Baxter HomeChoice Automated PD Set with Lineo Connector, 4-prong, product codes R5C4479Q (English) and N5C4479Q (dual En
FDA device recall Z-0340-04 · posted 2004-07-20 · Terminated
Recall details
- Recalling firm
- Baxter Healthcare Corp.
- Reason for recall
- Reports of loosening of the connections and disconnection of the device.
- Action taken
- Baxter sent recall letters dated 12/5/03 to the accounts in the United Kingdom and recall letters dated 12/8/03 to the accounts in Canada, informing them of the reports of loosening of the connections and disconnection of the device, and requesting that they discontinue use of product codes involved and revert the enrolled patients back to their traditional connection system.
- Root cause
- Other
- Status
- Terminated
- Product code
- KGZ
- Quantity affected
- 10,030 units
- Distribution
- Canada and the United Kingdom
- Date initiated
- 2003-12-05
- Date posted
- 2004-07-20
- Date terminated
- 2004-07-30
- Location
- Round Lake, IL
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| HOMECHOICE APD SET WITH LINEO CONNECTOR, MODELS 5C4469Q, 5C4468Q, 5C4531Q, 5C8302Q, 5C4599Q (K031676) | Baxter Healthcare Corp | 2003-11-20 |