Reported Sep 12, 2018 · Terminated
Cardiac Insulation Pad, OPEN HEART CDS
Medline Industries, 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: Medline Industries, Inc. · 1170 S Northpoint Blvd · Waukegan, IL · 60085-6757
Is this the product you have?
- Cardiac Insulation Pad, OPEN HEART CDS
- Lot codes and dates
- ModelCDS984745C
- Lots
17GD093617FD165517ED341917ED148217ED063617DD066617DD029617AD191216LD300516LD005916JD320116ID317916HD129816GD077916FD392516CD0303 and 16AD4032
- Amount recalled
- 77 kits
This recall covers 5 products
The agency filed one notice per product. You are reading one of them; the other 4 are below.
Where it was sold
Why it was recalled
Complete delivery System (CDS) # CDS984746C was assembled using a non-sterile cardiac insulation pad, Medline component number 32369. The non-sterile component (32369) was placed within the non-sterile portion of the CDS assembly. This component should have been placed inside the sterile portion of the pack where it would have subsequently been exposed to an ethylene oxide sterilization process. This component was not placed in the sterile portion of the pack and was not sterilized, resulting in the inadvertent release of this item in a non-sterile state. The contents of the sterile kit were properly sterilized and the remaining contents of the non-sterile subassembly had the appropriate sterility status based on their intended use.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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