FDA Medical Device Recalls (openFDA)
Laborie Medical Technologies: Laborie Transducer Cartridge with Luer Lock Reference: DIS130
- Recall number
- Z-0229-2007
- Recalling firm
- Laborie Medical Technologies
- Product
- Laborie Transducer Cartridge with Luer Lock Reference: DIS130
- Status
- Terminated
- Initiated
- 2006-10-04
- Posted
- 2006-12-01
- Terminated
- 2007-05-18
- Reason
- Mislabeling: Product labeled with incorrect "Use Before" date and pouch labels missing lot number. (Incorrect dates-2006/07 or 2006/08; correct Use by dates-2009/08 for Lot 36H03M005 and 2009/07 for Lot 36G20M041
- Root cause
- Other
- Action
- Laborie Medical telephoned Customers on 10/4-5/06 and advised they were sent product DIS130 with Lot # 36G20M41 and or #36H03M005 were incorrectly labeled with expiration date and lacked lot number on the pouch label. Directions were provided for product return.
- Quantity
- 2,625 units
- Distribution
- Worldwide-USA including states of AR, CA, FL, KY, MA, NY, OK, TX and Country of Canada: Laborie Medical Montreal, Canada Laborie Medical Toronto, Canada
- Lot, serial or model codes
- Lot Numbers: 36G20M41 and 36H03M005
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- FEN
- Firm FEI
- 1526863
- Firm city
- Williston
- Firm state
- VT
- 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