Recall of Parietex Hydrophilic Anatomical Mesh Due to Incorrect Side Labeling
Covidien is recalling Parietex hydrophilic anatomical mesh where the package label indicates left-side use but contains a right-side device. This labeling error can lead to implant failure and hernia recurrence.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device with a risk of harm (implant failure and hernia recurrence) where injury has not yet been reported, fitting the criteria for a High severity score.
Plain-English summary
Covidien LLC is recalling 129 units of Parietex hydrophilic anatomical mesh, item code TECT1510AL, lot number SUH0709M. The product is designed for the repair of inguinal hernias via laparoscopic or posterior open procedures. The recall is due to a packaging error where the label indicates the device is for left-side use, but the product inside the package is for right-side use.
The affected mesh was distributed worldwide, including nationwide distribution in the United States and in France, French Guiana, Germany, Luxembourg, Spain, and the United Kingdom. The source text notes that use of an opposite side mesh can result in implant failure and hernia recurrence.
Healthcare providers and patients should check their inventory and records for this specific lot number and item code. If the product has been used, providers should contact the manufacturer for further instructions. Consumers who have had this specific mesh implanted should consult their healthcare provider.
The recalled product
- Product
- 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
- Manufacturer
- Covidien Llc
- Category
- Medical Device — Surgical Mesh
- Affected units
- 129
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot Number: SUH0709M
Distribution
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