Z-1869-2017Class II

Elcam Minimal Residual Volume Luer-activated Swabable-stockcock (MRVLS) 4w gxl:w1/r rbls

Name: Z-1869-2017 Elcam Minimal Residual Volume Luer-activated Swabable-stockcock (MRVLS) 4w gxl:w1/r rbls
Creator: Elcam Medical, Inc.
Published: 2017-02-02
License: https://open.fda.gov/license/

Elcam Medical, Inc. / initiated 2017-02-02 / Terminated / root cause: packaging

FDA source

Elcam Medical, Inc. began a recall of Elcam Minimal Residual Volume Luer-activated Swabable-stockcock (MRVLS) 4w gxl:w1/r rbls Product Usage: indicated for fluid flow directional control and for... on 2017-02-02. FDA classified it as Class II and gives the reason as "The stopcock was found to have punctures". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-1869-2017
Classification: Class II
Status: Terminated
Initiated: 2017-02-02
Posted: 2017-04-20
Terminated: 2018-06-08
Recalling firm: Elcam Medical, Inc.
Product: Elcam Minimal Residual Volume Luer-activated Swabable-stockcock (MRVLS) 4w gxl:w1/r rbls Product Usage: indicated for fluid flow directional control and for providing access ports for administration of intravenous solutions. Typical uses include pressure monitoring, intravenous fluid administration and transfusion.
Product code: FMG Stopcock, I.V. Set
Reason for recall: The stopcock was found to have punctures.
Root cause tag: packaging
FDA root cause: Package design/selection
Action: Elcam Medical sent their customers a recall letter/return response form dated February 2, 2017. Elcam is asking customers to examine their inventory for any affected products and to complete the return response form provided. For questions call 201-457-1120 ext. 102 or 201-457-1120 ext. 112.
Quantity in commerce: 810
Distribution: U.S Nationwide Distribution
Product codes and lots: Lot #1670350901

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1869-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1869-2017	Class II	Terminated	Voluntary: Firm initiated	2017-04-26	2017-04-19

Product code FMG

K060231Class IIClosed Swabable Stopcock and Minimal Residual Volume Luer-Activated Swabable-StopcockElcam Medical Acal / cleared 2006-04-13

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)