Recall Z-0229-2007 ยท FEN Device, Cystometric, Hydraulic
Laborie Medical Technologies
Laborie Transducer Cartridge with Luer Lock Reference: DIS130
| Date | Dec 1, 2006 (initiated Oct 4, 2006) |
| Status | Terminated |
| 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.