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 recalls the Born on Arrival Kit due to inability to confirm sterilization assurance. Unsterilized equipment could delay or prolong newborn treatment.
American Contract Systems unable to confirm sterilization of 956 General Angio Pack kits distributed nationwide. Unsterile devices may lose functionality and delay patient treatment.
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 recalls 690 laceration tray kits due to inability to confirm sterilization requirements were met. The trays may lack functionality and delay 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 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 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 Inc is recalling 106 SPINE LUMBAR PACK kits (Models UTSL72AA, UTSL72AB) because the manufacturer cannot confirm sterilization assurance requirements were met, potentially causing functionality loss and treatment delays.
American Contract Systems Inc is recalling 170 Diagnostic Neuro IR Tray kits due to inability to confirm sterilization assurance requirements were met. The units may lose functionality and cause treatment delays.
American Contract Systems recalls 40 kits of Thoracic Packs (Models UTTC82Y and UTTC82AA-01) due to inability to confirm sterilization assurance was met. Unsterilized packs may lose functionality and delay emergency treatment.
American Contract Systems Inc is recalling TOTAL HIP PACK models SMTH06O and SMTH06P due to inability to confirm sterilization requirements were met. Unsterilized devices could malfunction and delay patient treatment.
American Contract Systems Inc recalls HIP SCOPE orthopedic surgical kits due to inability to confirm sterilization assurance requirements were met. Unsterilized instruments could increase infection risk during surgical procedures.
American Contract Systems Inc is recalling 134 CV Basic Pump Pack kits because the manufacturer cannot confirm sterilization requirements were met. Possible loss of functionality could delay or prolong patient treatment.
American Contract Systems Inc is recalling 51 kits of the EAR PACK Model SFEA12A because the manufacturer could not confirm sterilization requirements were met, which could cause device malfunction and delayed treatment.
American Contract Systems Inc is recalling 90 AV Fistula kits because sterilization assurance requirements cannot be confirmed. Possible loss of functionality could delay or prolong patient treatment.
American Contract Systems Inc is recalling Delivery Pack medical devices (Models SGDV22D-01 and SGDV22E) because sterilization assurance requirements were not confirmed. Unsterilized devices may not function properly and could delay treatment.
American Contract Systems is recalling C-Section surgical packs (252 kits) after being unable to confirm sterilization assurance. Lack of verified sterilization could delay or prolong surgical treatment.
American Contract Systems Inc is recalling C-Section PPS positioning systems due to inability to confirm sterilization assurance requirements were met. The failure could lead to loss of functionality and delayed treatment.
American Contract Systems Inc recalls 41 URO Robotic Pack surgical kits distributed in Ohio because sterilization assurance requirements could not be confirmed. Non-sterile equipment may lead to delayed treatment.
American Contract Systems Inc is recalling 630 laparoscopy pack kits due to unconfirmed sterilization assurance. This could cause loss of functionality and treatment delays.
American Contract Systems is recalling 725 Labor & Delivery Packs because the manufacturer cannot confirm sterilization requirements were met. Devices may lack functionality and could delay or prolong patient treatment.
American Contract Systems Inc recalled 690 laceration trays because the company cannot confirm sterilization assurance requirements were met. The recalled devices may lose functionality, potentially delaying or prolonging patient treatment.
American Contract Systems Inc is recalling OPEN HEART A PACK surgical training kits (Models UTOH19AI, UTOH19AJ-01, UTOH19AJ-02) because sterilization assurance requirements cannot be confirmed. Lack of sterilization could impair functionality.
American Contract Systems is recalling 1,836 Labor and Delivery PPS kits due to inability to confirm sterilization requirements were met. The affected units may lose functionality, potentially delaying patient treatment.
American Contract Systems Inc is recalling 17 MAJOR DIEP surgical kits because sterilization assurance requirements cannot be confirmed. This creates a risk of device malfunction and treatment delays.