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U.S. Department of Health and Human Services

Class 2 Device Recall Cardiac Insulation Pad, OPEN HEART CDS

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 Class 2 Device Recall Cardiac Insulation Pad, OPEN HEART CDSsee related information
Date Initiated by FirmApril 12, 2017
Create DateSeptember 06, 2018
Recall Status1 Terminated 3 on August 05, 2019
Recall NumberZ-2979-2018
Recall Event ID 78411
Product Classification unknown device name - Product Code N/A
ProductCardiac Insulation Pad, OPEN HEART CDS
Code Information Model: CDS984745C; Lots: 17GD0936, 17FD1655, 17ED3419, 17ED1482, 17ED0636, 17DD0666, 17DD0296, 17AD1912, 16LD3005, 16LD0059, 16JD3201, 16ID3179, 16HD1298, 16GD0779, 16FD3925, 16CD0303 and 16AD4032
FEI Number 3000717925
Recalling Firm/
Manufacturer		 Medline Industries, Inc.
1170 S Northpoint Blvd
Waukegan IL 60085-6757
For Additional Information ContactKassandra L. Cotner
847-775-6072
Manufacturer 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.
FDA Determined
Cause 2		Under Investigation by firm
ActionFirm contacted customers via phone and letter beginning April 12, 2017. Customers were instructed to remove the Ethicon BioPatch Protective Disk with CHG from the kit(s) and return it to the firm. The firm would provide a sterile replacement BioPatch. Affected product will be destroyed.
Quantity in Commerce77 kits
DistributionCA, NM
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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