Covidien Llc Recall 87179
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
Covidien Llc Recall 87179 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-1142-2021 |
| Event ID | 87179 |
| Event 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 |
| Product Type | Devices |
| Distribution | Worldwide distribution - US Nationwide distribution in the state of MA and the countries of France, French Guiana, Germany, Luxembourg, Spain, United Kingdom. |
| Quantity | 129 units WW |
| Recall Reason | 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 |
| Device Classification | 20210303 |
| Device Code Info | Lot Number: SUH0709M |
| Center Classification Date | 20210222 |
| Recall Initiation Date | 20210113 |
| Recalling Firm | Covidien Llc |
| Initial Notification | Letter |
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