Recall Z-2555-2021— B. Braun Medical, Inc.
Class II · Terminated
Class II FDA medical device recall by B. Braun Medical, Inc., initiated 2021-08-10, terminated 2024-09-16. It names 3 FDA 510(k) clearances: K140311, K931377, K913661. Product: PUMP SET, 15 DR, 3 CARESITE, 127 in.single-use for use with the Outlook Safety Infusion System and/or Horizon NXT Pump for infusion of parenteral fluids Ref: 480239. 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
3 on FDA's record- K140311 — CARESITE LUER ACCESS DEVICE
- K931377 — SAFELINE SYSTEM IV ADMINISTRATION SETS & COMPONENT
- K913661 — MODIFIED VOLUMETRIC INFUSION PUMP
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
PUMP SET, 15 DR, 3 CARESITE, 127 in.single-use for use with the Outlook Safety Infusion System and/or Horizon NXT Pump for infusion of parenteral fluids Ref: 480239
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.