Baxter MiniCap with Povidone-Iodine Solution, 5C4466P, Baxter Healthcare Corporation. For dialysis.
FDA device recall Z-2074-2014 · posted 2014-07-17 · Terminated
Recall details
- Recalling firm
- Baxter Healthcare Corp.
- Reason for recall
- Inadequate iodine and packaging related defects.
- Action taken
- The firm notified their direct consignees on 06/17/2014 by letter requesting customers to locate and remove all affected product from their facility, and contact Baxter Healthcare Center for Service to arrange for return and credit.
- Root cause
- Packaging process control
- Status
- Terminated
- Product code
- KDI
- Quantity affected
- 585,360 units
- Distribution
- Distributed USA (nationwide) and Canada.
- Date initiated
- 2014-06-17
- Date posted
- 2014-07-17
- Date terminated
- 2015-04-03
- 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 |