Recall Z-2445-2018— NewDeal SA

Name: FDA recall Z-2445-2018
Creator: U.S. Food and Drug Administration
Published: 2018-05-22

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 MLP/DLP, Model Numbers: 181051S, 181052S, 181041S, 181042S, 181031S, 181032S, 181033S, 181021S, 181022S & 181023S. 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 record

K093914 — NEWDEAL COMPRESSION PLATESNewdeal Sas·cleared 2011-04-14

K-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 MLP/DLP, Model Numbers: 181051S, 181052S, 181041S, 181042S, 181031S, 181032S, 181033S, 181021S, 181022S & 181023S

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.