American Contract Systems recalled 32,433 Basic Biopsy Trays on September 4, 2025. The recall resulted from products being re-gassed after a sterilization failure. The company cannot confirm the safety or effectiveness of these devices after multiple sterilization cycles.
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.
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact American Contract Systems Inc. or your healthcare provider for instructions. Notification method: Letter
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The recalled product is the Basic Biopsy Tray, Item Number NMBP44L. The entire lot impacted is UDI-DI 191072188120 Lot 8515411. These trays were distributed nationwide across South Dakota, Iowa, Minnesota, Washington, and Illinois.
The recall stems from a nonconformance during the initial Ethylene Oxide gas injection process. Products were re-gassed, which violates sterilization protocols, raising concerns about their quality and safety.
No specific incidents of injury or death related to this recall have been reported. The high hazard classification indicates potential serious risks associated with using the device.
Stop using the Basic Biopsy Tray immediately. Follow the recall instructions provided by American Contract Systems. Contact the manufacturer or your healthcare provider for further guidance.
For further assistance, contact American Contract Systems Inc. via their website or the FDA recall page at https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?recall_number=Z-0170-2026.
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