Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

AMO ADMINISTRATION SET Recalled by B. Braun Medical, Inc. Due to Devices may leak as a result of a...

Date: September 26, 2023
Company: B. Braun Medical, Inc.
Status: Ongoing
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact B. Braun Medical, Inc. directly.

Affected Products

AMO ADMINISTRATION SET, Article No. 7A3817, REF OM2505191, for ophthalmologic use.

Quantity: 32,000

Why Was This Recalled?

Devices may leak as a result of a manufacturing issue. Leakage may result in a delay of therapy, increase risk of bloodstream infection (BSI), and may expose both patients and healthcare workers to hazardous medication. There is also the potential for life-threatening situations to occur requiring additional medical intervention.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About B. Braun Medical, Inc.

B. Braun Medical, Inc. has 216 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report