Reusable laparoscopic instruments are packaged as non-sterile. Cleaning and sterilization of devices must occur prior to

FDA device recall Z-2727-2014 · posted 2014-09-30 · Terminated

Recall details

Recalling firm

Instrumed International, Inc.

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.

Action taken

Instrumed sent an URGENT: MEDICAL DEVICE CORRECTION letters dated May 30, 2014 to all consignees. The letters advised the consignees of the new warning statements on the product Instructions For Use and an instruction to complete and return the attached Response Request Form to Instrumed International. Consignees were further instructed to extend the recall to the retail level. For questions contact Instrumed Quality Manager at 847-908-6119.

Root cause

Labeling design

Status

Terminated

Product code

GEI

Quantity affected

895 instruments

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,

Date initiated

2014-05-30

Date posted

2014-09-30

Date terminated

2017-11-29

Location

Schaumburg, IL

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