Reported Jan 23, 2019 · Terminated

MAVIG Portegra or Portegra2 Overhead Counterpoise System (OCS) used in conjunction with the Medrad Stellant CT…

Bayer Medical Care, Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Bayer Medical Care, Inc. · 1 Bayer Dr · Indianola, PA · 15051-9702

Is this the product you have?

  • MAVIG Portegra or Portegra2 Overhead Counterpoise System (OCS) used in conjunction with the Medrad Stellant CT Injection System (Certegra Workstation), Medrad Mark 7 Arterion" Injection System, or Medrad Mark V ProVis Injection System
  • Catalog NumbersCatalog
  • numbers
    • OCS CEIL (58-S
    • 58-P
    • 85-S
    • 85-P
    • 100-S
    • 100-P
    • 70Si
    • 97Si)
    • OCS TRACK (58-S
    • 58-P
    • 80-S
    • 80-P)
    • OCS WALL (S
    • P)
    • OCS (115A
    • 115CT
    • 125CT
    • 125A
    • 135A
    • 135CT
    • 145
    • 155A
    • 165A
    • 115AS
    • 115CTS)
    • EOC (700
    • 700S)
    • EOW 700
    • EOA 700
Lot codes and dates
  • 3,245 of 3,245 codes

    • 3016423
    • 3016423
    • 3016423
    • 59888475
    • 59888475
    • 3016426
    • 3016426
    • 3016426
    • 750001967-2
    • 750001967-2
    • 750001967-2
    • 750001967-9
    • 3016424
    • 3016424
    • 3016423
    • 3016423
    • 3016423
    • 3016423
    • 3016423
    • 3016423
    • 3016423
    • 3016426
    • 3016426
    • 3016426
    • 3016426
    • 3016426
    • 3016426
    • 3016426
    • 3016426
    • 3016426
    • 3016424
    • 3016426
    • 3016426
    • 3016427
    • 3016426
    • 3016426
    • 3016426
    • 3016424
    • 3016424
    • 3016423
    • 3016424
    • 3016426
    • 3016423
    • 3016423
    • 3016423
    • 3016423
    • 3016423
    • 3016423
    • 3016424
    • 3016424
    • 3016427
    • 3016423
    • 3016423
    • 3016426
    • 3016426
    • 3016426
    • 3016426
    • 3016423
    • 3016423
    • 3016423
Amount recalled
16656

Where it was sold

  • Nationwide

Why it was recalled

If the head mount knob is not properly tightened and the operator directly uses the injector head to move the unit, it may become disengaged, causing the injector head to become loose or fall.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Jun 16, 2020 · Data as of Sep 19, 2:55 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.