LifeSite Hemodialysis Cannula Exchange Kit Part Number: LHCEK0000
FDA device recall Z-0045-04 · posted 2003-10-15 · Terminated
Recall details
- Recalling firm
- Vasca, Inc.
- Reason for recall
- Outer kit mislabeled with an extended expiration date
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- MSD
- Quantity affected
- 81 units
- Distribution
- AR, CA, FL, GA, IL, MI, MO, MA, OH, PA, TX, SC, WV
- Date initiated
- 2003-09-22
- Date posted
- 2003-10-15
- Date terminated
- 2003-11-14
- Location
- Tewksbury, MA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| LIFESITE HEMODIALYSIS ACCESS SYSTEM/CANNULA EXCHANGE, MODEL LHAS14120 & LHCEK0000 (K001633) | Vasca, Inc. | 2000-08-24 |