Severity
Moderate
FDA Devices recall · Reported May 31, 2017
B. Braun is voluntarily recalling 13 lots of CytoGuard Closed Luer Connector due to a potential for some blisters to be punctured resulting in a compromised sterility barrier.
B Braun Medical Inc recalled CytoGuard Closed Luer Connector, Intravenous access 2 cartons of 50 units each (100 units… - a moderate-severity action.
CytoGuard Closed Luer Connector, Intravenous access 2 cartons of 50 units each (100 units… was recalled by B Braun Medical Inc in May 31, 2017. Reason: B. Braun is voluntarily recalling 13 lots of CytoGuard Closed Luer Connector due to a potential for some blis…. Check the official notice for the remedy. Verify recall #Z-2155-2017 with the FDA Devices before acting.
The recall
B Braun Medical Inc issued this moderate-severity FDA Devices recall-B. Braun is voluntarily recalling 13 lots of CytoGuard Closed Luer Connector due to a potential for some blis….
Sourced from official FDA Devices enforcement records. Verify recall #Z-2155-2017 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
This FDA Devices action (record #Z-2155-2017) was formally reported on May 31, 2017, with the manufacturer initiating the action on April 10, 2017. It is classified under Moderate severity (Class II), with a current status of Terminated. B Braun Medical Inc is listed as the recalling firm, operating out of Breinigsville, PA. Federal records list the affected scope as 417,600 units, a scale large enough to require multi-state distribution tracking.
The documented reason for this recall is: B. Braun is voluntarily recalling 13 lots of CytoGuard Closed Luer Connector due to a potential for some blisters to be punctured resulting in a compromised sterility barrier. Distribution data in the federal record shows the product reached: United States Nationwide distribution. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Severity
Moderate
Affected scope
417,600 units
Related Recalls
6
3 from same agency
CytoGuard Closed Luer Connector, Intravenous access 2 cartons of 50 units each (100 units per case)
B. Braun is voluntarily recalling 13 lots of CytoGuard Closed Luer Connector due to a potential for some blisters to be punctured resulting in a compromised sterility barrier.
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-2155-2017 |
| Date reported | May 31, 2017 |
| Date initiated | April 10, 2017 |
| Recalling firm | B Braun Medical Inc |
| Firm location | Breinigsville, PA |
| Affected scope | 417,600 units |
| Distribution | United States Nationwide distribution |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported May 31, 2017. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.