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.
Electrical failure of the bed due to fluid egress into the junction box.
Action
In an October 21, 1998 e-mail the firm requested return of the product for a planned upgrade. The junction box cover was corrected at the same time of the upgrade.
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.
Notes supplémentaires dans les données
Indicator, Biological Sterilization Process - Product Code FRC
Cause
Some 3m attest steam packs 1276f (biological indicator challenge for steam sterilization) were labeled as 3m attest rapid readout steam pack 1296f.
Action
A recall letter was sent to the consignees on January 8, 2002 and requested the return 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.
Notes supplémentaires dans les données
Indicator, Biological Sterilization Process - Product Code FRC
Cause
Some 3m attest steam packs 1276f (biological indicator challenge for steam sterilization) were labeled as 3m attest rapid readout steam pack 1296f.
Action
A recall letter was sent to the consignees on January 8, 2002 and requested the return 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.
Notes supplémentaires dans les données
Gown, Surgical - Product Code FYA
Cause
An indicator inside the package did not change to indicate gowns were sterilized.
Action
The firm telephoned it's two customers on 6/4/02 and offered to have product returned or provide documentation that the sterlizing indicators were defective, and theoretically the gown packs were sterilized.
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.
Notes supplémentaires dans les données
Gown, Surgical - Product Code FYA
Cause
An indicator inside the package did not change to indicate gowns were sterilized.
Action
The firm telephoned it's two customers on 6/4/02 and offered to have product returned or provide documentation that the sterlizing indicators were defective, and theoretically the gown packs were sterilized.
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.
Notes supplémentaires dans les données
Gown, Surgical - Product Code FYA
Cause
An indicator inside the package did not change to indicate gowns were sterilized.
Action
The firm telephoned it's two customers on 6/4/02 and offered to have product returned or provide documentation that the sterlizing indicators were defective, and theoretically the gown packs were sterilized.
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.
Notes supplémentaires dans les données
Gown, Surgical - Product Code FYA
Cause
An indicator inside the package did not change to indicate gowns were sterilized.
Action
The firm telephoned it's two customers on 6/4/02 and offered to have product returned or provide documentation that the sterlizing indicators were defective, and theoretically the gown packs were sterilized.
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.
Notes supplémentaires dans les données
Gown, Surgical - Product Code FYA
Cause
An indicator inside the package did not change to indicate gowns were sterilized.
Action
The firm telephoned it's two customers on 6/4/02 and offered to have product returned or provide documentation that the sterlizing indicators were defective, and theoretically the gown packs were sterilized.
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.
Notes supplémentaires dans les données
Sharps Needle Destruction Device - Product Code MTV
Cause
Their needlezap devices were not manufactured in accordance with the quality system regulations, and were shipped without an approved pma.
Action
On 8/15/2002, the firm contacted their largest distributor by telephone and instructed them to stop distribution and to place all remaining devices in quarantine until further notice. On 3/20/2003, the firm mailed recall notices to all direct accounts asking for the device to be returned.
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.
Notes supplémentaires dans les données
Pump, Infusion, Elastomeric - Product Code MEB
Cause
Slower than expected infusion of medications, such as antibiotics.
Action
All customers were contacted by telephone on 8/19/2002. Letters were also sent dated 8/27/2002. Recall is complete.
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.
Notes supplémentaires dans les données
Syringe, Antistick - Product Code MEG
Cause
Package integrity not validated. sterility not assured.
Action
Firm initiated recall on 9/5/2002. Visits, telephone calls and letters were the tools used to implement the recall. Unused recalled units were retrieved from customers. This recall is complete.
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 i.V. filter sets contain a 1.2 micron filter instead of the labeled 0.22 micron filter.
Action
Recalled by letter dated 10/17/02. Accounts were informed of the potential for the filters to be 1.2 micron filters instead of the 0.22. micron filters as labeled. The accounts were requested to examine their inventories for the affected catalog numbers and destroy the units found for credit.
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 i.V. filter sets contain a 1.2 micron filter instead of the labeled 0.22 micron filter.
