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Medline Industries, Inc. recalls Cardiac Insulation Pad, OPEN HEART CDS

Recalled September 12, 2018 · FDA recall Z-2979-2018 · Medline Industries

Hazard
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. · FDA Class II
Units
77 kits
Sold at
CA, NM

Description

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.

Product
Cardiac Insulation Pad, OPEN HEART CDS
Manufacturer(s)
Medline Industries, Inc.

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →

Medline Industries, Inc. recalls Cardiac Insulation Pad, OPEN HEART CDS | RecallWatchUSA