Recall Z-1846-2016 ยท NUJ Electrosurgical, Cutting & Coagulation Accessories, Laparoscopic & Endoscopic, Reprocessed
STERILMED, INC.
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.
| Date | May 31, 2016 (initiated Apr 26, 2016) |
| Status | Terminated |
| Reason | Sterlilmed is recalling all unexpired Scissor Tips because of a potential manufacturing defect that can possibly result in a patient injury. |
| Root cause | Process design |
| Action | 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 Ca |
| Quantity | 11,326 |
| Distribution | 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K073613 | REPROCESSED SCISSOR TIPS Sterilmed, Inc., Feb 12, 2008 |