Reprocessed Microline Scissor Tips intended to be used with a reusable hand piece and designed for minimally invasive and open surgical procedures to facilitate cutting, preparation, mobilization, and coagulation of tissue. Model #'s MIC3112, MIC3122, MIC3132, MIC3142, MIC3152, MIC3162.
Recall
- Recall Number
- Z-1846-2016
- Event Number
- 73871
- Firm
- STERILMED, INC.
- FEI Number
- 3001237663
- Product Code
- NUJ
- Status
- Terminated
- Root Cause
- Process design
- Initiated
- April 26, 2016
- Posted
- May 31, 2016
- Terminated
- April 5, 2017
- Address
- 11400 73rd Ave N, Maple Grove, MN, 55369-5561
Description
Reprocessed Microline Scissor Tips intended to be used with a reusable hand piece and designed for minimally invasive and open surgical procedures to facilitate cutting, preparation, mobilization, and coagulation of tissue. Model #'s MIC3112, MIC3122, MIC3132, MIC3142, MIC3152, MIC3162.
Sterlilmed is recalling all unexpired Scissor Tips because of a potential manufacturing defect that can possibly result in a patient injury.
Consignees were sent on /26/2016 a Sterilmed "Urgent Medical Device Recall" letter dated April 26, 2016. The letter was addressed to either Materials Manager, Risk Manager and Operating Room Director or Distributor. The letter described the problem, the product involved in the recall and the actions required. Advised consignees to immediately quarantine and return the affected product and to complete and return the "Business Reply Form" to Sterilcycle. Advised Distributors to forward the letter to their customers if product was sent to them. For questions contact Sterilmed's Customer Care Team at 1-888-541-0078 .
US: AL, AR, CA, CO, FL, GA, IN,IA, KY, MD, MA, MI, MN, MO, NV, NJ, NC, OH, OK, OR, PA,, SC, TN, TX, VA, WA, WV, WI. Canada
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