Home / Recalls / Merit Medical Systems, Inc. / Z-3191-2024

Z-3191-2024 Class II Ongoing

Recalled by Merit Medical Systems, Inc. — South Jordan, UT

Recall Details

Product Type
Devices
Report Date
October 2, 2024
Initiation Date
August 12, 2024
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
24

Product Description

Custom Procedure Kit, REF: K12T-11077

Reason for Recall

7F sheath introducers labeled as 7.5F

Distribution Pattern

Worldwide - US Nationwide distribution in the states of WI, MN, TX, PA, GA, NE, CA, AR, MS, MA, MI, OH, CO, NV, OR, AZ, NC and the country of Mexico.

Code Information

REF/UDI-DI/Lot (Expiration Date): K12T-11077/00884450457863/T2908313 (01-DEC-2024)

Other recalls by Merit Medical Systems, Inc.

  • Z-1576-2026 Class I — ProGuide Chronic Dialysis Catheters, REF: DC01455550/C, DC21452419/C, DC21452419 (February 13, 2026)
  • Z-1579-2026 Class I — BioFlo DuraMax Catheter, REF: H965103028011/A, H965103028021/A, H965103028021/EU (February 13, 2026)
  • Z-1577-2026 Class I — 16F Dual Valved Splittable Sheath Introducer (bulk, non-sterile), REF: FCL-174-0 (February 13, 2026)
  • Z-1578-2026 Class I — DuraMax Chronic Hemodialysis Catheter, REF: H787103028015/A, H787103028025/A, H7 (February 13, 2026)
  • Z-1575-2026 Class I — CentrosFLO Hemodialysis Catheters, REF: CENFP15K/A, CENFP15K/B, CENFP17K/A, CENF (February 13, 2026)
  • Z-1129-2026 Class II — Allwell Angioplasty Pack REF: IS-30-B1/B (December 4, 2025)
  • Z-1128-2026 Class II — Merit Medical , Custom Procedure Kit Reference Numbers: K12T-04270A K12T-07956 (December 4, 2025)
  • Z-1126-2026 Class II — Merit Medical , Custom Inflation Kit REF: K05-00761F K05-01717B K05-02080D K05- (December 4, 2025)
  • Z-1123-2026 Class II — Merit Medical Inflation Device.basixCOMPAK.30 atm/bar.20 mL Reference Numbers: (December 4, 2025)
  • Z-1127-2026 Class II — Merit Medical , Custom Manifold Kit REF: K09-13203A (December 4, 2025)