Device product
CPX 4 US Breast Tissue Expanders with Suture Tabs Reference Numbers: SCPX-107MH, SCPX-117MH,SCPX-127MH, SCPX-135MH, SCPX-146MH, SCPX-156MH Smooth Medium Height Tissue Expander, 275cc, 350cc, 450cc, 550cc, 650cc, 800cc
Z-1683-2026
Product summary
- Event
- Event 98482
- Status
- Ongoing
- Classification
- Class II
- Quantity
- Unavailable
- Official record key
device-enforcement:Z-1683-2026
Official wording
Reason: Infusion sets may contain dull/blunt needle tip, which may be difficult to advance, and/or break.
Code information: 10081317028359 10081317028366 10081317028373 10081317028380 10081317028397 10081317028403
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.