Recall record at a glance
| Official record | Z-2979-2018 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class II |
| FDA record status | Terminated |
| Recalling firm | Medline Industries, Inc. |
| Report date | Sep 12, 2018 |
| Recall initiation date | Apr 12, 2017 |
| Quantity | 77 kits |
| Location | Waukegan, IL, United States |
Official product description
Cardiac Insulation Pad, OPEN HEART CDS
Why the product was recalled
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.
Distribution information
CA, NM
How to read the classification
FDA Class II indicates a situation in which use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious consequences is remote. The classification shown here comes from the FDA record.
Additional record details
Recall type: Voluntary: Firm initiated. Initial notification: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit.
What to do next
If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.
About this record
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