The Czech language user guide contained multiple translation errors. The most significant error was that it incorrectly instructs users to verify that the infusion set is connected to the body, when it should instead direct users to confirm that the infusion set is not connected to the body. Following this instruction could result in unintended insulin delivery, potentially leading to a hypoglycemic event.
The Czech language user guide contained multiple translation errors. The most significant error was that it incorrectly instructs users to verify that the infusion set is connected to the body, when it should instead direct users to confirm that the infusion set is not connected to the body. Following this instruction could result in unintended insulin delivery, potentially leading to a hypoglycemic event.
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Tandem Diabetes Care, Inc. or your healthcare provider for instructions. Notification method: Letter
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Tandem pumps are battery-operated infusion pumps capable of both basal and bolus delivery of insulin. The pumps utilize a motor-driven mechanism to deliver insulin from within a disposable cartridge, through an infusion set, into a patient s subcutaneous tissue. As with current insulin infusion pumps on the U.S. market, the desired timing and quantity of the insulin delivery is programmed by the user (i.e., the patient).. Reason: The Czech language user guide contained multiple translation errors. The most significant error was that it incorrectly instructs users to verify that the infusion set is connected to the body, when it should instead direct users to confirm that the infusion set is not connected to the body. Following this instruction could result in unintended insulin delivery, potentially leading to a hypoglycemic event.. Classification: Class II. Quantity: 1,380 units. Distribution: International distribution in the countries of Czech Republic, Slovakia.
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Lack of Assurance of Sterility: Quality system deficiencies identified during a routine U.S Food and Drug Administration (FDA) inspection at the contract manufacturer.
Lack of Assurance of Sterility
A material mix-up had occurred during the manufacturing of Straumann¿ Custom Abutments. More specifically, a raw material bar of TAN-material (SAP #701924 / Lot 7130439) was incorrectly identified as a Titanium Bar Ti Gr4 D (SAP #701922 / Lot 7130430). As a result, RC Titanium abutments were manufactured using the TAN Bar material on Mill-from-Bar Machine 396-06.
A material mix-up had occurred during the manufacturing of Straumann¿ Custom Abutments. More specifically, a raw material bar of TAN-material (SAP #701924 / Lot 7130439) was incorrectly identified as a Titanium Bar Ti Gr4 D (SAP #701922 / Lot 7130430). As a result, RC Titanium abutments were manufactured using the TAN Bar material on Mill-from-Bar Machine 396-06.
Lack of Assurance of Sterility: Quality system deficiencies identified during a routine U.S Food and Drug Administration (FDA) inspection at the contract manufacturer.
Lack of Assurance of Sterility: Quality system deficiencies identified during a routine U.S Food and Drug Administration (FDA) inspection at the contract manufacturer.
Failed tablet specifications.
Failed Tablet/Capsule specifications: Red dots inside capsule and melted capsule caused by oxidized Icosapent ethyl, the active ingredient.