FDA Medical Device Recalls (openFDA)
Mentor Texas, Inc: Irrigation Tubing, 25'; Part Number 5120-25; distributed by Mentor Texas, LP, Irving, TX 75038.
- Recall number
- Z-1795-2008
- Recalling firm
- Mentor Texas, Inc
- Product
- Irrigation Tubing, 25'; Part Number 5120-25; distributed by Mentor Texas, LP, Irving, TX 75038.
- Status
- Terminated
- Initiated
- 2008-04-21
- Posted
- 2008-09-05
- Terminated
- 2010-07-29
- Reason
- During packaging integrity validation, it was found that various product packages could fail, compromising the sterility of the devices.
- 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
- 1,436 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.
- Lot, serial or model codes
- Lot #: LS4904, LS4904, LS5908, LS5916, LS5922, LS5928, LS5934, LS5942, LS5956, LS5970, LS5974, LS5976, LS6988, LS6994, LS6998, LS6108, LS6114, LS6124, LS6138, LS6148, LS6154, LS6168, LS7176, LS7178, LS7180, LS7184, LS7190, LS7202, LS7218, LS7232, LS7244, LS7258, LS7280 and LS8304.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- FPK
- Firm FEI
- 1000118360
- Firm city
- Irving
- Firm state
- TX
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28