Reported Jan 20, 2016 · Terminated
Medrad Source Administration Sets, Catalog number INT CSS. For use with MEDRAD Intego PET Infusion pump Systems, in…
Bayer Healthcare
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 Healthcare · 1 Bayer Dr · Indianola, PA · 15051-9702
Is this the product you have?
- Medrad Source Administration Sets, Catalog number INT CSS. For use with MEDRAD Intego PET Infusion pump Systems, in nuclear medicine diagnostic procedures.
- Lot codes and dates
50856405508575105086099450866789508679215086946450869465508711315087296550878229508782305087823150878232508813285088139350881394508813955088150650881511508815125088275350886316508864675088646850886469508882855088828650888287508882885088837350890483508904845089048550892357508923585089235950892360600003216000032260000323600006926000078960000790600008336000083460000835
- Amount recalled
- 198,598
Where it was sold
Why it was recalled
The firm's investigation of the Medrad Intego indicates that the inner diameter of the saline tubing is out of specification and may result in the system failing to position the dose correctly during extraction, potentially leading to a low measurement of the extracted dose or to a higher dose being extracted. The occluded SAS tubing may impair the priming function and prompt an RP prime fail
This product could cause temporary or reversible health problems — stop using it.
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