Baxter, MiniCap with Povidone-Iodine solution, 5C4466P. For dialysis.
FDA device recall Z-1945-2014 · posted 2014-06-30 · Terminated
Recall details
- Recalling firm
- Baxter Healthcare Corp.
- Reason for recall
- the white printed paper layer on the pouch packaging may not be fully adhered to the pouch foil layer. The upper paper layer may serve as a protective barrier and help support overall packaging.
- Action taken
- An Urgent Product Recall notification was mailed via U.S.P.S. first-class mail to facilities, (dialysis centers and distributors) on July 8, 2013 and mailed by first-class mail to home patients on July 11, 2013.
- Root cause
- Packaging change control
- Status
- Terminated
- Product code
- KDI
- Quantity affected
- 20,940 units
- Distribution
- Distributed in the states of AR, TN MO, KS, TX, MS, and AL.
- Date initiated
- 2013-07-08
- Date posted
- 2014-06-30
- Date terminated
- 2014-06-30
- Location
- Deerfield, IL
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| DISCONNECT CAPS PRODUCT CODES 5C4212 AND 5C4466 (K895631) | Baxter Healthcare Corp | 1990-01-29 |