Recall Z-2978-2018— Medline Industries, Inc.
Class II · Terminated
Class II FDA medical device recall by Medline Industries, Inc., initiated 2017-04-12, terminated 2019-08-05. FDA's recall record names no specific 510(k) clearance for this event. 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..
- Recalling firm
- Medline Industries, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2017-04-12
- Terminated
- 2019-08-05
- Firm location
- Waukegan, IL, United States
Product description
Laparoscopy CDS
Reason for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.