Reported May 1, 2019 · Terminated
Covidien Endo Clinch II Auto Suture Grasper, 5mm REF: 174317 The Covidien Endo Clinch" II Auto Suture" grasper 5mm has…
Covidien LLC
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: COVIDIEN LLC · 15 Hampshire St · Mansfield, MA · 02048-1113
Is this the product you have?
- Covidien Endo Clinch II Auto Suture Grasper, 5mm
- REF174317 The Covidien Endo Clinch" II Auto Suture" grasper 5mm has a 5 mm diameter, rotating, insulated shaft approximately 31 cm in length and is designed for introduction and use through the appropriately sized Covidien" trocar sleeve or larger sized sleeve with the use of a converter. The atraumatic jaws are clamped and locked onto tissue structures by closing the handles
- Lot codes and dates
- Lot Numbers
P8D1333PRXP8D1334PRXP8D1614PRXP8D1615PRXP8D1616PRXP8E1143PRXP8E1189PRXP8E1269PRXP8E1271PRXP8E1272PRXP8F0008PRXP8F1238PRXP8F1239PRXP8F1307PRXP8F1448PRXP8F1452PRXP8F1480PRXP8F1545PRX
- Lot Numbers
- Amount recalled
- 7248 units
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
Where it was sold
- Nationwide
Why it was recalled
Sterilization method used was not consistent with the labeling and the approved sterilization method
This product could cause temporary or reversible health problems — stop using it.
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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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