Baxter CAPD Solution Transfer Set for use with UV-Flash Germicidal Exchange Device, 1.2 m (48''); a sterile set consisti
FDA device recall Z-0301-05 · posted 2004-12-09 · Terminated
Recall details
- Recalling firm
- Baxter Healthcare Renal Div
- Reason for recall
- Disconnection of the tubing at the clamp level of the UV Flash Transfer Set.
- Action taken
- Recall by letter dated 11/05/04. The customers were instructed to stop using this lot of product, return any stocks of the lot back to Baxter, and that replacement of the patient''s set be completed at the dialysis center.
- Root cause
- Other
- Status
- Terminated
- Product code
- KDJ
- Quantity affected
- 1,152 sets
- Distribution
- The entire lot was distributed overseas to Belgium, Sweden, Norway, the United Kingdom, Germany and France.
- Date initiated
- 2004-11-05
- Date posted
- 2004-12-09
- Date terminated
- 2006-05-16
- Location
- Park, IL
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| CAPD ULTRAVIOLET(U.V.) GERMICIDAL EXCHANGE DEV SYS (K883239) | Baxter Healthcare Corp | 1988-10-21 |