Situate Laparotomy Sponge, RF and X-ray Detectable, REF: L1818-04P01C-1
This recall is currently active, issued March 21, 2024. It was issued by Covidien.
- Company
- Covidien
- Recall Initiated
- February 21, 2024
- Posted
- March 21, 2024
- Recall Number
- Z-1330-2024
- Quantity
- 755,800
- Firm Location
- Lafayette, CO
- Official Source
- View on FDA website ↗
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.
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.
Lot / Code Info
UDI-DI: 20884521700953, 10884521700956. Lots: 230504KF, 220903KF, 221102KF
Root Cause
Labeling mix-ups
Action Taken
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.