FDAFDA · Food and drugs·Recall number Z-2729-2014
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.
Published October 8, 2014 · Recall initiated: May 30, 2014
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Instrumed International, Inc.
- Distributor
- 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.
- Lot
- 1) Instrumed Item No.: 250-08930; Surgical Direct Catalog Code: SD175200.100; Lot Number: 070512; 2) Instrumed Item No.: 250-08700; Surgical Direct Catalog Code: SD11451.140; Lot Number: 080211; 3) Instrumed Item No.: 250-08930; Surgical Direct Catalog Code: SD175200.100; Lot Numbers: 030112, 080212, 010113, 020113; 4) Instrumed Item No.: 250-08960; Surgical Direct Catalog Code: SD17520045.100; Lot Number: 070412; 5) Instrumed Item No.: 250-089360; Surgical Direct Catalog Code: SD175200.100; Lot Number: 030413
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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