American Contract Systems, Inc. recalls
10 recalls on record · FDA
Every recall we have on record for American Contract Systems, Inc., compiled from federal safety data. Check the hazard, the remedy, and how serious each one is, and always confirm on the official notice.
Brand Name: Banner University Med Ctr. Product Name: Cardiac Cath Lab Pack-170278 …
Sterility assurance with procedure trays
Pacemaker, COPM11B; Medical convenience kit
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.
Hand Pack, AKHD97C; Medical convenience kit
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.
LAVH, REF BBLV21C
During an internal investigation, ACS identified that the components, I.V. Cath (part number 4252535-02) and Adhesive Dermabond (part number DHVM12) were inadvertently subjected to the ACS sterilization process and exposed to EO and higher temperatures than approved by the component manufacturer. As a result, the components may (1) have a loss/lack of functionality, (2) loss of drug efficacy, if applicable, and (3) have higher than specified EO residuals.
Robotics Pack SAH, REF SAR530M
During an internal investigation, ACS identified that the components, I.V. Cath (part number 4252535-02) and Adhesive Dermabond (part number DHVM12) were inadvertently subjected to the ACS sterilization process and exposed to EO and higher temperatures than approved by the component manufacturer. As a result, the components may (1) have a loss/lack of functionality, (2) loss of drug efficacy, if applicable, and (3) have higher than specified EO residuals.
Robotics Pack, REF SJVO56B
During an internal investigation, ACS identified that the components, I.V. Cath (part number 4252535-02) and Adhesive Dermabond (part number DHVM12) were inadvertently subjected to the ACS sterilization process and exposed to EO and higher temperatures than approved by the component manufacturer. As a result, the components may (1) have a loss/lack of functionality, (2) loss of drug efficacy, if applicable, and (3) have higher than specified EO residuals.
Various Angiography packs/trays
Product was exposed to multiple sterilization cycles without validation for multiple exposures.
Breast Abdominoplasty Pack
Product was exposed to multiple sterilization cycles without validation for multiple exposures.
Various C-section packs
Product was exposed to multiple sterilization cycles without validation for multiple exposures.
Various convenience packs
Product was exposed to multiple sterilization cycles without validation for multiple exposures.