Medical device recalls

False positive warning may occur after: 1) VNS Generator interrogated at 0mA normal output current, 2) Generator programmed to non-0mA output current, 3) In-session re-interrogation performed. Users instructed to lower output current and widen pulse width. Only system diagnostic testing evaluates output current. Users may conclude device malfunction, could lead to medical/surgical intervention.

The company identified potential interference from hydroxyurea. Patient use of the anti-neoplastic drug may falsely elevate glucose readings on the Continuous Glucose Monitoring Systems.

The company identified potential interference from hydroxyurea. Patient use of the anti-neoplastic drug may falsely elevate glucose readings on the Continuous Glucose Monitoring Systems.

The company identified potential interference from hydroxyurea. Patient use of the anti-neoplastic drug may falsely elevate glucose readings on the Continuous Glucose Monitoring Systems.

During total knee arthroplasty (TKA), the software may incorrectly calculate femur resection depth.

Instructions sent in a letter or in instructions for use for disinfecting blood glucose and/or ketone meters were distributed but not cleared by the U.S. FDA, and devices were not cleared for multiple-patient use. Instructions could lead to inappropriate meter disinfection or improper handling of contaminated meters, which may cause infection or exacerbation of an existing infection.

Instructions sent in a letter or in instructions for use for disinfecting blood glucose and/or ketone meters were distributed but not cleared by the U.S. FDA, and devices were not cleared for multiple-patient use. Instructions could lead to inappropriate meter disinfection or improper handling of contaminated meters, which may cause infection or exacerbation of an existing infection.

Instructions sent in a letter or in instructions for use for disinfecting blood glucose and/or ketone meters were distributed but not cleared by the U.S. FDA, and devices were not cleared for multiple-patient use. Instructions could lead to inappropriate meter disinfection or improper handling of contaminated meters, which may cause infection or exacerbation of an existing infection.

Potential for tip detachment of Imager II 5F Angiographic Catheters

There is a software issue which may result in failure to monitor or control patient's bed exit mechanism.

In certain scenarios, the Omnipod DASH PDM may suggest an inaccurate bolus amount based on a blood glucose value that is more than 10 minutes old when the user does not exit the bolus calculator as designed or when a system alarm interrupts a bolus calculation. If the user delivers the bolus, this may lead to hypoglycemia or hyperglycemia.

Due to an error in the programming of the Control CODE CHIP module for this lot, a failing result is inappropriately displayed for AMP and mAMP. This issue results in the Triage Meter displaying a failing control result for the AMP and mAMP tests when the control did not fail.

Samples of 114gm tubes of Lemon Prep, collected during a Food and Drug Administration inspection on October 15, 2019 were tested and found to be contaminated with Burkholderia cepacia. Mavidon is recalling all products manufactured at their facility.

Samples of 114gm tubes of Lemon Prep, collected during a Food and Drug Administration inspection on October 15, 2019 were tested and found to be contaminated with Burkholderia cepacia. Mavidon is recalling all products manufactured at their facility.

Samples of 114gm tubes of Lemon Prep, collected during a Food and Drug Administration inspection on October 15, 2019 were tested and found to be contaminated with Burkholderia cepacia. Mavidon is recalling all products manufactured at their facility.

Samples of 114gm tubes of Lemon Prep, collected during a Food and Drug Administration inspection on October 15, 2019 were tested and found to be contaminated with Burkholderia cepacia. Mavidon is recalling all products manufactured at their facility.

The control target and range value for Sodium using the ISE indirect method has been assigned incorrectly.

Voids were discovered in the packaging seal and loss of sterility on the outside of the contents within the Tyvek Form-Fill-Seal packaging.

Voids were discovered in the packaging seal and loss of sterility on the outside of the contents within the Tyvek Form-Fill-Seal packaging.

Voids were discovered in the packaging seal and loss of sterility on the outside of the contents within the Tyvek Form-Fill-Seal packaging.

A 15mm Shoulder Mini Humeral Stem was misidentified as a 9mm Shoulder Mini Humeral Stem.

There is potential for the blister tray to be cracked causing the sterile barrier to be compromised and potential for particulate within the sterile barrier.

Bilirubin assays may exhibit a positive bias with patients on eltrombopag therapy

Bilirubin assays may exhibit a positive bias with patients on eltrombopag therapy

Bilirubin assays may exhibit a positive bias with patients on eltrombopag therapy

Bilirubin assays may exhibit a positive bias with patients on eltrombopag therapy

Bilirubin assays may exhibit a positive bias with patients on eltrombopag therapy

Bilirubin assays may exhibit a positive bias with patients on eltrombopag therapy

The Leukocyte and Compensation pads were switched on some vials of lot number 7212269M of the iChem VELOCITY Strips.

The top seal of some of the pouches was compromised which can allow moisture to enter that can impact some antibiotics on the card.