Z-2155-2017Class II

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

Name: Z-2155-2017 CytoGuard Closed Luer Connector, Intravenous access 2 cartons of 50 units each (100 units per case)
Creator: B Braun Medical Inc
Published: 2017-04-10
License: https://open.fda.gov/license/

B Braun Medical Inc / initiated 2017-04-10 / Terminated / root cause: manufacturing process

FDA source

B Braun Medical Inc began a recall of CytoGuard Closed Luer Connector, Intravenous access 2 cartons of 50 units each (100 units per case) on 2017-04-10. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2155-2017
Classification: Class II
Status: Terminated
Initiated: 2017-04-10
Posted: 2017-05-23
Terminated: 2018-02-02
Recalling firm: B Braun Medical Inc
Product: CytoGuard Closed Luer Connector, Intravenous access 2 cartons of 50 units each (100 units per case)
Product code: FPA Set, Administration, Intravascular
Reason for recall: 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.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: B. Braun mailed an Urgent Medical Device Recall Notice to affected customers to inform them of the issue. Customers were asked to determine their current inventory and to not destroy any of the product; however, product should be discontinued immediately and quarantined and return the acknowledgement form for product return.
Quantity in commerce: 417,600 units
Distribution: United States Nationwide distribution
Product codes and lots: Lot # 1240156001, 1240156002, 1240156003, 1240156004, 1370249001, 1370251101, 1370257101, 1370259201, 1370268401, 1370270401, 1370273801, 1470311101, and 1570315301

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2155-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2155-2017	Class II	Terminated	Voluntary: Firm initiated	2017-05-31	2017-05-23

Product code FPA

K112636Class IICytoguard(tm) Closed Luer ConnectorB.Braun Medical, Inc. / cleared 2011-11-26

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)