FDA Medical Device Recalls (openFDA)
Medline Industries, Inc.: Cardiac Insulation Pad, OPEN HEART CDS
- Recall number
- Z-2979-2018
- Recalling firm
- Medline Industries, Inc.
- Product
- Cardiac Insulation Pad, OPEN HEART CDS
- Status
- Terminated
- Initiated
- 2017-04-12
- Posted
- not on file
- Terminated
- 2019-08-05
- 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.
- Root cause
- Under Investigation by firm
- Action
- Firm 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
- 77 kits
- Distribution
- CA, NM
- Lot, serial or model codes
- Model: CDS984745C; Lots: 17GD0936, 17FD1655, 17ED3419, 17ED1482, 17ED0636, 17DD0666, 17DD0296, 17AD1912, 16LD3005, 16LD0059, 16JD3201, 16ID3179, 16HD1298, 16GD0779, 16FD3925, 16CD0303 and 16AD4032
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- N/A
- Firm FEI
- 3000717925
- Firm city
- Waukegan
- Firm state
- IL
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28