Container, Specimen, Sterile（FMH）

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.

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 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.

Potential for microbial contamination.

Potential for microbial contamination.

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.

Product may have a weak seal which may result in a breach of sterility of the contents if the seal fails. The weak seal may not be detectable by all users.

Due to a manufacturing defect, certain Para-Pak vials may be at risk for leakage.

Plastic vials contain a manufacturing defect may cause an increased risk of leakage and presents a risk of incidental exposure to biological hazards associated with direct contact with the patient specimen.

Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications.

Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging.

Product was not irradiated; therefore, they are not sterile and do not meet product specification.

Incomplete seals on the sterile package may compromise the sterility

Cardinal Health branded specimen containers, may potentially contain plastic shavings on threaded surfaces between the closure and vial

Cardinal Health branded specimen containers, may potentially contain plastic shavings on threaded surfaces between the closure and vial

Medline notified BMD that the Aplicare Povidone Iodine (PVP-I) Prep Pads were not meeting the iodine assay level requirements to support 36 month expiration dating.

Sterility of the outer surface of the container compromised due to packaging defect.

Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.

Significant compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.

Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.