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-S58-P85-S85-P100-S100-P70Si97Si)OCS TRACK (58-S58-P80-S80-P)OCS WALL (SP)OCS (115A115CT125CT125A135A135CT145155A165A115AS115CTS)EOC (700700S)EOW 700EOA 700
- Lot codes and dates
3,245 of 3,245 codes
3016423301642330164235988847559888475301642630164263016426750001967-2750001967-2750001967-2750001967-9301642430164243016423301642330164233016423301642330164233016423301642630164263016426301642630164263016426301642630164263016426301642430164263016426301642730164263016426301642630164243016424301642330164243016426301642330164233016423301642330164233016423301642430164243016427301642330164233016426301642630164263016426301642330164233016423
- 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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