Mentor Texas, LP.: Artoura Breast Tissue Expanders Reference Numbers: SDC-100H SDC-110H SDC-120H SDC-130H SDC-135H SDC-140H SDC-150H SDC-155H Smooth High Profile Tissue Expander, 225cc, 300cc, 375cc,

Hazard

Infusion sets may contain dull/blunt needle tip, which may be difficult to advance, and/or break.

Details from the source

Reason for recall: Infusion sets may contain dull/blunt needle tip, which may be difficult to advance, and/or break. Distribution: Worldwide distribution - US Nationwide and the countries of Canada, Albania, Australia, Austria, Belgium, Bulgaria, Croatia, Denmark, Finland, France, Germany, Iceland, Ireland, Italy, Norway, Pakistan, Poland, Romania, Saudi Arabia, Singapore, Slovakia, Slovenia, Spain, Sweden, Switzerland, Taiwan, United Kingdom, Czech Republic. Lot/code info: UDI(s): 10081317028168 10081317028175 10081317028199 10081317028243 10081317028250 10081317028267 10081317028274 10081317028151

UPC codes

10081317028168, 10081317028175, 10081317028199, 10081317028243, 10081317028250, 10081317028267, 10081317028274, 10081317028151

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.