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.
FDA Recall Z-1846-2016 · Posted 2016-05-31
Advertisement
Recalling FirmSTERILMED, INC.
Recall StatusTerminated
Product CodeNUJ
Date Initiated2016-04-26
Date Terminated2017-04-05
Product Quantity11,326
Reason for Recall
Sterlilmed is recalling all unexpired Scissor Tips because of a potential manufacturing defect that can possibly result in a patient injury.
Firm 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 Care Team at 1-888-541-0078 .
Root Cause
Process design
Distribution Pattern
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
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
Advertisement