Situate Laparotomy Sponge, RF and X-ray Detectable, REF: L1818-04P01C-1
FDA Recall Z-1330-2024 · Posted 2024-03-21
Recalling FirmCovidien
Recall StatusOpen, Classified
Product CodeGDY
Date Initiated2024-02-21
Product Quantity755,800
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.
Firm 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 [email protected]
Customers with questions can contact the firm at 800-962-9888 Option 2.
Root Cause
Labeling mix-ups
Distribution Pattern
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.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.