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Terminated

Laparoscopy CDS

FDA Recall Z-2978-2018 · Posted None

Recalling FirmMedline Industries, Inc.
Recall StatusTerminated
Product CodeN/A
Date Initiated2017-04-12
Date Terminated2019-08-05
Product Quantity15 kits

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.

Firm Action

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.

Root Cause

Under Investigation by firm

Distribution Pattern

CA, NM

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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