Recall Z-1130-2018— Covidien LLC
Class II · Terminated
Class II FDA medical device recall by Covidien LLC, initiated 2017-10-12, terminated 2020-05-12. FDA's recall record names no specific 510(k) clearance for this event. 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.. 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..
- Recalling firm
- Covidien LLC
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2017-10-12
- Terminated
- 2020-05-12
- Firm location
- North Haven, CT, United States
Product description
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.
Reason for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.