The Patient Control Module (PCM) is used in conjunction with a Baxter infusor as a single use device for the control of
FDA device recall Z-1536-2015 · posted 2015-04-27 · Terminated
Recall details
- Recalling firm
- Baxter Healthcare Corp.
- Reason for recall
- Potential for device malfunction resulting in flow when the device should not be flowing
- Action taken
- Baxter Healthcare sent an Urgent Product Recall letter dated April 17, 2014, to the sole US consignee. The letter included instructions for the consignee to: 1) locate and remove all affected product; 2) contact Baxter's Center for Service to arrange for the return and credit; and 3) to complete and return the Customer Reply Form included with the recall notification. Questions about the recall can be answered by calling The Center for One Baxter at 800-422-9837.
- Root cause
- Process control
- Status
- Terminated
- Product code
- MEA
- Quantity affected
- 7,596 patient control modules
- Distribution
- Worldwide Distribution - US Distribution to the state of FL., and to the countries of : Belgium, Denmark, Germany, Italy, Japan, Norway, Poland, South Korea, Spain, Sweden and United Arab Emirates.
- Date initiated
- 2014-04-17
- Date posted
- 2015-04-27
- 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 |
|---|---|---|
| MODIFICATION TO: MULTIRATE INFUSOR SV )WITH AND WITHOUT PCM), MULTIRATE INFUSOR LV (WITH AND WITHOUT PCM) (K051253) | Baxter Healthcare Corp | 2005-07-15 |