Endoscope Introducer Kit

Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows:

During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indicating that in-market product may be out-of-specification for endotoxin.

Medical convenience kits

Identified products were re-gassed (sterilized more than once) after a nonconformance occurred during the initial Ethylene Oxide (EO) gas injection process. These products have not been validated for exposure to multiple sterilization cycles. Therefore, product quality, safety, and effectiveness cannot be confirmed for product that was re-gassed.

AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as:

During an internal investigation, ACS determined that the rationale for sterilization of certain components was not justified and therefore, some components are not fit for further sterilization according to ACS procedures. As a result, ACS is unable to confirm product sterilization assurance requirements were met.

Medline procedure 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.

Brand Name: Banner Health Systems

Sterility assurance with procedure trays

CYSTO PACK

ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of functionality may lead to delay or prolonged treatment.

CYSTO

ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of functionality may lead to delay or prolonged treatment.

Cardinal Health Presource Kits:

Potential for endotoxin contamination in non-sterile surgical strips and patties in Presource Kits.

Cardinal Health Presource Kits:

Potential endotoxin contamination in non-sterile surgical strips and patties in Presource kits.

Medline custom medical procedure kits labeled as:

Custom convenience kits are being recall because the contain non-sterile Codman Surgical Patties & Surgical Strips, which have the potential for endotoxin contamination.