Recall Z-1796-2008
Mentor Texas, Inc · initiated April 21, 2008
Product
Psi-Tec Syringe Pump Infiltration Tubing, 10'; 10/box; Part Number PT-INF-T; distributed by Mentor Texas, LP, Irving, TX 75038.
Codes / lots: Lot #: IN4900, IN5906, IN5916, IN5922, IN5928, IN5934, IN5942, IN5950, IN5956, IN5970, IN5974, IN5984, IN6986, IN6990, IN6996, IN6998, IN6108, IN6114, IN6126, IN6142, IN6158, IN6168, IN7176, IN7196, IN7202, IN7240, IN7268 and IN8292.
Reason for recall
During packaging integrity validation, it was found that various product packages could fail, compromising the sterility of the devices.
FDA-determined cause: Other
Action taken
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.
Details
- Recall number
- Z-1796-2008
- Initiated
- April 21, 2008
- Posted by FDA
- September 5, 2008
- Terminated
- July 29, 2010
- Product code
- FPK – Tubing, Fluid Delivery
- Quantity
- 1,151 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…
- Recalling firm
- Mentor Texas, Inc, Irving, TX
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-1790-2008 | Psi-Tec Tubing, 12'; 10/box; Part Number PT-5558; distributed by Mentor Texas, LP…During packaging integrity validation, it was found that various product packages could fail, compromising… | 04/21/2008Terminated |
| Z-1791-2008 | Autofuse Tubing, DIS SI; Part Number AFTU-DS; distributed by Mentor Texas, LP, Irving…During packaging integrity validation, it was found that various product packages could fail, compromising… | 04/21/2008Terminated |
| Z-1792-2008 | Hi-Vac Tubing, 8'; 10/box; Part Number B-5558; distributed by Mentor Texas, LP, Irving…During packaging integrity validation, it was found that various product packages could fail, compromising… | 04/21/2008Terminated |
| Z-1793-2008 | Lamis Tubing Set, 9'; 10/box; Part Number LAM-TUBING; distributed by Mentor Texas, LP…During packaging integrity validation, it was found that various product packages could fail, compromising… | 04/21/2008Terminated |
| Z-1794-2008 | Y Tubing Set, 9'; 10/box; Part Number LAM-Y; distributed by Mentor Texas, LP, Irving, TX…During packaging integrity validation, it was found that various product packages could fail, compromising… | 04/21/2008Terminated |
| Z-1795-2008 | Irrigation Tubing, 25'; Part Number 5120-25; distributed by Mentor Texas, LP, Irving, TX…During packaging integrity validation, it was found that various product packages could fail, compromising… | 04/21/2008Terminated |
| Z-1797-2008 | Contour Genesis Infiltration Tubing, 13'; Part Number CG-INF-T; distributed by Mentor…During packaging integrity validation, it was found that various product packages could fail, compromising… | 04/21/2008Terminated |
| Z-1798-2008 | Contour Genesis Inf/IR Tubing; Part Number CG-UT; distributed by Mentor Texas, LP…During packaging integrity validation, it was found that various product packages could fail, compromising… | 04/21/2008Terminated |
| Z-1799-2008 | Contour Genesis Aspiration Tubing, 12'; Part Number CG-PT-5558; distributed by Mentor…During packaging integrity validation, it was found that various product packages could fail, compromising… | 04/21/2008Terminated |