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer.
Customers were instructed to discontinue use of the kits immediately and instructions were provided for the return of the kits.
Customers were also asked to complete a form to fax or email back to the firm regarding the number of kits the firm has in their possession.
Customers were instructed to provide recall notification to other firm's who received the recalled kits from their direct account.
For any questions regarding this recall call 631-924-4000, ext 142.
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, i.V. Start - Product Code LRS
Causa
This voluntary sub-recall was initiated because the vials of bacteriostatic sodium chloride injection, usp, 0.9% utilized to make the products may contain visible particulates.
Acción
Centurion Medical Products Corporation issued press on April 1, 2011, and sent an Urgent Voluntary Recall letter dated March 15, 2011, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer.
Customers were instructed to discontinue use of the kits immediately and instructions were provided for the return of the kits.
Customers were also asked to complete a form to fax or email back to the firm regarding the number of kits the firm has in their possession.
Customers were instructed to provide recall notification to other firm's who received the recalled kits from their direct account.
For any questions regarding this recall call 631-924-4000, ext 142.
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, i.V. Start - Product Code MCY
Causa
This voluntary sub-recall was initiated because the vials of bacteriostatic sodium chloride injection, usp, 0.9% utilized to make the products may contain visible particulates.
Acción
Centurion Medical Products Corporation issued press on April 1, 2011, and sent an Urgent Voluntary Recall letter dated March 15, 2011, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer.
Customers were instructed to discontinue use of the kits immediately and instructions were provided for the return of the kits.
Customers were also asked to complete a form to fax or email back to the firm regarding the number of kits the firm has in their possession.
Customers were instructed to provide recall notification to other firm's who received the recalled kits from their direct account.
For any questions regarding this recall call 631-924-4000, ext 142.
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, i.V. Start - Product Code LRS
Causa
This voluntary sub-recall was initiated because the vials of bacteriostatic sodium chloride injection, usp, 0.9% utilized to make the products may contain visible particulates.
Acción
Centurion Medical Products Corporation issued press on April 1, 2011, and sent an Urgent Voluntary Recall letter dated March 15, 2011, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer.
Customers were instructed to discontinue use of the kits immediately and instructions were provided for the return of the kits.
Customers were also asked to complete a form to fax or email back to the firm regarding the number of kits the firm has in their possession.
Customers were instructed to provide recall notification to other firm's who received the recalled kits from their direct account.
For any questions regarding this recall call 631-924-4000, ext 142.
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, i.V. Start - Product Code MCY
Causa
This voluntary sub-recall was initiated because the vials of bacteriostatic sodium chloride injection, usp, 0.9% utilized to make the products may contain visible particulates.
Acción
Centurion Medical Products Corporation issued press on April 1, 2011, and sent an Urgent Voluntary Recall letter dated March 15, 2011, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer.
Customers were instructed to discontinue use of the kits immediately and instructions were provided for the return of the kits.
Customers were also asked to complete a form to fax or email back to the firm regarding the number of kits the firm has in their possession.
Customers were instructed to provide recall notification to other firm's who received the recalled kits from their direct account.
For any questions regarding this recall call 631-924-4000, ext 142.
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, i.V. Start - Product Code LRS
Causa
This voluntary sub-recall was initiated because the vials of bacteriostatic sodium chloride injection, usp, 0.9% utilized to make the products may contain visible particulates.
Acción
Centurion Medical Products Corporation issued press on April 1, 2011, and sent an Urgent Voluntary Recall letter dated March 15, 2011, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer.
Customers were instructed to discontinue use of the kits immediately and instructions were provided for the return of the kits.
Customers were also asked to complete a form to fax or email back to the firm regarding the number of kits the firm has in their possession.
Customers were instructed to provide recall notification to other firm's who received the recalled kits from their direct account.
For any questions regarding this recall call 631-924-4000, ext 142.
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, i.V. Start - Product Code MCY
Causa
This voluntary sub-recall was initiated because the vials of bacteriostatic sodium chloride injection, usp, 0.9% utilized to make the products may contain visible particulates.
Acción
Centurion Medical Products Corporation issued press on April 1, 2011, and sent an Urgent Voluntary Recall letter dated March 15, 2011, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer.
Customers were instructed to discontinue use of the kits immediately and instructions were provided for the return of the kits.
Customers were also asked to complete a form to fax or email back to the firm regarding the number of kits the firm has in their possession.
Customers were instructed to provide recall notification to other firm's who received the recalled kits from their direct account.
For any questions regarding this recall call 631-924-4000, ext 142.
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, i.V. Start - Product Code LRS
Causa
This voluntary sub-recall was initiated because the vials of bacteriostatic sodium chloride injection, usp, 0.9% utilized to make the products may contain visible particulates.
Acción
Centurion Medical Products Corporation issued press on April 1, 2011, and sent an Urgent Voluntary Recall letter dated March 15, 2011, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer.
Customers were instructed to discontinue use of the kits immediately and instructions were provided for the return of the kits.
Customers were also asked to complete a form to fax or email back to the firm regarding the number of kits the firm has in their possession.
