Laborie Transducer Cartridge with Luer Lock Reference: DIS130
FDA Recall Z-0229-2007 · Posted 2006-12-01
Recalling FirmLaborie Medical Technologies
Recall StatusTerminated
Product CodeFEN
Date Initiated2006-10-04
Date Terminated2007-05-18
Product Quantity2,625 units
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
Firm 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.
Root Cause
Other
Distribution Pattern
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
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.