Other Medical Devices

The type of screw printed on the traceability record for the patient label is incorrect, but the type of screw printed on the other labeling is correct.

Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lots received between 06/01/21-9/30/21.

Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lots received between 06/01/21-9/30/21.

Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lots received between 06/01/21-9/30/21.

Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lots received between 06/01/21-9/30/21.

Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lots received between 06/01/21-9/30/21.

Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lots received between 06/01/21-9/30/21.

Kits mislabeled as latex-free, the packaging for component 94-7002 Non-Adherent Dressing contains natural rubber latex. Potential risk to to those with latex allergy

Affected product was not appropriately stored in temperature-controlled areas between April 30, 2022 - June 10, 2022.

Affected product was not appropriately stored in temperature-controlled areas between April 30, 2022 - June 10, 2022.

Outer carton packaging of microcatheters were exposed to wet substance during transport.

Affected product was not appropriately stored in temperature-controlled areas between April 30, 2022 - June 10, 2022.

Affected product was not appropriately stored in temperature-controlled areas between April 30, 2022 - June 10, 2022.

Affected product was not appropriately stored in temperature-controlled areas between April 30, 2022 - June 10, 2022.

Affected product was not appropriately stored in temperature-controlled areas between April 30, 2022 - June 10, 2022.

Affected product was not appropriately stored in temperature-controlled areas between April 30, 2022 - June 10, 2022.

The sterile barrier may be compromised.

Affected product was not appropriately stored in temperature-controlled areas between April 30, 2022 - June 10, 2022.

Affected product was not appropriately stored in temperature-controlled areas between April 30, 2022 - June 10, 2022.

Affected product was not appropriately stored in temperature-controlled areas between April 30, 2022 - June 10, 2022.