FDA Device recall Z-2314-2017
LapSac Introducer, Supplied sterilized by ethylene oxide gas in peel-open packages
- FDA Device
- Class II
- terminated
- Published 2017-06-14
On 2017-06-14 the FDA classified a Class II recall of LapSac Introducer, Supplied sterilized by ethylene oxide gas in peel-open packages by Cook, citing COOK Medical is initiating a voluntary recall of multiple products because the reprocessing instructions do not provide sufficient detailed information for the cleaning, disinfect….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2314-2017 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-05-01 |
| Published | 2017-06-14 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Cook |
| Distribution | US |
Product
LapSac Introducer, Supplied sterilized by ethylene oxide gas in peel-open packages. Used to aid in the introduction of a LapSac during endoscopic surgical procedures.
Reason
COOK Medical is initiating a voluntary recall of multiple products because the reprocessing instructions do not provide sufficient detailed information for the cleaning, disinfection, and sterilization of these products.
Identifiers
| code_info | CATALOG NUMBER: and GPN: J-LSI-102500 & G16500 Dates of Manufacture: February 2012 to December 2016 |
|---|
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-2314-2017%22
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