B. Braun Medical, Inc.: Outlook¿ Pump 15 Drop 0.2 Micron Filtered IV Set with 2 CARESITE¿ Y-Sites: single-use for use with the Outlook Safety Infusion System and/or Horizon NXT Pump for infusion of pa

Is my product affected?

Outlook¿ Pump 15 Drop 0.2 Micron Filtered IV Set with 2 CARESITE¿ Y-Sites: single-use for use with the Outlook Safety Infusion System and/or Horizon NXT Pump for infusion of parenteral fluids Ref: 354214

• UPC 04046964182235

Check against the official notice below — it lists the full affected range.

What happened

B. Braun Medical, Inc. is recalling 44,866 units of Outlook Pump 15 Drop 0.2 Micron Filtered IV Set with 2 CARESITE Y-Sites worldwide, including nationwide distribution in the US and Canada. These single-use IV sets are designed for use with the Outlook Safety Infusion System and/or Horizon NXT Pump. The recall affects specific lot codes: 0061752471, 0061756801, 0061757861, 0061766196, and 0061777798 (Device Identifier: 04046964182235).

The recalled IV sets may leak within the cassette portion of the pump sets, which could delay medication administration, result in under-delivery or incomplete dosing, and potentially cause bloodstream infections. The source document does not specify a remedy or corrective action that consumers should take.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

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.

Details from the source

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. Distribution: Worldwide distribution - US Nationwide distribution and the country of Canada. Quantity: 44,866 units Lot/code info: Lot Code: 0061752471 0061756801 0061757861 0061766196 0061777798 DI: 04046964182235

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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