Outlook ES pump is intended for use with B. Braun Medical Inc. Horizon Pump IV Sets. Used to regulate the flow of primar
FDA device recall Z-0051-2012 · posted 2011-10-18 · Terminated
Recall details
- Recalling firm
- B Braun Medical, Inc
- Reason for recall
- B Braun Outlook ES Safety Infusion System "Run" Light Emitting Diodes (LEDs) pumps stop infusing and a backup alarm sounds, but the "Run" LEDs advance as if the pumps were infusing.
- Action taken
- B. Braun Medical, Inc. sent an "URGENT: FIELD CORRECTION" letter dated September 7, 2011 to all affected customers. The letter describes the product, problem, and actions to be taken by the customers. A firm representative will contact all affected customers in order to schedule the field correction. The correction consists of revising the Door and Main Processor software, inspecting the main board, and replacing the board, if warranted. A Field Correction Information Form was included in the letter for customers to complete and return. Contact Technical Product Support at 1-800-627-7867 for questions regarding this notice.
- Root cause
- Software design
- Status
- Terminated
- Product code
- FRN
- Quantity affected
- 6321
- Distribution
- Nationwide Distribution
- Date initiated
- 2011-09-07
- Date posted
- 2011-10-18
- Date terminated
- 2015-05-04
- Location
- Carrollton, TX
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| HORIZON OUTLOOK WITH DOSECOM (K011975) | B.Braun Medical, Inc. | 2001-09-19 |
| HORIZON LIGHT (K994375) | B.Braun Medical, Inc. | 2000-03-08 |