Merit Medical Systems, Inc.: Custom Fluid Management Set, Sterile, EO, Rx Only Used to transfer contrast media and saline from a container to a patients vascular system.

Recall number

Z-0649-2017

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.

Status

Terminated

Initiated

2016-08-12

Posted

2016-11-21

Terminated

2017-05-09

Reason

Merit Medical Systems, Inc. announces a voluntary field action for Fluid Administration Sets due to a molding defect in the drip chamber.

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 RESPONSE@merit.com, 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 vbiehn@merit.com or at (801) 208-4260.

Quantity

107,341 total devices

Distribution

Nationwide Distribution.

Lot, serial or model codes

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.

510(k) numbers

["K915678"]

PMA numbers

not on file

Product code

FPA

Firm FEI

1721504

Firm city

South Jordan

Firm state

UT

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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