Device Recall Wallace SurePro/ SurePro Ultra Embryo Replacement Catheters

  • Modèle / numéro de série
    Lot Codes: 2000099 2044001 2044005 2117201 2117202 2120953 2138832 2138833 2161554 2304181 2304182 2304199 2305239 2305240 2308138 2313278 2332537 2336956 2336957 2341409 2341410 2344790
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide distribution: USA (Nationwide) and countries of: Arab Emirates (AE) Ireland (IE), Albania, Israel (IL), Argentina (AR),Italy (IT) Armenia (AM) , Japan (JP), Austria (AT) Jordan (JO), Bahrain (BH) Kuwait (KW) Belgium (BE), Lebanon (LB), Belarus , Netherlands (NL), Brazil (BR),Nigeria (NG), Bulgaria (BG) , Pakistan (PK), Canada (CA) Poland (PL), China (CN) Romania (RO), Columbia (CO), Russia (RU), Cyprus(CY) , Saudi Arabia (SA) Czech (CZ) , Singapore (SG), Denmark (OK), South Korea (KR), Egypt (EG), Spain (ES), Finland (FI), Sri Lanka (LK),Germany (DE) Turkey (TR) Ghana (GH) , Uganda (UG), Great Britain (GB) Ukraine (UA), Greece (GR) Uruguay (UY), and Hong Kong (HK).
  • Description du dispositif
    Wallace Sure-Pro/ Sure-Pro Ultra Embryo Replacement Catheters (with ultrasound) || Product Code: PE623 || Sure-Pro¿ Embryo Replacement Catheters are used for the introduction of embryos into the uterine cavity following in vitro fertilization. Sure-Pro Ultra¿ Embryo Replacement Catheters have the added benefit of being visible under ultrasound. These products can be used in either a one- stage or two-stage procedure. In the one-stage procedure, the clinician pushes the inner catheter through the outer sheath and loads the embryo prior to performing the embryo transfer into the uterus. In the two-stage procedure, the clinician places the outer sheath through the cervical canal into the uterus, then loads the embryo in the inner catheter, and advances the inner catheter through the outer sheath to perform the embryo transfer into the uterus.
  • Manufacturer
  • 1 Event

Fabricant

  • Adresse du fabricant
    Smiths Medical ASD, Inc., 10 Bowman Dr, Keene NH 03431-5043
  • Société-mère du fabricant (2017)
  • Source
    USFDA