Class 2 Device Recall Situate Laparotomy Sponge

• Date Initiated by Firm: February 21, 2024
• Date Posted: March 21, 2024
• Recall Status: Open, Classified
• Recall Number: Z-1330-2024
• Recall Event ID: 94127
• Product Classification: Gauze/sponge, internal, x-ray detectable - Product Code GDY
• Product: Situate Laparotomy Sponge, RF and X-ray Detectable, REF: L1818-04P01C-1
• Code Information: UDI-DI: 20884521700953, 10884521700956. Lots: 230504KF, 220903KF, 221102KF
• Recalling Firm/ Manufacturer: Covidien; 200 Medtronic Dr; Lafayette CO 80026
• Manufacturer Reason for Recall: Packs including 5 laparotomy sponges may contain incorrect product with a blue loop, X-ray detectable feature, and ethylene oxide treatment; however, this incorrect product wasn't steam pre-treated prior to sterilization, and has no RF tag, which if non-sterile, may lead to infection, tissue trauma, and sepsis, and if in the scannable area, would lead a "CLEAR" display.
• FDA Determined Cause: Labeling mix-ups
• Action: On 2/21/24, recall notices were mailed to customers and distributors who were asked to do the following: 1) Do not use impacted products. 2) Remove, quarantine, and return all unused affected product. 3) This communication needs to be passed to all those who need to be aware within your organization where impacted devices have been transferred, and to any other associated organizations that may be impacted by this action. 4) Complete and return the customer confirmation form to rs.gmbmitgfca@medtronic.com Customers with questions can contact the firm at 800-962-9888 Option 2.
• Quantity in Commerce: 755,800
• Distribution: US Nationwide distribution including in the states of AK, AL, AZ, CA, CO, FL, GA, IA, IL, IN, KS, LA, MA, MD, MI, MN, MO, MS, NC, NE, NJ, NM, NY, OH, OK, PA, RI, TN, TX, UT, VA, WA, WI, WV.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.