Home / Recalls / Merit Medical Systems, Inc. / Z-0027-2020

Z-0027-2020 Class II Terminated

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

Recall Details

Product Type
Devices
Report Date
October 9, 2019
Initiation Date
October 26, 2018
Termination Date
June 12, 2020
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
24 kits

Product Description

Custom Procedure Kit, Vein Kit, Product Code/REF: K12T-10167, single use, RX Only, Sterile EO, UDI: (01) 00884450390580

Reason for Recall

Labeling error; It was identified that a Procedure Kit/Tray contained incorrect latex labeling information (i.e. indicated Latex Free)

Distribution Pattern

U.S.: VA, IL

Code Information

Catalog # K12T-10167, Lot # K12T-10167, Use By: 2018-11-05

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)