Recall Z-0161-2010 ยท MSD Catheter, Hemodialysis, Implanted
Medical Components, Inc dba MedComp
Medcomp, 10F Bioflex Tesio Kit with cutting trocar. Catalog number BFR-6CTT 5 per box. Hemodialysis catheter insertion kits.
| Date | Nov 10, 2009 (initiated Sep 2, 2009) |
| Status | Terminated |
| Reason | mislabeled as right are actually left |
| Root cause | Employee error |
| Action | Medcomp issued a "Product Alert" letter dated September 2, 2009 to all customers informing them of the problem and the need to return the product. For further information, contact Medcomp at 215-256-4201. |
| Quantity | 100 trays |
| Distribution | Worldwide Distribution -- United States (AR, FL, KS, LA, MO, PA, TN, and TX) and Austria. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K971925 | MEDCOMP BIO-FLEX CS CATHETER (CS100) Medical Components, Inc., Feb 23, 1998 |