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.
This recall has been terminated (originally issued October 12, 2017).
- Company
- Covidien Llc
- Recall Initiated
- October 12, 2017
- Terminated
- May 12, 2020
- Recall Number
- Z-1130-2018
- Quantity
- 20,800
- Firm Location
- North Haven, CT
- Official Source
- View on FDA website ↗
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.
Distribution
U.S.
Lot / Code Info
Lot Number: 170704A UDI: 20884521700861
Root Cause
Nonconforming Material/Component
Action Taken
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.