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U.S. Department of Health and Human Services

Class 2 Device Recall PIPELINE LS ACCESS SYSTEM

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  Class 2 Device Recall PIPELINE LS ACCESS SYSTEM see related information
Date Initiated by Firm July 31, 2013
Date Posted October 23, 2013
Recall Status1 Terminated 3 on June 29, 2015
Recall Number Z-0097-2014
Recall Event ID 65897
Product Classification Dilator, catheter - Product Code GCC
Product PIPELINE LS ACCESS SYSTEM, Holding Clip

The PIPELINE LS Dilators and Holding Clip are intended for sequential dilation of soft tissue and enabling proper placement of the Pipeline LS Retractor.
Code Information 287105090
Recalling Firm/
Manufacturer		 DePuy Spine, Inc.
325 Paramount Dr
Raynham MA 02767-5199
For Additional Information Contact Anita Barnick
508-828-3583
Manufacturer Reason
for Recall		 Dilators and Holding Clip are being used for a secondary function of neuromonitoring, for which it is not 510(k) cleared.
FDA Determined
Cause 2		 Under Investigation by firm
Action DePuy Synthes sent an Urgent Voluntary Product Recall Notification letter dated July 30, 2013, to all affected consignees via Fed Ex overnight delivery. Consignees were informed that DePuy Spine, Inc. is voluntarily recalling all lots of the PIPELINE LS ACCESS SYSTEM Dilators (1 st, 2nd, 3rd, and 4th) and Holding Clip. They were asked to review inventory located at their facility and quarantine any products listed in this recall notice. Consignees were instructed to contact their local DePuy Synthes Spine Sales Consultant to return any inventory located within their facility. Consignees with questions were instructed to call 508-828-3583.
Quantity in Commerce 198 units
Distribution 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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