Reported Mar 3, 2021 · Terminated
Covidien Parietex hydrophilic anatomical mesh 15 cm x 10 cm polyester left - Product Usage: designed for the repair of…
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 Parietex hydrophilic anatomical mesh 15 cm
- x 10 cm polyester left - Product Usagedesigned for the repair of inguinal hernias via laparoscopic
- or posterior open procedures Item CodeTECT1510AL
- Lot codes and dates
- Lot NumberSUH0709M
- Amount recalled
- 129 units WW
Where it was sold
- Nationwide
- MA
Why it was recalled
incorrect device is contained in the package. The packaging label indicates that the device is for left side use, the product inside the package is for right side use. Use of an opposite side mesh can result in implant failure and hernia recurrence
This product could cause temporary or reversible health problems — stop using it.
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