Z-2722-2014 Class II Terminated
FDA device recall Z-2722-2014 was initiated by Instrumed International, Inc. on May 30, 2014 and is designated Class II. 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… The recall status is terminated (terminated Nov 29, 2017). Affected quantity: 2 instruments.
Recall Details
- Product Type
- Devices
- Report Date
- Oct 8, 2014
- Initiation Date
- May 30, 2014
- Termination Date
- Nov 29, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2 instruments
Product Description
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.
Distribution Pattern
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.
Code Information
1) Instrumed Item No.: 250-08930; Ambler Surgical Corporation Catalog Code: J647-6; Lot Number: 060412;
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-2722-2014
- openFDA file date
- Oct 27, 2026
- Loaded by RegDataLab
- Oct 29, 2026