Recall Z-2979-2018— Medline Industries, Inc.
Class II · Terminated
Class II FDA medical device recall by Medline Industries, Inc., initiated 2017-04-12, terminated 2019-08-05. FDA's recall record names no specific 510(k) clearance for this event. Product: Cardiac Insulation Pad, OPEN HEART CDS. Reason: 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..
- Recalling firm
- Medline Industries, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2017-04-12
- Terminated
- 2019-08-05
- Firm location
- Waukegan, IL, United States
Product description
Cardiac Insulation Pad, OPEN HEART CDS
Reason for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.