American Contract Systems, Inc.: Device Recall

Recall Details

Recall Number

Z-2517-2024

Classification

Class II

Product Type

Device

Recalling Firm

American Contract Systems, Inc.

Status

Ongoing

Date Initiated

05/06/2024

Location

Kansas City, MO, United States

Voluntary/Mandated

Voluntary: Firm initiated

Product Quantity

90

Reason for Recall

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

Product Description

American Contract Systems Hand Pack convenience kit

Distribution Pattern

US Nationwide distribution in the states of CA, KS, ME, MN, MO, NE, and SD.

Other Recalls by American Contract Systems, Inc.

• Class II: Risk 09/04/2025
  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.
• Class II: Risk 09/04/2025
  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.
• Class II: Risk 09/04/2025
  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.
• Class II: Risk 09/04/2025
  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.
• Class II: Risk 09/04/2025
  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.

View all recalls by American Contract Systems, Inc. →