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Medline Industries, Inc. recalls Laparoscopy CDS

Recalled September 12, 2018 · FDA recall Z-2978-2018 · Medline Industries

Hazard
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. · FDA Class II
Units
15 kits
Sold at
CA, NM

Description

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.

Product
Laparoscopy CDS
Manufacturer(s)
Medline Industries, Inc.

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →

Medline Industries, Inc. recalls Laparoscopy CDS | RecallWatchUSA