Recall Z-2446-2018— NewDeal SA

Name: FDA recall Z-2446-2018
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: Large QWIX, Model Numbers: 111740S, 111745S, 111750S, 111755S, 111760S, 111765S, 111770S, 111775S, 111780S, 111785S, 111790S, 111795S, 111800S, 111805S, 111810S, 111815S, 111820S, 121740S, 121745S, 121750S, 121755S, 121760S, 121765S, 121770S, 121775S, 121780S, 121785S, 121790S, 121795S, 121800S, 121805S, 121810S, 121815S & 121820S. 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

Large QWIX, Model Numbers: 111740S, 111745S, 111750S, 111755S, 111760S, 111765S, 111770S, 111775S, 111780S, 111785S, 111790S, 111795S, 111800S, 111805S, 111810S, 111815S, 111820S, 121740S, 121745S, 121750S, 121755S, 121760S, 121765S, 121770S, 121775S, 121780S, 121785S, 121790S, 121795S, 121800S, 121805S, 121810S, 121815S & 121820S

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.