Z-2978-2018 Class II Terminated
FDA device recall Z-2978-2018 was initiated by Medline Industries, Inc. on April 12, 2017 and is designated Class II. 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 … The recall status is terminated (terminated August 5, 2019). Affected quantity: 15 kits.
Recall Details
- Product Type
- Devices
- Report Date
- September 12, 2018
- Initiation Date
- April 12, 2017
- Termination Date
- August 5, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 15 kits
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.
Distribution Pattern
CA, NM
Code Information
Model: CDS920114F. Lot: 17MB5499