Z-0045-04

LifeSite Hemodialysis Cannula Exchange Kit Part Number: LHCEK0000

Name: Z-0045-04 LifeSite Hemodialysis Cannula Exchange Kit Part Number: LHCEK0000
Creator: Vasca, Inc.
Published: 2003-09-22
License: https://open.fda.gov/license/

Vasca, Inc. / initiated 2003-09-22 / Terminated / root cause: labeling and UDI

FDA source

Vasca, Inc. began a recall of LifeSite Hemodialysis Cannula Exchange Kit Part Number: LHCEK0000 on 2003-09-22. The reason FDA records is "Outer kit mislabeled with an extended expiration date". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0045-04
Status: Terminated
Initiated: 2003-09-22
Posted: 2003-10-15
Terminated: 2003-11-14
Recalling firm: Vasca, Inc.
Product: LifeSite Hemodialysis Cannula Exchange Kit Part Number: LHCEK0000
Product code: MSD Catheter, Hemodialysis, Implanted
Reason for recall: Outer kit mislabeled with an extended expiration date
Root cause tag: labeling and UDI
FDA 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 in commerce: 81 units
Distribution: AR, CA, FL, GA, IL, MI, MO, MA, OH, PA, TX, SC, WV
Product codes and lots: Lot Number: 30956

Product code MSD

K001633Class IILifesite Hemodialysis Access System/cannula Exchange, Model Lhas14120 & Lhcek0000Vasca, Inc. / cleared 2000-08-24

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)