Z-1797-2008

Contour Genesis Infiltration Tubing, 13'; Part Number CG-INF-T; distributed by Mentor Texas, LP, Irving, TX...

Name: Z-1797-2008 Contour Genesis Infiltration Tubing, 13'; Part Number CG-INF-T; distributed by Mentor Texas, LP, Irving, TX...
Creator: Mentor Texas, Inc
Published: 2008-04-21
License: https://open.fda.gov/license/

Mentor / initiated 2008-04-21 / Terminated / root cause: packaging

FDA source

Mentor Texas, Inc began a recall of Contour Genesis Infiltration Tubing, 13'; Part Number CG-INF-T; distributed by Mentor Texas, LP, Irving, TX 75038 on 2008-04-21. The reason FDA records is "During packaging integrity validation, it was found that various product packages could fail, compromising the sterility of the devices". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-1797-2008
Status: Terminated
Initiated: 2008-04-21
Posted: 2008-09-05
Terminated: 2010-07-29
Recalling firm: Mentor
Product: Contour Genesis Infiltration Tubing, 13'; Part Number CG-INF-T; distributed by Mentor Texas, LP, Irving, TX 75038.
Product code: FPK Tubing, Fluid Delivery
Reason for recall: During packaging integrity validation, it was found that various product packages could fail, compromising the sterility of the devices.
Root cause tag: packaging
FDA root cause: Other
Action: A Customer Letter was issued to all consignees by the firm on 4/21/2008. Consignees were informed that a recent testing of these products discovered a potential defect in the packaging configuration, which could result in a loss of package integrity. Consignees were asked to review inventory and dispose of product and contact firm for credit.
Quantity in commerce: 4,321 boxes.
Distribution: Class II Recall - Worldwide Distribution ---- including USA, Puerto Rico and countries of Argentina, Austria, Bermuda, Brazil, Canada, China, Costa Rica, Cyprus, Denmark, England, Germany, Greece, Guatemala, India, Italy, Italy, Japan, Kuwait, Lebanon, Malta, Mexico, Morocco, Pakistan, Panama, Paraguay, Portugal, Slovak Republic, Slovenia, Spain, South Africa, South Korea, Switzerland, Taiwan, Thailand, Turkey and Venezuela.
Product codes and lots: Lot #: CI4900, CI5906, CI5912, CI5920, CI5929, CI5924, CI5930, CI5932, CI5938, CI5940, CI5942, CI5944, CI5948, CI5950, CI5952, CI5958, CI5970, CI5976, CI6986, CI6996, CI6998, CI6108, CI6114, CI6124, CI6126, CI6134, CI6140, CI6172, CI7178, CI7182, CI7192, CI7200, CI7202, CI7204, CI7216, CI7218, CI7228, CI7246, CI7248, CI7268, CI7280, CI8292, CI8298, CI8308 and CI8312.

Product code FPK

The FDA recall record names no cleared device, and no clearance has been matched to it.

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)