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-2175-2013 · posted 2013-09-10 · Terminated
Recall details
- Recalling firm
- B Braun Medical, Inc.
- Reason for recall
- B. Braun Medical Inc. is informing our customers of a field correction previously performed to address the loss of the drug library in the Outlook Pump Models 620-100 and 620-200. This could have occurred after periods of lost DC (battery) power or out of tolerance low power. This could have led to a delay in therapy, or to delivery of an over or under-dose of a therapy if the user was to rely on
- Action taken
- The firm, B. Braun Medical Inc., sent an "URGENT: MEDICAL DEVICE FIELD CORRECTION" letter dated December 05, 2012 to its customers. The letter describes the product, problem and actions taken. The firm finished performing "field upgrades" on March 20, 2010 for this issue. Should you require any additional information, please do not hesitate to contact B. Braun Medical Inc., Infusion Systems Customer Service at 1-800-627-7867 (627-PUMP).
- Root cause
- Component design/selection
- Status
- Terminated
- Product code
- FRN
- Quantity affected
- 14,161
- Distribution
- Worldwide Disribution: USA (nationwide) and country of: Canada.
- Date initiated
- 2012-12-05
- Date posted
- 2013-09-10
- Date terminated
- 2014-10-24
- Location
- Carrollton, TX
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| HORIZON LIGHT (K994375) | B.Braun Medical, Inc. | 2000-03-08 |