Device product
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, 700cc, 850cc
Z-1687-2026
Product summary
- Event
- Event 98482
- Status
- Ongoing
- Classification
- Class II
- Quantity
- Unavailable
- Official record key
device-enforcement:Z-1687-2026
Official wording
Reason: Infusion sets may contain dull/blunt needle tip, which may be difficult to advance, and/or break.
Code information: UDI(s): 10081317028182 10081317028205 10081317028212 10081317028229 10081317028236 10081317028281
Distribution pattern: 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.
Derived failure modes
-
Unknown
Infusion sets may contain dull/blunt needle tip, which may be difficult to advance, and/or break.