FDAHealthSeptember 4, 2025
American Contract Systems Inc. — Basic Biopsy Tray, Item Number NMBP44L
⚠️ 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.
Is this relevant to me?
- Geography
- Nationwide
- Source agency
- FDA
- Category
- Health
- Published
- September 4, 2025
US Nationwide distribution in the states of SD, IA, MN, WA, IL.
What's affected?
- Product
- Basic Biopsy Tray, Item Number NMBP44L
- Lot code
- 8515411
Additional details
UDI-DI 191072188120 Lot 8515411 Entire lot impacted
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 32,433 total.
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