Z-0095-2014 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- November 6, 2013
- Initiation Date
- July 31, 2013
- Termination Date
- June 29, 2015
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 102 units
Product Description
PIPELINE LS ACCESS SYSTEM, 3rd Dilator, 14 mm Insulated The PIPELINE LS Dilators and Holding Clip are intended for sequential dilation of soft tissue and enabling proper placement of the Pipeline LS Retractor.
Reason for Recall
Dilators and Holding Clip are being used for a secondary function of neuromonitoring, for which it is not 510(k) cleared.
Distribution Pattern
Nationwide Distribution including the states of AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MT, NC, ND, NE, NH, NJ, NY, OH, OK, OR, PA, SC, SD, TN, TX, VA, WA, WI, WV, and WY.
Code Information
287105014