FDA (Devices) recall action 93086
The FDA (Devices) publishes a recall like this one as 12 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 12 pages.
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.
The agency’s own wording, quoted from the enforcement report.
The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.
American Contract Systems recalls cardiovascular surgical device components that were subjected to improper ethylene oxide sterilization at excessive temperatures, potentially causing loss of functionality or drug efficacy.
American Contract Systems is recalling its Robotics Pack (56 cases) due to improper sterilization of IV catheter and adhesive components. The devices may have lost functionality or drug efficacy and may contain excessive ethylene oxide residuals.
American Contract Systems is recalling CVS PCSU SJH IV catheter and adhesive components due to improper ethylene oxide sterilization. The components may have reduced functionality or elevated chemical residuals.
American Contract Systems recalled General Pack medical device components (I.V. catheters and adhesive) that were improperly sterilized with ethylene oxide at higher than approved temperatures. The components may lack functionality or have elevated sterilization residuals.
American Contract Systems recalls Pediatric Heart SJH components exposed to improper sterilization, risking functionality loss and reduced drug efficacy.
Two medical device components in the Robotics Pack (I.V. Cath and Adhesive Dermabond) were improperly sterilized and may lose functionality or drug efficacy. Affected units distributed in Florida and Iowa.
American Contract Systems is recalling Pediatric Urology Wolson Packs due to components being exposed to unapproved sterilization processes. Components may have lost functionality or reduced efficacy, potentially compromising device performance.
American Contract Systems is recalling LAVH surgical component kits because two components were subjected to improper sterilization temperatures and ethylene oxide exposure, potentially causing loss of functionality and higher chemical residuals.
American Contract Systems recalls Robotics Pack SAH components due to improper sterilization exposure. The IV catheter and adhesive components may lack functionality or contain excess sterilization residue.
American Contract Systems recalled 1260 units of Cath Cardiac Pack due to improper sterilization exposure that may cause loss of functionality or higher ethylene oxide residuals.
American Contract Systems is recalling Sub Q Recorder Pack components that were improperly sterilized using ethylene oxide at excessive temperatures. The I.V. Cath and Dermabond components may lose functionality or drug efficacy as a result.
American Contract Systems is recalling Breast Plastics Pack components because they were subjected to inappropriate sterilization that may cause loss of functionality or drug efficacy and increased ethylene oxide residuals.