Instrumed International, Inc. Recall: Reusable laparoscopic instruments are packaged as no
Instrumed International, Inc. Recall: Reusable laparoscopic instruments are packaged as no is one of 9,000 recalls in the RecallGuard dataset. Key details — Recalling firm: Instrumed International, Inc.; Product: Reusable laparoscopic instruments are packaged as non-sterile. Cleaning and sterilization of devices must o
| Recalling firm | Instrumed International, Inc. |
|---|---|
| Product | Reusable laparoscopic instruments are packaged as non-sterile. Cleaning and sterilization of devices must occur prior to use. The instruments are intended to be used by qualified physicians to provide access, illumination and visualization of internal structures and for manipulating soft tissue (grasping, cutting, coagulating, dissecting and suturing) in a wide variety of diagnostic and therapeutic laparoscopic/ urologic closed and minimally invasive procedures. It is inserted via a trocar sleeve and is used to prepare, coagulate and cut tissue. |
| Reason for recall | Additional caution statements have been added to the Instructions For Use for monopolar electrodes. 1) To avoid tissue carbonation, the operation voltage of the HF generator must not exceed 650 peak voltage (Vp) for all monopolar electrodes. and 2) For all monopolar electrodes, the useful life of this product is less than or equal to 50 cycles and less than or equal to 2 years. |
| Classification | Class II (moderate — may cause temporary or reversible health consequences) |
| Status | Terminated |
| Distribution | Distribution US Nationwide in the states of: AL, AR, AZ, CA, CO, CT, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV, and WY. |
| Recall initiated | 20140530 |
| Recall number | Z-2721-2014 |
| Category | device |
| State | IL |
| Country | United States |
$29/mo
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