Outlook ES Safety Infusion System, Model 621-100ES, 621-200ES, 621-300ES, and 621-400ES B. Braun Medical Inc., 1601 Wall
FDA device recall Z-0007-2012 · posted 2011-10-03 · Terminated
Recall details
- Recalling firm
- B Braun Medical, Inc
- Reason for recall
- The Outlook ES Dose Guard Care Area can inadvertently be exited when the pump enters the KVO (Keep Vein Open) state. The same condition can occur when a sequence of HOLD-HOLD key strokes are performed on the pump key panel.
- Action taken
- The firm, B. Braun Medical Inc., sent an "URGENT: FIELD CORRECTION" letter dated September 8, 2011 to its customers. The letter described the product, problem and actions to be taken. The firm informed the customers that a B. Braun representative will be contact ing them to schedule a field software upgrade of the affected pumps. The customers were instructed to complete and return the FIELD CORRECTION INFORMATION FORM via mail using the enclosed envelop and contact B. Braun Customer Service for shipping instructions at 1-800-627-7867 if product is to be returned. Should you require any additional information, please do not hesitate to contact B. Braun Medical Inc., Technical Product Support at 1-800-627-7867 (800-627-PUMP).
- Root cause
- Software design
- Status
- Terminated
- Product code
- FRN
- Quantity affected
- 11,525 pumps
- Distribution
- Worldwide distribution: USA (nationwide) including states of: AR, CA, FL, GA, IA, IL, KS, KY, LA, MA, MI, MO, NC, NJ, NY, OH, PA, SC, TX, VA, WA, WI, and WV; and country of: Canada.
- Date initiated
- 2010-07-20
- Date posted
- 2011-10-03
- Date terminated
- 2015-01-07
- 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 |