Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp - Extra Short. 1 Unit. Sterile. Baxter Healthcare Corporat
FDA device recall Z-2246-2017 · posted 2017-06-02 · Terminated
Recall details
- Recalling firm
- Baxter Healthcare Corporation
- Reason for recall
- Connection issues between the PD transfer set catheter connector and an adapter may lead to leaks and contamination of the fluid pathway which may result in peritonitis.
- Action taken
- On April 28, 2014, firm sent an Urgent Product Recall to US customers via USPS 1st class mail. Baxter requested customers to locate and remove all affected product from their facility, and contact Baxter Healthcare Center for Service to arrange for return and credit. 100%, all non-respondents would be contacted by phone. All affected product would be destroyed. For general questions regarding this communication , contact The Center for One Baxter at 1-800-422-9837 , Monday through Friday, between the hours of 8:00AM and 5:00 PM Central Time.
- Root cause
- Unknown/Undetermined by firm
- Status
- Terminated
- Product code
- KDJ
- Quantity affected
- 6,048
- Distribution
- Nationwide Distribution and Internationally to Canada and Malaysia
- Date initiated
- 2014-04-28
- Date posted
- 2017-06-02
- Date terminated
- 2017-07-21
- 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 |
|---|---|---|
| EXTENDED LIFE CAPD TRANSFER SET 5C4444 (K882498) | Baxter Healthcare Corp | 1988-07-13 |