Recall Z-0045-04 ยท MSD Catheter, Hemodialysis, Implanted
Vasca, Inc.
LifeSite Hemodialysis Cannula Exchange Kit Part Number: LHCEK0000
| Date | Oct 15, 2003 (initiated Sep 22, 2003) |
| Status | Terminated |
| Reason | Outer kit mislabeled with an extended expiration date |
| Root cause | Other |
| Action | Vasca ,Inc. initiated their field action by letter on 9/22/03, advising accounts of the incorrect expiration date and requiring them to follow instructions to relabel the outer kit and the Exchange kit with the correct expiration date label provided. Vasca personnel will visit and verify the correction was completed. A Label Verification form will be completed by the Vasca personnel and returned to Vasca. |
| Quantity | 81 units |
| Distribution | AR, CA, FL, GA, IL, MI, MO, MA, OH, PA, TX, SC, WV |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K001633 | LIFESITE HEMODIALYSIS ACCESS SYSTEM/CANNULA EXCHANGE, MODEL LHAS14120 & LHCEK0000 Vasca, Inc., Aug 24, 2000 |