| | Class 2 Device Recall RYM5000 InVisionPlus NEUTRAL I.V. Connector |  |
| Date Initiated by Firm | May 25, 2006 |
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| Date Posted | December 30, 2006 |
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| Recall Status1 |
Terminated 3 on March 26, 2007 |
| Recall Number | Z-0320-2007 |
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| Recall Event ID |
36854 |
| 510(K)Number | K991653 |
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| Product Classification |
I.V. Connectors - Product Code FPA
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| Product | RYM-5000 InVision-Plus NEUTRAL I.V. Connector, packaged 200 units per box, 5 boxes per case (1000 units/case); labeled as Sterile-Nonpyrogenic; assembled in Mexico for Rymed Technologies, Inc., Austin, TX. |
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| Code Information |
Lot #405. |
Recalling Firm/
Manufacturer |
Rymed Technologies, Inc.
6000 W. William Cannon Drive
Bldg. B, Suite 300
Austin TX 78749
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Manufacturer Reason
for Recall | Weld failures on IV connector (area of female luer and spike body) |
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FDA Determined
Cause 2 | Other |
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| Action | Consignees were notified by e-mail and/or phone on 05/25/06 regarding the recall. Distributors were asked to return product. |
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| Quantity in Commerce | 16,000 units. |
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| Distribution | Nationwide Recall |
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| Total Product Life Cycle | TPLC Device Report |
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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.
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| 510(K) Database | 510(K)s with Product Code = FPA
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