Class II — Potential Health Hazard

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

Non-Vented Dispensing Pin with One-Way Valve and Luer Lock Ultrasite Recalled by B. Braun Medical, Inc. Due to BBMI recently identified a potential for a tear...

Date: April 14, 2016
Company: B. Braun Medical, Inc.
Status: Terminated
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

Non-Vented Dispensing Pin with One-Way Valve and Luer Lock Ultrasite Valve Product Usage: Used for aspiration of medication from inverted bags or semi-rigid containers. Interavenous delivery of transferred medication(Device is not intended for direct infusion)

Quantity: Approximately 11,000 units available in commercial channels

Why Was This Recalled?

BBMI recently identified a potential for a tear in the outer blister packaging on a limited number of units. The tears have been identified in the blister package paper, where the unit label writing is located.

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