Recall Z-2554-2021— B. Braun Medical, Inc.

Name: FDA recall Z-2554-2021
Creator: U.S. Food and Drug Administration
Published: 2021-08-10

Class II · Terminated

Class II FDA medical device recall by B. Braun Medical, Inc., initiated 2021-08-10, terminated 2024-09-16. It names 2 FDA 510(k) clearances: K140311, K913661. Product: OUTLOOK PUMP IV SET, 134 IN.-single-use for use with the Outlook Safety Infusion System and/or Horizon NXT Pump for infusion of parenteral fluids Ref: 477009. Reason: Leakage of the pump set within the cassette portion of the pump sets, potential for delays in administration of medications, under-delivery or incomplete dosing and bloodstream infections..

Recalling firm: B. Braun Medical, Inc.
Classification: Class II
Status: Terminated
Initiated: 2021-08-10
Terminated: 2024-09-16
Firm location: Allentown, PA, United States

510(k) clearances named in this recall

2 on FDA's record

K140311 — CARESITE LUER ACCESS DEVICEB.Braun Medical, Inc.·cleared 2014-05-07
K913661 — MODIFIED VOLUMETRIC INFUSION PUMPMcgaw, Inc.·cleared 1991-12-18

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

OUTLOOK PUMP IV SET, 134 IN.-single-use for use with the Outlook Safety Infusion System and/or Horizon NXT Pump for infusion of parenteral fluids Ref: 477009

Reason for recall

Leakage of the pump set within the cassette portion of the pump sets, potential for delays in administration of medications, under-delivery or incomplete dosing and bloodstream infections.

Data sourced from openFDA. This site is unofficial and independent of the FDA.