Z-0649-2017Class II

Custom Fluid Management Set, Sterile, EO, Rx Only Used to transfer contrast media and saline from a container...

Name: Z-0649-2017 Custom Fluid Management Set, Sterile, EO, Rx Only Used to transfer contrast media and saline from a container...
Creator: Merit Medical Systems, Inc.
Published: 2016-08-12
License: https://open.fda.gov/license/

Merit Medical Systems, Inc. / initiated 2016-08-12 / Terminated / root cause: design

FDA source

Merit Medical Systems, Inc. began a recall of Custom Fluid Management Set, Sterile, EO, Rx Only Used to transfer contrast media and saline from a container to a patients vascular system on 2016-08-12. FDA classified it as Class II and gives the reason as "Merit Medical Systems, Inc. announces a voluntary field action for Fluid Administration Sets due to a molding defect in the drip chamber". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0649-2017
Classification: Class II
Status: Terminated
Initiated: 2016-08-12
Posted: 2016-11-21
Terminated: 2017-05-09
Recalling firm: Merit Medical Systems, Inc.
Product: Custom Fluid Management Set, Sterile, EO, Rx Only Used to transfer contrast media and saline from a container to a patients vascular system.
Product code: FPA Set, Administration, Intravascular
Reason for recall: Merit Medical Systems, Inc. announces a voluntary field action for Fluid Administration Sets due to a molding defect in the drip chamber.
Root cause tag: design
FDA root cause: Component design/selection
Action: Consignees were notified via an Urgent Product Recall Notice on 8/12/16 to: 1. Please immediately determine if any of the devices are within your facility, quarantine them, and discontinue use. 2. Ensure that all personnel to whom the devices were distributed are made aware of this field action. 3. Complete the Customer Response Form and return it to Merit Medical Systems with any affected products. If you have no affected products, please complete the Customer Response Form. 4. E-mail the completed Customer Response Form to Customer Service at [email protected], or fax to (801) 316-4880. 5. If you have any questions concerning this communication or for assistance arranging product return, please dont hesitate to contact your Merit Sales Representative or Vicki Biehn at [email protected] or at (801) 208-4260.
Quantity in commerce: 107,341 total devices
Distribution: Nationwide Distribution.
Product codes and lots: Part Number: 701610001, K08-02053A, K08-02111A, K-08-2192A, K08-02385, K08-02385P, K08-02649, K08-02690, K08-02930a, K08-03044, K08T-02829, K09-00807AD, K09-01467AC, K09-01467AD, K09-01732N, K09-02334N, K09-02608A, K09-03491HP, K09-03586AC, K09-03743L, K09-04300Q, K09-04775HP, K09-04916JP, K09-05525A, K09-05648GP, K09-05993F, K09-07692D, K09-08374C, K09-08485F, K09-08556G, K09-08592N, K09-08603B, K09-08720G, K09-08720H, K09-08743L, K09-08743M, K09-08790C, K09-08813J, K09-09067C, K09-09144B, K09-09221CP, K09-09280A, K09-09326, K09-09418CP, K09-09439, K09-09474H, K09-09527D, K09-09657AP, K09-09672AP, K09-09677A, K09-09683l, K09-09683LP, K09-09859FP, K09-09966AP, K09-09966BP, K09-09983A, K09-10008C, K09-10009D, K09-10312, K09-10457C, K09-10590, K09-10593A, K09-10745BP, K09-10784A, K09-10800CP, K09-10870C, K09-10915F, K09-10947J, K09-10947LP, K09-10992CP, K09-11004F, K09-11004FP, K09-11132CP, K09-11132DP, K09-11137A, K09-11165B, K09-11259B, K09-11270A, K09-11303, K09-11303A, K09-11306, K09-11309D, K09-11336B, K09-11389, K09-11433F, K09-11452AP, K09-11530P, K09-11549D, K09-11655A, K09-11704, K09-11796C, K09-11796CP, K09-11867AP, K09-11901B, K09-11912, K09-11923C, K09-11940AP, K09-11971B, K09-12000, K09-12000A, K09-12006, K09-12065CP, K09-12065D, K09-12065DP, K09-12123A, K09-12138, K09-12138A, K09-12138B, K09-12216, K09-12276, K09-12304, K09-12305, K09-12356, K09-12376, K09-12393, K09-12408, K09-12408A, K09-12421, K09-12431, K09-12529, K09-12530, K09-12530P, K09-12562P, K09-12610, K09-12610P, K09-12647, K09-12689, K09-12698, K09T-03491C, K09T-09672G, K09T-10728C, K09T-11022C, K09T-11410C, K09T-11796C, K09T-11796D, K09T-11940A, K09T-12624, K10-05097A, K11-01028, K11-01376, K12T-06138A, K12T-07389A, and K12T-08215.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0649-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0649-2017	Class II	Terminated	Voluntary: Firm initiated	2016-11-30	2016-11-21

Product code FPA

K915678Class IIMerit Administration SetMerit Medical Systems, Inc. / cleared 1992-07-30

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)