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Recall Observatory FDA recall evidence

Device product

High Pressure Tubing: REF: 502211002, HP9720E/C, HP9721E/C

Z-2293-2025

June 05, 2025

Class II

Product summary

Firm
Merit Medical Systems, Inc.
Event
Event 97151
Status
Ongoing
Classification
Class II
Quantity
8040
Official record key
device-enforcement:Z-2293-2025

Official wording

Reason: High pressure tubing may relax over time causing it to partially separate from the connector resulting in a void that can trap air in the line. Use of the affected product may result in the trapped air being introduced into the patient.

Code information: REF/UDI-DI/Lot(Expiration): 502211002/I3116954(8/16/2028); HP9720E/C/00884450859889/I3116059(12/10/2027), I3127321(12/30/2027), I3137220(1/28/2028); HP9721E/C/00884450859896/I3116060(12/10/2027)

Distribution pattern: US Nationwide distribution in the states of OH, CA, SD, VA, AZ, MT, TX, MI, FL, TN, PA, NJ, MN, ND, IA, LA, UT, KY, IL, OK, ME, IN, NY, NM, SC, AL, ID, CT, WI, GA, MA, NC, AR, WA.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    High pressure tubing may relax over time causing it to partially separate from the connector resulting in a void that can trap air in the line. Use of the affected product may result in the trapped air being introduced into the patient.