CPX 4 tall height tissue expander infusion needles may be blunt
Mentor is recalling CPX 4 US Breast Tissue Expanders with Suture Tabs in the smooth tall 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 tall height, reference numbers SCPX-113TH, SCPX-123TH, SCPX-140TH and SCPX-146TH in 350 cc, 450 cc, 650 cc and 750 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 10081317028427, 10081317028434, 10081317028458 and 10081317028465.
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-113TH, SCPX-123TH, SCPX-140TH, SCPX-146TH Smooth Tall Height Tissue Expander, 350cc, 450cc, 650cc, 750cc
- Manufacturer
- Mentor Texas, LP.
- Category
- Medical Device — Tissue expander
- Hazard
- needle-defect
- device-breakage
- procedure-risk
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- UDI(s):10081317028427 10081317028434 10081317028458 10081317028465
Distribution
Distributed nationwide across the United States.
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