Applied Medical Recalls Kii Trocars Due to Sterilization Concerns
Applied Medical Resources Corp is recalling specific Kii trocars due to the possibility of insufficient sterilization. The recall affects 7,939 units distributed in the US and worldwide.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II. The hazard involves a risk-of-harm product (insufficient sterilization) where no specific injuries or illnesses have been reported in the source text, fitting the criteria for a High severity score.
Plain-English summary
Applied Medical Resources Corp is voluntarily recalling Kii Shielded Bladed trocars (CTB14), Kii Low profile trocars (CTB23), and Kii 5x55mm Optical Z-Thread Dual Pack (CTR14) trocars. The recall is being conducted due to the possibility of insufficient sterilization of the devices.
A total of 7,939 units are affected, with 870 units distributed in the United States. The remaining units were distributed worldwide, including in Australia, Finland, France, and the United Kingdom. Specific lot numbers for the CTB14, CTB23, and CTR14 models are identified in the recall documentation.
Healthcare providers and consumers should stop using the affected trocars and contact Applied Medical Resources Corp for further instructions on returns or replacements.
The recalled product
- Product
- Kii Shielded Bladed trocars (CTB14), Kii Low profile trocars (CTB23), and Kii 5x55mm Optical Z-Thread Dual Pack (CTR14) trocars.
- Manufacturer
- Applied Medical Resources Corp
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (9)
- CTB14 (lots 1275207
- 1279542
- 1283892 and 1288910) CTB23 (lots 1269692
- 1271037
- 1282163 and 1288759) CTR14 (lots 1269694
- 1275188
- 1279039
- 1283226
- and 1287785)
Distribution
Distribution scope not specified by the agency.
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