Action
Recalled by letter dated 10/17/02. Accounts were informed of the potential for the filters to be 1.2 micron filters instead of the 0.22. micron filters as labeled. The accounts were requested to examine their inventories for the affected catalog numbers and destroy the units found for credit.
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 i.V. filter sets contain a 1.2 micron filter instead of the labeled 0.22 micron filter.
Action
Recalled by letter dated 10/17/02. Accounts were informed of the potential for the filters to be 1.2 micron filters instead of the 0.22. micron filters as labeled. The accounts were requested to examine their inventories for the affected catalog numbers and destroy the units found for credit.
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 i.V. filter sets contain a 1.2 micron filter instead of the labeled 0.22 micron filter.
Action
Recalled by letter dated 10/17/02. Accounts were informed of the potential for the filters to be 1.2 micron filters instead of the 0.22. micron filters as labeled. The accounts were requested to examine their inventories for the affected catalog numbers and destroy the units found for credit.
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 i.V. filter sets contain a 1.2 micron filter instead of the labeled 0.22 micron filter.
Action
Recalled by letter dated 10/17/02. Accounts were informed of the potential for the filters to be 1.2 micron filters instead of the 0.22. micron filters as labeled. The accounts were requested to examine their inventories for the affected catalog numbers and destroy the units found for credit.
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 i.V. filter sets contain a 1.2 micron filter instead of the labeled 0.22 micron filter.
Action
Recalled by letter dated 10/17/02. Accounts were informed of the potential for the filters to be 1.2 micron filters instead of the 0.22. micron filters as labeled. The accounts were requested to examine their inventories for the affected catalog numbers and destroy the units found for credit.
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 i.V. filter sets contain a 1.2 micron filter instead of the labeled 0.22 micron filter.
Action
Recalled by letter dated 10/17/02. Accounts were informed of the potential for the filters to be 1.2 micron filters instead of the 0.22. micron filters as labeled. The accounts were requested to examine their inventories for the affected catalog numbers and destroy the units found for credit.
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 i.V. filter sets contain a 1.2 micron filter instead of the labeled 0.22 micron filter.
Action
Recalled by letter dated 10/17/02. Accounts were informed of the potential for the filters to be 1.2 micron filters instead of the 0.22. micron filters as labeled. The accounts were requested to examine their inventories for the affected catalog numbers and destroy the units found for credit.
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 i.V. filter sets contain a 1.2 micron filter instead of the labeled 0.22 micron filter.
Action
Recalled by letter dated 10/17/02. Accounts were informed of the potential for the filters to be 1.2 micron filters instead of the 0.22. micron filters as labeled. The accounts were requested to examine their inventories for the affected catalog numbers and destroy the units found for credit.
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 i.V. filter sets contain a 1.2 micron filter instead of the labeled 0.22 micron filter.
Action
Recalled by letter dated 10/17/02. Accounts were informed of the potential for the filters to be 1.2 micron filters instead of the 0.22. micron filters as labeled. The accounts were requested to examine their inventories for the affected catalog numbers and destroy the units found for credit.
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 i.V. filter sets contain a 1.2 micron filter instead of the labeled 0.22 micron filter.
Action
Recalled by letter dated 10/17/02. Accounts were informed of the potential for the filters to be 1.2 micron filters instead of the 0.22. micron filters as labeled. The accounts were requested to examine their inventories for the affected catalog numbers and destroy the units found for credit.
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 i.V. filter sets contain a 1.2 micron filter instead of the labeled 0.22 micron filter.
Action
Recalled by letter dated 10/17/02. Accounts were informed of the potential for the filters to be 1.2 micron filters instead of the 0.22. micron filters as labeled. The accounts were requested to examine their inventories for the affected catalog numbers and destroy the units found for credit.
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 i.V. filter sets contain a 1.2 micron filter instead of the labeled 0.22 micron filter.
Action
Recalled by letter dated 10/17/02. Accounts were informed of the potential for the filters to be 1.2 micron filters instead of the 0.22. micron filters as labeled. The accounts were requested to examine their inventories for the affected catalog numbers and destroy the units found for credit.