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
Reported: March 3, 2021 Initiated: January 13, 2021 #Z-1142-2021
Product Description
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
Reason for Recall
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
Details
- Recalling Firm
- Covidien Llc
- Units Affected
- 129 units WW
- Distribution
- Worldwide distribution - US Nationwide distribution in the state of MA and the countries of France, French Guiana, Germany, Luxembourg, Spain, United Kingdom.
- Location
- Mansfield, MA
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Covidien Llc. Units affected: 129 units WW.
Why was this product 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
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on March 3, 2021. Severity: Moderate. Recall number: Z-1142-2021.
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