Reported Jun 21, 2017 · Terminated
Kii Shielded Bladed trocars (CTB14), Kii Low profile trocars (CTB23), and Kii 5x55mm Optical Z-Thread Dual Pack (CTR14)…
Applied Medical Resources Corp.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Applied Medical Resources Corp · 22872 Avenida Empresa · Rancho Santa Margarita, CA · 92688-2650
Is this the product you have?
- Kii Shielded Bladed trocars (CTB14), Kii Low profile trocars (CTB23), and Kii 5x55mm Optical Z-Thread Dual Pack (CTR14) trocars.
- Lot codes and dates
CTB14 (lots 127520712795421283892 and 1288910) CTB23 (lots 126969212710371282163 and 1288759) CTR14 (lots 1269694127518812790391283226and 1287785)
- Amount recalled
- 7,939 units total (870 units in US)
Why it was recalled
Due to possibility of insufficient sterilization.
This product could cause temporary or reversible health problems — stop using it.
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