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.
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 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)
- Manufacturer
- B Braun Medical Inc
- Hazard
- 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.
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