Situate Laparotomy Sponge, RF and X-ray Detectable, REF: L1818-04P01C-1

FDA device recall Z-1330-2024 · posted 2024-03-21 · Open, Classified

Recall details

Recalling firm

Covidien

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.

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.

Root cause

Labeling mix-ups

Status

Open, Classified

Product code

GDY

Quantity affected

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.

Date initiated

2024-02-21

Date posted

2024-03-21

Location

Lafayette, CO