Non-sterile procedural trays labeled as MAJOR/MINOR, 3 per case — recall Z-1032-2023
U.S. FDA — Device Enforcement · United States · 2022-11-17 · Class II
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Reported risk: Potential for sterile blades, within non-sterile SPT kits containing the blades, to puncture the outer foil layer causing a breach in the sterile packaging.
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