FDA recall Z-2446-2018

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 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.

Distribution

CA, CO, CT, ID, KS, MA, MD, MN, MO, MS, NC, NY, OH, OR, PA, SD, VA, WA & WI

Key facts

Status

Terminated

Initiation date

2018-05-22

Report date

2018-07-25

Termination date

2019-11-04

Voluntary/Mandated

Voluntary: Firm initiated

Location

St Priest, France

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2446-2018