RecallDepth

LifeSite Hemodialysis Cannula Exchange Kit Part Number: LHCEK0000

Company
Vasca, Inc.
Recall Initiated
September 22, 2003
Posted
October 15, 2003
Terminated
November 14, 2003
Recall Number
Z-0045-04
Quantity
81 units
Firm Location
Tewksbury, MA

Reason for Recall

Outer kit mislabeled with an extended expiration date

Distribution

AR, CA, FL, GA, IL, MI, MO, MA, OH, PA, TX, SC, WV

Lot / Code Info

Lot Number: 30956

Root Cause

Other

Action Taken

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.