Reported Sep 12, 2018 · Terminated
Laparoscopy CDS
Medline Industries, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Medline Industries, Inc. · 1170 S Northpoint Blvd · Waukegan, IL · 60085-6757
Is this the product you have?
- Laparoscopy CDS
- Lot codes and dates
- ModelCDS920114F
- Lot17MB5499
- Amount recalled
- 15 kits
This recall covers 5 products
The agency filed one notice per product. You are reading one of them; the other 4 are below.
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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