Chest Drainage Kit

Description/REF:

Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was found to have quality issues and limited reports of drug ineffectiveness, and if sterility of a water-based injectable product is compromised this could lead to serious or life-threatening injuries.

Medline convenience kit:

Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may crack during actuation and render product unusable for application.

Medline Convenience Kits:

Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.

Medline Convenience Kits:

Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.

Medline Convenience kits used for various procedures:

There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits.

Medline Convenience kits labeled as:

Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.

Ocean Water Seal Chest Drain, Single Collection W/AC,

Chest drains have a missing o-ring

Ocean Water Seal Chest Drain, SINGLE W/AC

Chest drains have a missing o-ring

Oasis Dry Suction Water Seal Chest Drain, DRY SINGLE W/AC

Chest drains have a missing o-ring

EXPRESS Dry Seal Chest Drain, Single Collection

Chest drains have a missing o-ring