Baxter, MiniCap with Povidone-Iodine solution, 5C4466P, Baxter Healthcare Corporation. For dialysis. Intended to isolate
FDA device recall Z-1565-2013 · posted 2013-06-21 · Terminated
Recall details
- Recalling firm
- Baxter Healthcare Corp.
- Reason for recall
- leaking pouches
- Action taken
- The firm, Baxter Healthcare Corporation sent an "URGENT PRODUCT RECALL" letter dated May 21, 2013 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. For general questions regarding this communication, contact The Center for One Baxter at 1-800-422-9837.
- Root cause
- Packaging change control
- Status
- Terminated
- Product code
- KDI
- Quantity affected
- 629,280 units
- Distribution
- Nationwide Distribution.
- Date initiated
- 2013-05-21
- Date posted
- 2013-06-21
- Date terminated
- 2016-07-14
- 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 |