—#161837

Product

Situate Gauze RF and X-Ray detectable. Product Number: G0804-16P02CN-1 Situate premium cotton are single use cotton disposable that must be used with the Situate delivery system. The disposable have an attached RF Tag, which is an electrically passive inductor like device that is sewn into the green pouch that you will see on all Situate premium cotton. When activated by magnetic impulses from the scanning devices, the tag resonates a signal that allows for the detection of these cotton disposable.

FDA product code: GDY — Gauze/Sponge, Internal, X-Ray Detectable
Device class: Class 1
Medical specialty: General, Plastic Surgery
Affected lot / code info: Lot Number: 170704A UDI: 20884521700861

Why it was recalled

This voluntary recall is being conducted due to the potential for failure to detect the affected Situate" gauze - RF and Xray detectable products by the Situate" detection console due to a manufacturing error.

Root cause (FDA determination)

Nonconforming Material/Component

Action the firm took

All consignees were notified via FedEx or certified mail on October 12, 2017 and the letter 'Urgent Field Corrective action Notice' informs customers of the potential for failure to detect the affected Situate" gauze RF and X-Ray detectable products by the Situate" detection console and the actions they should take. Customers are requested to acknowledge receipt and understanding of the Urgent Field Correction Action Notice. For further questions, please call (203) 492-5000.

Recalling firm

Firm: Covidien LLC
Address: 60 Middletown Ave, North Haven, Connecticut 06473-3908

Distribution

Distribution pattern: U.S.

Timeline

Recall initiated: 2017-10-12
Terminated: 2020-05-12
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #161837. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.