Applied Medical Resources recalled 450 units of the Kii Low Profile, Bladed Dual Pack on December 11, 2025, due to a potential safety issue. The blade obturator may extend beyond safe limits after assembly, posing a risk to patients. Healthcare providers and patients should stop using the device immediately.
There is the potential for extended length of the blade obturator after assembly into the cannula and seal housing.
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Applied Medical Resources Corp or your healthcare provider for instructions. Notification method: Letter
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The recalled product is the Kii Low Profile, Bladed Dual Pack, REF: CTB23. It has a UDI of (01)00607915126582 and Lot # 1546141. The product was distributed in Michigan, California, and Maine, as well as France, Great Britain, and Germany.
The hazard involves the potential for an extended length of the blade obturator after assembly into the cannula and seal housing. This defect could pose serious risks in medical procedures.
No specific incidents or injuries have been reported related to this recall as of now. The recall is classified as high risk due to the potential severity of the hazard.
Patients and healthcare providers should stop using the device immediately. Follow the recall instructions provided by Applied Medical Resources Corp. Contact your healthcare provider for further guidance.
For more information, contact Applied Medical Resources Corp. Visit the FDA recall page at https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?recall_number=Z-1010-2026.
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