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U.S. Department of Health and Human Services

Class 2 Device Recall Integra Long Epidural Steroid Injection Needle (Tuohy Needle)

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  Class 2 Device Recall Integra Long Epidural Steroid Injection Needle (Tuohy Needle) see related information
Date Initiated by Firm March 30, 2015
Date Posted April 29, 2015
Recall Status1 Terminated 3 on June 24, 2015
Recall Number Z-1544-2015
Recall Event ID 70873
510(K)Number K854816  
Product Classification Needle, conduction, anesthetic (w/wo introducer) - Product Code BSP
Product Integra Long Epidural Steroid Injection Needle (Tuohy Needle), 18 Gauge x 5 inch Removable Wing, Metal Stylet, Calibrations (10BX), Catalogue No. PITRW1850.

Used to administer steroid medication in the epidural space.
Code Information Lot No. W1412086, Exp DEC-2017.
Recalling Firm/
Manufacturer		 Integra LifeSciences Corp. d.b.a. Integra Pain Management
3498 West 2400 South #1050
Salt Lake City UT 84119
For Additional Information Contact Mr. David E. Gronostajski
609-936-6822
Manufacturer Reason
for Recall		 A single lot of 18 Gauge, 3.5 inch Tuohy Needles were incorrectly packaged and labeled as 18 Gauge, 5 inch needles.
FDA Determined
Cause 2		 Employee error
Action US Consignees were notified by an Urgent: Voluntary Medical Device Recall letter on 3/30/15 delivered by traceable courier service. The letter identified the affected product and explained the reason for the recall. Customers were asked to review their inventory, identify affected products, and immediately stop use and remove them from service. Customers are to complete the attached form and return via mail or fax. Upon receipt of the form, Customer Service will provide an RMA number and directions for returning the affected products to the firm. Customers should contact Customer Service at 1-800-241-2210 with any questions regarding the instructions.
Quantity in Commerce 90 Tuohy needles (9 cases of 10 each)
Distribution Nationwide Distribution.
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 = REGANES, INC.
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