The Plum A+ Infusion Systems are a multipurpose family of devices that provides precise delivery of multiple therapies a
FDA device recall Z-2680-2017 · posted 2017-07-07 · Terminated
Recall details
- Recalling firm
- ICU
- Reason for recall
- A possible interruption of therapy when an E321 error code occurs while using the infuser, which is caused by battery issues.
- Action taken
- Hospira has contracted with Stericycle Inc., in Indianapolis, IN to send letters and a reply form to Hospira customers. Receipt of the letters will be confirmed by UPS tracking. Customers will be requested to return a reply form to Stericycle indicating they have received the letter, and notified their customers. The customers will also be asked to supply the number of Plum A+ infusers at their facility.
- Root cause
- Other
- Status
- Terminated
- Product code
- FRN
- Quantity affected
- 7848 units
- Distribution
- Nationwide, Worldwide
- Date initiated
- 2013-02-01
- Date posted
- 2017-07-07
- Date terminated
- 2018-05-31
- Location
- Lake Forest, IL
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| HOSPIRA PLUM A+ INFUSION PUMP, MODEL 12391 (K070398) | Hospira, Inc. | 2007-04-24 |