Mentor Texas, LP.: Artoura Breast Tissue Expanders Reference Numbers: SDC-100UH SDC-110UH SDC-120UH SDC-130UH SDC-135UH SDC-140UH Smooth Ultra High Profile Tissue Expander, 350cc, 455cc, 535cc, 650cc,

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): 10081317028182 10081317028205 10081317028212 10081317028229 10081317028236 10081317028281

UPC codes

10081317028182, 10081317028205, 10081317028212, 10081317028229, 10081317028236, 10081317028281

Source

Official record: FDA (Device enforcement) ↗

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