Cardiac Insulation Pad — Class II medical device recall Z-2979-2018
Terminated recall by Medline Industries, Inc., reported 2018-09-12, distributed in CA, NM. Complete delivery System (CDS) # CDS984746C was assembled using a non-sterile cardiac insulation pad, Medline
| Recall number | Z-2979-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Medline Industries, Inc., Waukegan, IL, United States |
| Recall initiated | 2017-04-12 |
| Classified | 2018-09-06 |
| Reported by FDA | 2018-09-12 |
| Terminated | 2019-08-05 |
| Distributed | CA, NM |
| Quantity | 77 kits |
| Reason classes | chemical contamination, sterility |
| Lot numbers | 16AD4032, 16CD0303, 16FD3925, 16GD0779, 16HD1298, 16ID3179, 16JD3201, 16LD0059, 16LD3005, 17AD1912, 17DD0296, 17DD0666, 17ED0636, 17ED1482, 17ED3419, 17FD1655, 17GD0936 |
| Model numbers | CDS984745C |
Product
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2979-2018. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.