FDA-Device2018-03-28Class II
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 d
Covidien LLC
Hazard
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.
Sold states
U.S.
Affected count
20,800
Manufactured in
60 Middletown Ave, N/A, North Haven, CT, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1130-2018Don't want to check this manually?
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