Z-0229-2007

Laborie Transducer Cartridge with Luer Lock Reference: DIS130

Name: Z-0229-2007 Laborie Transducer Cartridge with Luer Lock Reference: DIS130
Creator: Laborie Medical Technologies
Published: 2006-10-04
License: https://open.fda.gov/license/

Abbott Medical / initiated 2006-10-04 / Terminated / root cause: labeling and UDI

FDA source

Laborie Medical Technologies began a recall of Laborie Transducer Cartridge with Luer Lock Reference: DIS130 on 2006-10-04. The reason FDA records is "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0229-2007
Status: Terminated
Initiated: 2006-10-04
Posted: 2006-12-01
Terminated: 2007-05-18
Recalling firm: Abbott Medical
Product: Laborie Transducer Cartridge with Luer Lock Reference: DIS130
Product code: FEN Device, Cystometric, Hydraulic
Reason for recall: 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 tag: labeling and UDI
FDA 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 in commerce: 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
Product codes and lots: Lot Numbers: 36G20M41 and 36H03M005

Product code FEN

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)