Class II — Potential Health Hazard

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

13mm addEASE(TM) Binary Connector with 17 Ga. Needle for use Recalled by B. Braun Medical, Inc. Due to Possible solution leakage at the interface of the...

Date: April 4, 2013
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

13mm addEASE(TM) Binary Connector with 17 Ga. Needle for use with PAB(R) Containers, BC1300 Product is intended for fluid transfer between a Partial Additive Bag (PAB(R)) container and a drug vial.

Quantity: 4,000 units

Why Was This Recalled?

Possible solution leakage at the interface of the addEASE(TM) Binary Connector (Product Codes BC2000 and BC1300) and the PAB(R) bag. Based on extensive root cause investigation, it has been determined that the leakage is the result of a misaligned cannula (needle) on the addEASE(TM) Binary Connector, which pierces the PAB(R) bag stopper to access the solution. The misaligned cannula may result i

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.

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