Z-0176-2022 Class II Terminated
FDA device recall Z-0176-2022 was initiated by Olympus Corporation of the Americas on September 21, 2021 and is designated Class II. Reason for recall: Due to manufacturing error, the Pneumoliner Bag Distal Tab that exits the Introducer shaft is in the wrong orientation. This results in the user deploying the bag upside down, which will make tissue e… The recall status is terminated (terminated September 8, 2023). Affected quantity: 350 pieces/70 boxes.
Recall Details
- Product Type
- Devices
- Report Date
- November 3, 2021
- Initiation Date
- September 21, 2021
- Termination Date
- September 8, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 350 pieces/70 boxes
Product Description
ASC PneumoLiner device, Part No. WA90500US (US market only) The Pneumoliner device is intended for use as a multiple instrument port and tissue containment system during minimally invasive gynecologic laparoscopic surgery to enable the isolation and containment of tissue, considered benign, resected during single-port or multi- site laparoscopic surgery during power morcellation and removal.
Reason for Recall
Due to manufacturing error, the Pneumoliner Bag Distal Tab that exits the Introducer shaft is in the wrong orientation. This results in the user deploying the bag upside down, which will make tissue encapsulation and bag closure more difficult, introducing the risk of trapping the small bowel/viscera in the bag at closure resulting in patient injury.
Distribution Pattern
US Nationwide distribution to states of: AL, CA, CT, FL, IL, MD, MI, MN, MO, NE, NY, OH, OK, OR, PA, SC, UT, VA, WA, WI, and WV ; and International (foreign) distribution to: Europe.
Code Information
Lots 647572 and 667060