Events

Recall of Remove and Skin Prep Wipes

According to L’Agence nationale de sécurité du médicament et des produits de santé (ANSM), this recall involved a device in France that was produced by Smith Nephew Lab.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Date
    2011-04-21
  • Event Country
    France
  • Event Source
    ANSM
  • Event Source URL
    https://ansm.sante.fr/S-informer/Informations-de-securite-Retraits-de-lots-et-de-produits/lingettes-remove-et-skin-prep-laboratoire-smith-nephew-retrait-de-lots
  • Notes / Alerts
    French data is current through early September 2018. All of the data comes from L’Agence nationale de sécurité du médicament et des produits de santé (ANSM), except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and France.
  • Extra notes in the data
  • Action
    Smith & Nephew made the decision to voluntarily recall the batches listed below of REMOVE and SKIN-PREP wipes made for Smith & Nephew by TRIAD. This recall decision was made following a recommendation from the FDA. It was determined that these specific batches of products were manufactured in the same manufacturing plant as other alcohol-based wipes manufactured by TRIAD and that are subject to further voluntary recall due to a potential risk bacterial contamination. The relevant European Competent Authorities are informed of this measure by the manufacturer. List of lots concerned. Wording of the product AC Code. Smith & Nephew Reference. Presentatio. Command unit. Lot. REMOV. . 700519.. 5940312.. Wipes impregnated with solvan. . 1 box of 50 sachet. . 0E219, 0E226, 0F242, 0G116, 0H256, 0J233, 0J262, 0J263, 0M178, 0M179, 1A106, 1A181, 1A182, 1A19. . SKIN-PRE. . 700515.. 5942042.. Wipes impregnated. . 1 box of 50 sachet. . 0G117, 0G225, 0J146, 0J147, 0K78, 0M198

Device

Remove and Skin Prep Wipes
  • Model / Serial
  • Product Description
    medical_device
  • Manufacturer
    Smith Nephew Lab

Manufacturer

Smith Nephew Lab
  • Source
    LAANSM