The Recall Desk
HighFDA (Devices)·Z-2155-2017·Announced 2017-05-31

B. Braun Recalls CytoGuard Closed Luer Connectors Due to Sterility Concerns

B. Braun is voluntarily recalling 13 lots of CytoGuard Closed Luer Connectors because some blisters may be punctured, compromising the sterility barrier.

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 involves a risk-of-harm product (compromised sterility barrier) where injury has not yet been reported, which aligns with the High severity criteria.

Plain-English summary

B. Braun Medical Inc is voluntarily recalling 13 lots of CytoGuard Closed Luer Connectors. The recall involves 417,600 units distributed nationwide in the United States. The product is an intravenous access device packaged in cartons of 50 units each.

The recall is being issued due to a potential for some blisters to be punctured, which results in a compromised sterility barrier. The affected lot numbers are 1240156001, 1240156002, 1240156003, 1240156004, 1370249001, 1370251101, 1370257101, 1370259201, 1370268401, 1370270401, 1370273801, 1470311101, and 1570315301.

The source text does not specify instructions for consumers or healthcare providers on how to handle the recalled units, nor does it report any illnesses or injuries associated with the defect.

The recalled product

Product
CytoGuard Closed Luer Connector, Intravenous access 2 cartons of 50 units each (100 units per case)
Affected units
417,600

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 (13)

  • Lot # 1240156001
  • 1240156002
  • 1240156003
  • 1240156004
  • 1370249001
  • 1370251101
  • 1370257101
  • 1370259201
  • 1370268401
  • 1370270401
  • 1370273801
  • 1470311101
  • and 1570315301

Distribution

Distributed nationwide across the United States.