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U.S. Department of Health and Human Services

Class 2 Device Recall Situate Laparotomy Sponge

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  Class 2 Device Recall Situate Laparotomy Sponge see related information
Date Initiated by Firm February 21, 2024
Date Posted March 21, 2024
Recall Status1 Open3, 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 2		 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.
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