FDA Medical Device Recalls (openFDA)
Vasca, Inc.: LifeSite Hemodialysis Cannula Exchange Kit Part Number: LHCEK0000
- Recall number
- Z-0045-04
- Recalling firm
- Vasca, Inc.
- Product
- LifeSite Hemodialysis Cannula Exchange Kit Part Number: LHCEK0000
- Status
- Terminated
- Initiated
- 2003-09-22
- Posted
- 2003-10-15
- Terminated
- 2003-11-14
- 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
- Lot, serial or model codes
- Lot Number: 30956
- 510(k) numbers
- ["K001633"]
- PMA numbers
- not on file
- Product code
- MSD
- Firm FEI
- 3000719967
- Firm city
- Tewksbury
- Firm state
- MA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28