Class 3 Device Recall VASCA

• Date Initiated by Firm: September 22, 2003
• Date Posted: October 15, 2003
• Recall Status: Terminated on November 14, 2003
• Recall Number: Z-0045-04
• Recall Event ID: 27321
• 510(K)Number: K001633
• Product Classification: Catheter, Hemodialysis, Implanted - Product Code MSD
• Product: LifeSite Hemodialysis Cannula Exchange Kit Part Number: LHCEK0000
• Code Information: Lot Number: 30956
• FEI Number: 3000719967
• Recalling Firm/ Manufacturer: Vasca, Inc.; 3 Highwood Drive; Tewksbury MA 01876
• For Additional Information Contact: Nama Doddi; 978-863-4402
• Manufacturer Reason for Recall: Outer kit mislabeled with an extended expiration date
• FDA Determined 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 in Commerce: 81 units
• Distribution: AR, CA, FL, GA, IL, MI, MO, MA, OH, PA, TX, SC, WV
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 �7.55.

• 510(K) Database: 510(K)s with Product Code = MSD