FDA-Device2021-03-03Class II
Covidien Parietex hydrophilic anatomical mesh 15 cm x 10 cm polyester left - Product Usage: designed for the repair of inguinal hernias via laparoscopic or posterior open procedures Item Code: TECT1510AL
Covidien Llc
Hazard
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
Sold states
Worldwide distribution - US Nationwide distribution in the state of MA and the countries of France, French Guiana, Germany, Luxembourg, Spain, United Kingdom.
Affected count
129 units WW
Manufactured in
15 Hampshire St, N/A, Mansfield, MA, United States
Products
Covidien Parietex hydrophilic anatomical mesh 15 cm x 10 cm polyester left - Product Usage: designed for the repair of inguinal hernias via laparoscopic or posterior open procedures Item Code: TECT1510AL
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1142-2021Don't want to check this manually?
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