Recall Z-1130-2018 ยท GDY Gauze/Sponge, Internal, X-Ray Detectable
Covidien LLC
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
| Date | Oct 12, 2017 |
| Status | Terminated |
| 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. |
| Root cause | Nonconforming Material/Component |
| Action | 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. |
| Quantity | 20,800 |
| Distribution | U.S. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.