Medline Industries, Inc.: Medical Device Recall in 2018 - (Recall #: Z-2979-2018)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2018.

Data Source: FDA.

Product Description:

Cardiac Insulation Pad, OPEN HEART CDS

Product Classification:

Class II

Date Initiated: April 12, 2017

Date Posted: September 12, 2018

Recall Number: Z-2979-2018

Event ID: 78411

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.

Status: Terminated

Product Quantity: 77 kits

Code Information:

Model: CDS984745C; Lots: 17GD0936, 17FD1655, 17ED3419, 17ED1482, 17ED0636, 17DD0666, 17DD0296, 17AD1912, 16LD3005, 16LD0059, 16JD3201, 16ID3179, 16HD1298, 16GD0779, 16FD3925, 16CD0303 and 16AD4032

Distribution Pattern:

CA, NM

Voluntary or Mandated:

Voluntary: Firm initiated