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U.S. Department of Health and Human Services

Class 2 Device Recall RK Epidural Needle

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  Class 2 Device Recall RK Epidural Needle see related information
Date Initiated by Firm April 22, 2016
Create Date October 31, 2016
Recall Status1 Terminated 3 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)
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 2		 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 and Original Applicant = EPIMED INTERNATIONAL
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