Recall Z-1846-2016— STERILMED, INC.
Class II · Terminated
Class II FDA medical device recall by STERILMED, INC., initiated 2016-04-26, terminated 2017-04-05. It names one FDA 510(k) clearance: K073613. Product: 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.. Reason: Sterlilmed is recalling all unexpired Scissor Tips because of a potential manufacturing defect that can possibly result in a patient injury..
- Recalling firm
- STERILMED, INC.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2016-04-26
- Terminated
- 2017-04-05
- Firm location
- Maple Grove, MN, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product 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.
Reason for recall
Sterlilmed is recalling all unexpired Scissor Tips because of a potential manufacturing defect that can possibly result in a patient injury.
Data sourced from openFDA. This site is unofficial and independent of the FDA.