Z-0319-2007

RYM-5000 InVision-Plus Neutral Displacement I.V. Connector, packaged 200 units per box, 5 boxes per case...

Name: Z-0319-2007 RYM-5000 InVision-Plus Neutral Displacement I.V. Connector, packaged 200 units per box, 5 boxes per case...
Creator: Rymed Technologies, Inc.
Published: 2006-05-25
License: https://open.fda.gov/license/

RyMed Technologies, LLC / initiated 2006-05-25 / Terminated / root cause: manufacturing process

FDA source

Rymed Technologies, Inc. began a recall of RYM-5000 InVision-Plus Neutral Displacement I.V. Connector, packaged 200 units per box, 5 boxes per case (1000 units/case); labeled as Sterile-Nonpyrogenic... on 2006-05-25. The reason FDA records is "Weld failures on IV connector (area of female luer and spike body)". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0319-2007
Status: Terminated
Initiated: 2006-05-25
Posted: 2006-12-30
Terminated: 2007-03-26
Recalling firm: RyMed Technologies, LLC
Product: RYM-5000 InVision-Plus Neutral Displacement 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.
Product code: FPA Set, Administration, Intravascular
Reason for recall: Weld failures on IV connector (area of female luer and spike body)
Root cause tag: manufacturing process
FDA root cause: Other
Action: Consignees were notified by e-mail and/or phone on 05/25/06 regarding the recall. Distributors were asked to return product.
Quantity in commerce: 34,849 units.
Distribution: Nationwide Recall
Product codes and lots: Lots #400, 401, and 402.

Product code FPA

K991653Class IIInvision-Plus Injection Port Connector SystemRymed Technologies, Inc. / cleared 1999-06-24

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)