Syringe Kit - Stroke MVSK60Recalls & reported problems

Summary

No MAUDE adverse event reports in our data reference this device identifier directly.

1 FDA recall record name this device's identifier.

10 other recalls cover devices cleared under the same FDA submission (K994253); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Recalls naming this device

1. Oct 20, 2021Terminated

   Syringe Kits labeled for distribution OUS were inadvertently shipped to US customers.

   Z-0202-2022 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K994253. One submission often covers many models, so check the product and lot details in each record.

• Z-0503-2011 · Oct 22, 2010 · Terminated
  VACLOCK Syringe, 10ml, REF: VAC110, Sterile EO, Single Use, Merit Medical Systems, Inc., South Jordan, Utah 84095.
• Z-0505-2011 · Oct 22, 2010 · Terminated
  Merit MEDALLION Syringe, 10ml, REF: MSSW11-R, Sterile EO, Single Use, Merit Medical Systems, Inc., South Jordan, Utah 84095.
• Z-0504-2011 · Oct 22, 2010 · Terminated
  VACLOCK Syringe, 20ml, REF: VAC120E, Sterile EO, Single Use, Merit Medical Systems, Inc., South Jordan, Utah 84095.
• Z-0506-2011 · Oct 22, 2010 · Terminated
  Merit MEDALLION Syringe, 10ml, REF: MSSW11-Y, Sterile EO, Single Use, Merit Medical Systems, Inc., South Jordan, Utah 84095.
• Z-0307-04 · Oct 2, 2003 · Terminated
  EndoReturn arterial cannula. The EndoReturn arterial cannula is indicated for patients undergoing cardiopulmonary bypass. The EndoReturn cannula with hemostasis valve allows for
• Z-0311-04 · Oct 2, 2003 · Terminated
  Introducer Sheath is indicated for patients requiring introduction of catheters. Introducer Sheath for EndoClamp, aortic catheter, 19Fr. IS19 (07042).
• Z-0310-04 · Oct 2, 2003 · Terminated
  SoftClamp II arterial cannula is intended to deliver oxygenated blood for cardiopulmonary bypass during surgery. The product also allows the hemostatic introduction and removal of
• Z-0309-04 · Oct 2, 2003 · Terminated
  DirectFlow arterial cannula is intended to deliver oxygenated blood for cardiopulmonary bypass during surgery. The product also allows the hemostatic introduction and removal of t
• Z-0308-04 · Oct 2, 2003 · Terminated
  EndoReturn arterial cannula. The EndoReturn arterial cannula is indicated for patients undergoing cardiopulmonary bypass. The EndoReturn cannula with hemostasis valve allows for
• Z-0139-04 · Oct 1, 2003 · Terminated
  VacLok Syringe. Label reads in part: ''VACLOC SYRINGE 60 ml VACLOF SYRINGE-FIXED MALE LUER ... MERIT MEDICAL''. Sterile if package is unopened or undamaged. Part #VAC160.