FDA (Devices) recall action 96343
The FDA (Devices) publishes a recall like this one as 32 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 32 pages.
ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of functionality may lead to delay or prolonged treatment.
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 Inc is recalling CYSTO PACK cystoscopy kits because the company cannot confirm sterilization assurance requirements were met. Possible loss of functionality could delay or prolong patient treatment.
American Contract Systems Inc. is recalling 303 Laparoscopy Packs (Models CALS41F, CALS41F-01, CALS41G) because sterilization assurance requirements could not be confirmed. Unsterilized instruments may cause infection or delayed treatment.
American Contract Systems Inc is recalling 144 CYSTO Model SACY80R kits due to inability to confirm sterilization requirements were met. Unsterilized devices may lose functionality and delay patient treatment.
American Contract Systems Inc is recalling Neuro IR Tray (Model WENI56J) due to inability to confirm sterilization assurance. Loss of functionality could delay or prolong treatment.
American Contract Systems Inc is recalling 1,200 DR DIULUS Injection Pack kits because the manufacturer cannot confirm sterilization assurance requirements were met. This may result in loss of functionality and treatment delays.
American Contract Systems Inc is recalling 90 Open Heart Adult Side A surgical kits due to inability to confirm sterilization requirements were met. Unsterilized devices could lose functionality and delay patient treatment.
American Contract Systems cannot confirm Major Vascular Pack surgical kits were properly sterilized. Sterilization assurance failure could result in loss of functionality and delayed patient treatment.