Recall Z-2444-2018— NewDeal SA
Class II · Terminated
Class II FDA medical device recall by NewDeal SA, initiated 2018-05-22, terminated 2019-11-04. It names one FDA 510(k) clearance: K093914. Product: ADVANSYS TTC, Model Numbers: 181011S, 181012S, 181013S, 181014S, 181001S, 181002S, 181003S & 181004S. Reason: Use of the impacted product may cause a superficial infection requiring PO antibiotics and wound care or deep infection requiring IV antibiotics and device removal..
- Recalling firm
- NewDeal SA
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2018-05-22
- Terminated
- 2019-11-04
- Firm location
- St Priest, France
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
ADVANSYS TTC, Model Numbers: 181011S, 181012S, 181013S, 181014S, 181001S, 181002S, 181003S & 181004S
Reason for recall
Use of the impacted product may cause a superficial infection requiring PO antibiotics and wound care or deep infection requiring IV antibiotics and device removal.
Data sourced from openFDA. This site is unofficial and independent of the FDA.