Z-1130-2018 Class II Terminated
FDA device recall Z-1130-2018 was initiated by Covidien LLC on October 12, 2017 and is designated Class II. 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 manufact… The recall status is terminated (terminated May 12, 2020). Affected quantity: 20,800.
Recall Details
- Product Type
- Devices
- Report Date
- March 28, 2018
- Initiation Date
- October 12, 2017
- Termination Date
- May 12, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 20,800
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.
Distribution Pattern
U.S.
Code Information
Lot Number: 170704A UDI: 20884521700861