American Contract Systems recalled 32,433 Basic Biopsy Trays nationwide after discovering re-gassing occurred following a nonconformance during Ethylene Oxide sterilization. The trays have not been validated for exposure to multiple sterilization cycles, so product quality and safety cannot be confirmed. Healthcare providers and patients should stop using the device immediately and follow theメーカー?
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 Basic Biopsy Tray is a disposable tool used in medical procedures to collect tissue samples. It is typically employed in clinical or hospital settings under sterile conditions.
The hazard arises because some units were re-gassed after a nonconformance in EO sterilization. The products have not been validated for exposure to multiple sterilization cycles, so quality, safety, and effectiveness cannot be confirmed.
This recall is not part of a broader industry pattern.
Hospitals and clinics may need to quarantine affected lots and switch to alternative trays. The recall is active and affects thousands of units.
FDA enforcement page and manufacturer recall notification for instructions
Not specified in the recall notice
Keep the recall notice, batch/lot information, shipping records, and all correspondences with the manufacturer for records
Product: Basic Biopsy Tray Item Number: NMBP44L Brand/Manufacturer: American Contract Systems UDI-DI: 191072188120 Lot: 8515411 Quantity: 32,433 Distribution: US nationwide in SD, IA, MN, WA, IL Sold at: Unknown Price: Unknown Sold since: Unknown
No injuries or incidents have been reported.
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