LifeSite Hemodialysis Cannula Exchange Kit Part Number: LHCEK0000
FDA Recall Z-0045-04 · Posted 2003-10-15
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Recalling FirmVasca, Inc.
Recall StatusTerminated
Product CodeMSD
Date Initiated2003-09-22
Date Terminated2003-11-14
Product Quantity81 units
Reason for Recall
Outer kit mislabeled with an extended expiration date
Firm 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.
Root Cause
Other
Distribution Pattern
AR, CA, FL, GA, IL, MI, MO, MA, OH, PA, TX, SC, WV
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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