FDA Device recall Z-2978-2018
Laparoscopy CDS
- FDA Device
- Class II
- terminated
- Published 2018-09-12
On 2018-09-12 the FDA classified a Class II recall of Laparoscopy CDS by Medline Industries, citing one manufacturing lot of a non-sterile pack was assembled with a non-sterile component labeled sterile (kit component #80532NS). The non-sterile component 80532NS was supposed to….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2978-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-04-12 |
| Published | 2018-09-12 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Medline Industries |
| Distribution | CA, NM |
Product
Laparoscopy CDS
Reason
One manufacturing lot of a non-sterile pack was assembled with a non-sterile component labeled sterile (kit component #80532NS). The non-sterile component 80532NS was supposed to be placed inside the sterile portion of the pack where it would subsequently be exposed to the ethylene oxide sterilization process. However, the component was not placed in the sterile portion of the pack during assembly and was never exposed to the sterilization process. Component 80532NS was inadvertently released non-sterile. Component 80532NS is packaged by Medline and is an Anti-fog kit that contains 1 bottle of 6g Anti-Fog solution and an adhesive backed sponge.
Identifiers
| code_info | Model: CDS920114F. Lot: 17MB5499 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2978-2018%22
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