CPX 4 medium height tissue expander infusion needles may be blunt
Mentor is recalling CPX 4 US Breast Tissue Expanders with Suture Tabs in the smooth medium height range because the infusion sets may contain a dull or blunt needle tip.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Rubric level 3 covers risk-of-harm products where injury has not yet been reported: a needle that may break or fail to advance during a procedure is a hazard, and no injuries are stated in the source.
Plain-English summary
CPX 4 US Breast Tissue Expanders with Suture Tabs, smooth medium height, reference numbers SCPX-107MH, SCPX-117MH, SCPX-127MH, SCPX-135MH, SCPX-146MH and SCPX-156MH in 275 cc to 800 cc, are being recalled. The product was distributed nationwide in the United States and to Canada and more than twenty other countries. The FDA has classified this recall as Class II.
Infusion sets may contain a dull or blunt needle tip, which may be difficult to advance and/or break.
Affected product carries UDIs 10081317028359, 10081317028366, 10081317028373, 10081317028380, 10081317028397 and 10081317028403.
Facilities can identify affected expanders by the reference number and UDI above, and may contact the recalling firm for further information.
The recalled product
- 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
- Manufacturer
- Mentor Texas, LP.
- Category
- Medical Device — Tissue expander
- Hazard
- needle-defect
- device-breakage
- procedure-risk
Distribution
Distributed nationwide across the United States.
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