Class 2 Device Recall RK Epidural Needle

• Date Initiated by Firm: April 22, 2016
• Create Date: October 31, 2016
• Recall Status: Terminated on June 14, 2018
• Recall Number: Z-0086-2017
• Recall Event ID: 74018
• 510(K)Number: K072005
• Product Classification: Needle, conduction, anesthetic (w/wo introducer) - Product Code BSP
• Product: 15 g R.K. Epidural Needle (TW), Catalog #/REF #100-1415 Intended for the epidural placement, directly or through an epidural catheter, of anesthetic agents to elicit regional anesthesia
• Code Information: 1) Spectra Lot# GC091702 (Epimed manufacturing lot # 2801501, Sterile Lot # 12157181) 2) Spectra Lot# GC101871 (Epimed manufacturing lot # 3211503, Sterile Lot # 12157445) 3) Spectra Lot# GC101897 (Epimed manufacturing lot # 3161501, Sterile Lot # 12157325)
• FEI Number: 1316297
• Recalling Firm/ Manufacturer: Epimed International, Inc.; 141 Sal Landrio Dr; Crossroads Business Park; Johnstown NY 12095-3835
• For Additional Information Contact: Bobbi Harrington; 518-725-0209
• Manufacturer Reason for Recall: There is a possibility that the needles may have the potential to skive a catheters outer coating. If this were to occur, there exists the risk that a portion of the catheter could remain in the patient, which may require otherwise unnecessary medical invention.
• FDA Determined Cause: Employee error
• Action: On April 22, 2016, Epimed sent an Urgent Medical Device Recall notices and Recall Return Response Forms to their customers via courier service. Customers were advised to examine all inventory and quarantine product subject to recall immediately. Once the product has been quarantined, please complete and return the enclosed response form as soon as possible by fax to: 518-725-0207, Attn: Quality Assurance. In addition, if you find any product that corresponds to the lot numbers given, please contact the Customer Service Department so that Epimed can arrange for replacement/credit (518-725-0209 or 518-514-1891). Further questions, please call (518) 725-0209.
• Quantity in Commerce: 576 units
• Distribution: US Distribution to the states of : AL, AK, FL, IN, TN & TX
• 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.

• 510(K) Database: 510(K)s with Product Code = BSP