Baxter Integrated APD Set with Cassette 3-Prong, Sterile, nonpyrogenic fluid path. Product Usage: The recall device is i
FDA device recall Z-1039-2015 · posted 2015-02-02 · Terminated
Recall details
- Recalling firm
- Baxter Healthcare Corp.
- Reason for recall
- Baxter is issuing a recall for one lot of Integrated Automated Peritoneal Dialysis set with Cassette 3 prong due to complaints received for leakage.
- Action taken
- Baxter sent an Urgent Product Recall notification letter dated January 8, 2015 . The letter identified the affected product, problem and action to be taken. The recalling firm has asked the consignees to 1) locate and remove all affected product from their facilities, 2) contact Baxter to arrange for return and credit, and 3) complete the attached customer reply form and return it to Baxter. For questions call 800-422-9637.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- FKX
- Quantity affected
- 8,640 units
- Distribution
- US Nationwide Distribution in the states of FL, WI, AR, TN, TX, NC, MO, NM, NJ, CT, PA, NV, NY, CA, MI, WI, KS, and OH.
- Date initiated
- 2014-12-08
- Date posted
- 2015-02-02
- Date terminated
- 2015-10-28
- 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 |
|---|---|---|
| HOMECHOICE/HOMECHOICE PRO AUTOMATED PERSONAL CYCLER PERITONEAL DIALYSIS SYSTEM MODEL 5C4471, 5C8310, 5C4471R AND 5C8310R (K102936) | Baxter Healthcare Corp | 2011-03-30 |