Tray, Biopsy, Without Biopsy Instruments（FCH）

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.

Product released with insufficient aeration time impacting the kits sterilized on the same cycle or in the same aeration chamber, which may have been compromised in sterility

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.

During an internal investigation, ACS identified that several components were "piggybacked" to ACS trays and subjected to the ACS sterilization process. There is no supporting documentation stating the "piggybacked" components were assessed to determine if they were suitable for exposure to elevated temperatures for an extended period of time and further exposure to sterilization. As a result, the piggybacked components may (1) have a loss/lack of functionality, (2) loss of drug efficacy, if applicable, and (3) may have had higher than specified EO residuals.

Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams.

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

The convenience trays had improper placement of some of the components that were in the nonsterile portion of the tray, thus, not receiving sterilization.

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

Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professional Disposables International (PDI), that are subject to a drug recall due to uncertainty of the adequacy of the validation of the test methods used to manufacture the drug products

Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professional Disposables International (PDI), that are subject to a drug recall due to uncertainty of the adequacy of the validation of the test methods used to manufacture the drug products

Covidien issued a labeling update for the Covidien Devon Light Gloves. Busse had incorporated the affected gloves in several kits and distributed them prior to receipt of the recall notification.

Sterility of syringe product could not be assured.

Surgical procedure trays are packed with pharmaceuticals for injection that may contain particulate matter.

Surgical procedure trays are packed with pharmaceuticals for injection that may contain particulate matter.