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-2163-2013 · posted 2013-09-06 · Terminated

Recall details

Recalling firm

B Braun Medical, Inc.

Reason for recall

B. Braun Medical Inc. has become aware of an issue with the Outlook ES Safety Infusion System. The key panel may fail to function as intended if the underlying circuitry fails due to intermittent contact. This issue applies specifically to the HOLD button. If this occurs, the Door Processor (DP) will not receive the desired input from the user. This issue can be observed in pumps with key panels

Action taken

B Braun sent an URGENT: MEDICAL DEVICE FIELD CORRECTION letter dated October 24, 2012 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. Contact Customer Support at 1-800-627-7867 for questions regarding this notice.

Root cause

Component design/selection

Status

Terminated

Product code

FRN

Quantity affected

28,427

Distribution

Nationwide Distribution.

Date initiated

2012-10-24

Date posted

2013-09-06

Date terminated

2015-07-27

Location

Carrollton, TX