Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall RYM5001 InVisionPlus Neutral Displacement I.V. Connector

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
 Class 2 Device Recall RYM5001 InVisionPlus Neutral Displacement I.V. Connectorsee related information
Date Initiated by FirmMay 25, 2006
Date PostedDecember 30, 2006
Recall Status1 Terminated 3 on March 26, 2007
Recall NumberZ-0321-2007
Recall Event ID 36854
510(K)NumberK991653 
Product Classification I.V. Connectors - Product Code FPA
ProductRYM-5001 InVision-Plus Neutral Displacement I.V. Connector, packaged 100 units per box, 5 boxes per case (500 units/case); labeled as Sterile-Nonpyrogenic; assembled in Mexico for Rymed Technologies, Inc., Austin, TX.
Code Information Lots #500, 502, 503, 504 and 505.
Recalling Firm/
Manufacturer		 Rymed Technologies, Inc.
6000 W. William Cannon Drive
Bldg. B, Suite 300
Austin TX 78749
Manufacturer Reason
for Recall		Weld failures on IV connector (area of female luer and spike body)
FDA Determined
Cause 2		Other
ActionConsignees were notified by e-mail and/or phone on 05/25/06 regarding the recall. Distributors were asked to return product.
Quantity in Commerce28,479 units.
DistributionNationwide Recall
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = FPA
-
-