—#159474

Product

Laparoscopy CDS

FDA product code: N/A
Affected lot / code info: Model: CDS920114F. Lot: 17MB5499

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.

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

Firm contacted customers via phone and letter beginning April 12, 2017. Customers were instructed to remove the Ethicon BioPatch Protective Disk with CHG from the kit(s) and return it to the firm. The firm would provide a sterile replacement BioPatch. Affected product will be destroyed.

Recalling firm

Firm: Medline Industries, Inc.
Address: 1170 S Northpoint Blvd, Waukegan, Illinois 60085-6757

Distribution

Distribution pattern: CA, NM

Timeline

Recall initiated: 2017-04-12
Terminated: 2019-08-05
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #159474. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.