medical Class II Updated 2021-03-17

Somatex Medical Technologies GMBH recalls Thread-like wire marker

Recalled Product

Thread-like wire marker


Hazard / Issue

This recall has been initiated due to the risk of wire splintering after contact with a cautery device during the removal of a lesion. There is a potential risk that wire fragments are not removed during the procedure and stays inside the patient's body.

Issued by

FDA

Affected States: NJ, OH
Lot/Code Info: Tuflex: REF 271640 Affected Lots: 51268, 51414; REF 271641 Affected Lots: 51269, 51410; REF 271642 Affected Lots: 51270, 51411; REF 271643 Affected Lots: 51271, 51412. Tuflex Premium: REF 271650 Affected Lots: 51300; REF 271651 Affected Lots: 51299, 51413; REF 271652 Affected Lots: 51301.
View official government recall

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