Thread-like wire marker
Hazard
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.
What You Should Do
Remedy
On 1/22/2021, Somatex issued an Urgent Medical Device Removal notice to customers via e-mail for Tuflex and Tuflex Premium marking wires. This recall has been initiated due to the risk of wire splintering after contact with a cautery device during the removal of a lesion.
Affected by this recall?
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Products
Thread-like wire marker
- Brand
- Somatex Medical Technologies GMBH Hohenzollerndamm 150-151 Berlin Germany
- UPC
- 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.
Units Affected
196 pieces