Device 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.
Z-1130-2018
Product summary
- Firm
- Covidien LLC
- Event
- Event 79296
- Status
- Terminated
- Classification
- Class II
- Quantity
- 20,800
- Official record key
device-enforcement:Z-1130-2018
Official wording
Reason: 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.
Code information: Lot Number: 170704A UDI: 20884521700861
Distribution pattern: U.S.
Derived failure modes
-
Manufacturing or process control
manufacturing error