Reported May 23, 2018 · Terminated
5mm Endopath Xcel with Optiview Technology, Universal Trocar with Stability Sleeve, 5mm, 100mm shaft length, 2CB5LT
Ethicon Endo-Surgery Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Ethicon Endo-Surgery Inc · 4545 Creek Rd · Blue Ash, OH · 45242-2803
Is this the product you have?
5mm Endopath Xcel with Optiview TechnologyUniversal Trocar with Stability Sleeve5mm100mm shaft length2CB5LT
- Lot codes and dates
- Lots
P4T636P4T63GP4T689P4T708P4T86ZP4T882P4T89NP4T97LP4T994P4TA0TP4TA17P4TA55P4TA70P4TA7RP4TC53P4TC7XP4TC87P4TC8UP4TC93P4TD1YR4003LR40048R4005ZR4010LR4012FR40142R4020PR4021HR4027NR4042XR4045NR4046XR4054H
- Lots
- Amount recalled
- 95233
This recall covers 5 products
The agency filed one notice per product. You are reading one of them; the other 4 are below.
Where it was sold
- Nationwide
- PR
Why it was recalled
Use of the product with insufficient lubrication may prolong surgery due to trocar replacement. In addition, insufficient lubrication could result in a remote chance of introducing a minute particle if repeated insertions of the obturator or laparoscopic device damage the seal.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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