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U.S. Department of Health and Human Services

Class 2 Device Recall Henora

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  Class 2 Device Recall Henora see related information
Date Initiated by Firm March 28, 2014
Date Posted July 07, 2014
Recall Status1 Terminated 3 on September 29, 2016
Recall Number Z-1996-2014
Recall Event ID 68552
510(K)Number K001599  
Product Classification Set, administration, intravascular - Product Code FPA
Product Henora REF: 70-4026-09V1 300psi I.V. Catheter Extension Set

Product Usage:
Catheter extension set for high pressure procedures.
Code Information Lot numbers 102131 and 110531.
Recalling Firm/
Manufacturer		 RGI Medical Manufacturing, Inc.
4637 NW 6th St
Gainesville FL 32609-0701
For Additional Information Contact Jesse Bishop
352-378-3633
Manufacturer Reason
for Recall		 Problem with low adhesion of the tubing to luer connection which may lead to a separation of the extension set while in use.
FDA Determined
Cause 2		 Process control
Action RGI Medical Manufacturing, Inc. phoned their direct account: Baxter Healthcare on February 28, 2014 and sent an Urgent: Device Recall letter dated March 21, 2014. The letter identified the affected product, problem and the actions to be taken. Contact 800-747-6870 to obtain instruction for returning the product to RGI
Quantity in Commerce 19,200 units.
Distribution US Nationwide Distribution in the states of AL, CA, DE, GA, IL, KY, MA, MD, ME, MI, MN, NJ, NM, NV, NY, OH, TN, TX, WA, and WI.
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 = FPA and Original Applicant = R-GROUP INTL.
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