Parietex Composite Mesh Polyester with Absorbable recall
Parietex Composite Mesh Polyester with Absorbable Collagen Film, Horseshoe- Shaped, 9 x 8 cm (3.6" x 3.1"). Intended for the reinforcement of tissues…
Why was Parietex Composite Mesh Polyester with Absorbable recalled?
Collagen film was placed on the opposite side of the mesh may cause delay to treatment/therapy, adhesions, erosion/migration, pain, fistula, hernia (recurrence), and failure of implant
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
GTIN: A8845211784602 Lot Number: PVE0194M
- Product
- Parietex Composite Mesh Polyester with Absorbable Collagen Film, Horseshoe- Shaped, 9 x 8 cm (3.6" x 3.1"). Intended for the reinforcement of tissues…
- Recalling firm
- Covidien, LP
- Quantity
- 53 units
- Distribution
- US Distribution to states of: CA, GA, NY and OUS Foreign distribution to countries of: Armenia, Belgium, France, Germany, Israel, Japan, Luxembourg, Romania, Spain, Switzerland and United Kingdom.
- Recall date
- March 8, 2023
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)