NewDeal Large QWIX Medical Device Recalled Due to Infection Risk

Plain-English summary

NewDeal SA is recalling Large QWIX medical devices, including model numbers 111740S through 121820S. The recall covers specific lot numbers distributed across 19 states, including California, Colorado, Connecticut, Idaho, Kansas, Massachusetts, Maryland, Minnesota, Missouri, Mississippi, North Carolina, New York, Ohio, Oregon, Pennsylvania, South Dakota, Virginia, Washington, and Wisconsin.

The recall was initiated because the use of the impacted product may cause a superficial infection requiring oral antibiotics and wound care, or a deep infection requiring intravenous antibiotics and device removal. The source text does not specify the number of units affected or report any specific illnesses or injuries to date.

Consumers who have purchased or are using these specific model numbers and lot numbers should stop using the product and contact NewDeal SA for further instructions on the recall.

The recalled product

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, 1217

Manufacturer

NewDeal SA

Category

Medical Device — Implantable Device

Hazard

• infection

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Distribution

Related recalls