Customers were instructed to provide recall notification to other firm's who received the recalled kits from their direct account.
For any questions regarding this recall call 631-924-4000, ext 142.
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, i.V. Start - Product Code LRS
Causa
This voluntary sub-recall was initiated because the vials of bacteriostatic sodium chloride injection, usp, 0.9% utilized to make the products may contain visible particulates.
Acción
Centurion Medical Products Corporation issued press on April 1, 2011, and sent an Urgent Voluntary Recall letter dated March 15, 2011, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer.
Customers were instructed to discontinue use of the kits immediately and instructions were provided for the return of the kits.
Customers were also asked to complete a form to fax or email back to the firm regarding the number of kits the firm has in their possession.
Customers were instructed to provide recall notification to other firm's who received the recalled kits from their direct account.
For any questions regarding this recall call 631-924-4000, ext 142.
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, i.V. Start - Product Code LRS
Causa
This voluntary sub-recall was initiated because the vials of bacteriostatic sodium chloride injection, usp, 0.9% utilized to make the products may contain visible particulates.
Acción
Centurion Medical Products Corporation issued press on April 1, 2011, and sent an Urgent Voluntary Recall letter dated March 15, 2011, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer.
Customers were instructed to discontinue use of the kits immediately and instructions were provided for the return of the kits.
Customers were also asked to complete a form to fax or email back to the firm regarding the number of kits the firm has in their possession.
Customers were instructed to provide recall notification to other firm's who received the recalled kits from their direct account.
For any questions regarding this recall call 631-924-4000, ext 142.
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, i.V. Start - Product Code MCY
Causa
This voluntary sub-recall was initiated because the vials of bacteriostatic sodium chloride injection, usp, 0.9% utilized to make the products may contain visible particulates.
Acción
Centurion Medical Products Corporation issued press on April 1, 2011, and sent an Urgent Voluntary Recall letter dated March 15, 2011, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer.
Customers were instructed to discontinue use of the kits immediately and instructions were provided for the return of the kits.
Customers were also asked to complete a form to fax or email back to the firm regarding the number of kits the firm has in their possession.
Customers were instructed to provide recall notification to other firm's who received the recalled kits from their direct account.
For any questions regarding this recall call 631-924-4000, ext 142.
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, i.V. Start - Product Code MCY
Causa
This voluntary sub-recall was initiated because the vials of bacteriostatic sodium chloride injection, usp, 0.9% utilized to make the products may contain visible particulates.
Acción
Centurion Medical Products Corporation issued press on April 1, 2011, and sent an Urgent Voluntary Recall letter dated March 15, 2011, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer.
Customers were instructed to discontinue use of the kits immediately and instructions were provided for the return of the kits.
Customers were also asked to complete a form to fax or email back to the firm regarding the number of kits the firm has in their possession.
Customers were instructed to provide recall notification to other firm's who received the recalled kits from their direct account.
For any questions regarding this recall call 631-924-4000, ext 142.
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, i.V. Start - Product Code MCY
Causa
This voluntary sub-recall was initiated because the vials of bacteriostatic sodium chloride injection, usp, 0.9% utilized to make the products may contain visible particulates.
Acción
Centurion Medical Products Corporation issued press on April 1, 2011, and sent an Urgent Voluntary Recall letter dated March 15, 2011, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer.
Customers were instructed to discontinue use of the kits immediately and instructions were provided for the return of the kits.
Customers were also asked to complete a form to fax or email back to the firm regarding the number of kits the firm has in their possession.
Customers were instructed to provide recall notification to other firm's who received the recalled kits from their direct account.
For any questions regarding this recall call 631-924-4000, ext 142.
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, i.V. Start - Product Code MCY
Causa
This voluntary sub-recall was initiated because the vials of bacteriostatic sodium chloride injection, usp, 0.9% utilized to make the products may contain visible particulates.
Acción
Centurion Medical Products Corporation issued press on April 1, 2011, and sent an Urgent Voluntary Recall letter dated March 15, 2011, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer.
Customers were instructed to discontinue use of the kits immediately and instructions were provided for the return of the kits.
Customers were also asked to complete a form to fax or email back to the firm regarding the number of kits the firm has in their possession.
Customers were instructed to provide recall notification to other firm's who received the recalled kits from their direct account.
For any questions regarding this recall call 631-924-4000, ext 142.
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, i.V. Start - Product Code MCY
Causa
This voluntary sub-recall was initiated because the vials of bacteriostatic sodium chloride injection, usp, 0.9% utilized to make the products may contain visible particulates.
Acción
Centurion Medical Products Corporation issued press on April 1, 2011, and sent an Urgent Voluntary Recall letter dated March 15, 2011, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer.
Customers were instructed to discontinue use of the kits immediately and instructions were provided for the return of the kits.
Customers were also asked to complete a form to fax or email back to the firm regarding the number of kits the firm has in their possession.
Customers were instructed to provide recall notification to other firm's who received the recalled kits from their direct account.
For any questions regarding this recall call 631-924-4000, ext 142.