The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-0425-2014·Announced 2013-12-04

B. Braun Recalls addEASE Binary Connectors Due to Solution Leakage

B. Braun Medical is recalling 4,000 addEASE Binary Connectors because a misaligned needle may cause solution to leak from the bag stopper.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall is classified as FDA Class II. The hazard involves potential leakage of medical solution due to a mechanical defect, which poses a risk of harm to patients, but the source text does not report specific injuries or hospitalizations.

Plain-English summary

B. Braun Medical, Inc. is recalling 4,000 units of the 13mm addEASE(TM) Binary Connector with 17 Ga. Needle for use with PAB(R) Containers, product code BC1300. The product is intended for fluid transfer between a Partial Additive Bag (PAB(R)) container and a drug vial. The recall affects lot number 61286479, which was distributed nationwide.

The recall is being issued due to possible solution leakage at the interface of the addEASE(TM) Binary Connector and the PAB(R) bag. An extensive root cause investigation determined that the leakage is the result of a misaligned cannula (needle) on the connector. This misalignment allows the needle to pierce the PAB(R) bag stopper in a way that may result in leakage.

Healthcare facilities and consumers should stop using the affected product immediately. Users should contact B. Braun Medical, Inc. for instructions on how to return the product or obtain a replacement.

The recalled product

Product
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.
Manufacturer
B. Braun Medical, Inc.
Category
Medical Device — Fluid Transfer Connectors
Hazard
Affected units
4,000

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

  • Material BC1300
  • Lot number 61286479.

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 2 recalled by B. Braun Medical, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

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