American Contract Systems, Inc.: Device Recall

Recall Details

Recall Number

Z-3227-2024

Classification

Class II

Product Type

Device

Recalling Firm

American Contract Systems, Inc.

Status

Ongoing

Date Initiated

08/07/2024

Location

Kansas City, MO, United States

Voluntary/Mandated

Voluntary: Firm initiated

Product Quantity

93 units

Reason for Recall

ACS identified that due to an inoperable chart recorder, humidity readings were out-of-specification in one of the controlled environment areas. As a result, ACS is unable to confirm product sterilization assurance requirements were met.

Product Description

Endovascular AAA Pack, ESED52B; Medical convenience kit

Distribution Pattern

US Nationwide distribution in the states of MO, MN, MA, OH, NE.

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. →