Recall Z-1711-2009 ยท EXQ Cystometer, Electrical Recording
Laborie Medical Technologies Cor
Laborie Medical Technologies Urodynamic Catheters, Twin Lumen 6 Fr , 40cm For Cystometry. Catalog Number: CAT-206.
| Date | Jul 21, 2009 (initiated Apr 9, 2009) |
| Status | Terminated |
| Reason | Laborie Medical Technologies reports that there was a mix up in the labeling and packaging of their Urodynamic Catheters. There were 8Fr catheters mixed inside the 6Fr catheter packages. |
| Root cause | Packaging process control |
| Action | Laborie Medical Technologies notified customers by telephone/email beginning April 10, 2009 advising them of the mislabelled product. For further questions, contact Laborie Medical Technologies at 1-800-522-6743. |
| Quantity | 28 boxes (10's) |
| Distribution | Nationwide Distribution -- CA, GA, IL, KS, MD, PA, OH, OK, UT and WA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.