The Recall Desk
HighFDA (Devices)·Z-0424-2014·Announced 2013-12-04

B. Braun addEASE Binary Connector Recalled for Possible Solution Leakage

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

What this means for you

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 and involves a medical device defect that poses a risk of harm (solution leakage) without reported fatalities or serious injuries, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.

Plain-English summary

B. Braun Medical, Inc. is recalling 1,746,079 units of the 20mm addEASE(TM) Binary Connector with 17 Ga. Needle for use with PAB(R) Containers, product code BC2000. The product is intended for fluid transfer between a Partial Additive Bag (PAB(R)) container and a drug vial. The recall covers specific lot numbers distributed nationwide.

The recall was initiated due to possible solution leakage at the interface of the addEASE(TM) Binary Connector and the PAB(R) bag. An investigation determined that the leakage is the result of a misaligned cannula (needle) on the connector, which pierces the PAB(R) bag stopper to access the solution. This misalignment may result in leakage.

The FDA has classified this as a Class II recall. Users should stop using the affected product and contact B. Braun Medical, Inc. for further instructions.

The recalled product

Product
20mm addEASE(TM) Binary Connector with 17 Ga. Needle for use with PAB(R) Containers, BC2000 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 — Infusion Accessories
Hazard
Affected units
1,746,079

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 (17)

  • Material BC2000
  • Lot numbers 0061275133
  • 0061275135
  • 0061275136
  • 0061279143
  • 0061279144
  • 0061279145
  • 0061279146
  • 0061289059
  • 0061289060
  • 0061289061
  • 0061289062
  • 0061289063
  • 0061289064
  • 0061289065
  • 0061289066
  • 0061289067 and 0061299664.

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 →

Related recalls

Same manufacturer · B. Braun Medical, Inc.

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Same hazard · leakage

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