The Recall Desk

FDA (Devices) recall action 66862

Karl Storz Endoscopy America Inc recalled 2 products on 2013-12-25

The FDA (Devices) publishes a recall like this one as 2 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 2 pages.

Products
2
Announced
2013-12-25
Critical
0
Units
1,657

Why these products were recalled

KARL STORZ Endoscopy America, Inc. is recalling the Flexible Broncho Fiberscope or a Flexible Intubation Fiberscope with a suction port because the material used in the suction channel portion was thermoplastic polyurethane (TPU), which is not listed in STERRAD systems claims for interior endoscope lumens.

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

1–2 of 2

  • ModerateFDA (Devices)··2013-12-25

    Karl Storz Recalls Flexible Intubation Fiberscopes Due to Material Issue

    Karl Storz Endoscopy America is recalling specific flexible intubation fiberscopes because the suction channel material is incompatible with STERRAD sterilization systems.

    Product
    Intubation Flexible Fiberscope, Models: 11301AA1, 11301BN1, 11302BD1, 11302BD2, 11304BC1, 11340BC1, 11301BND1, 11302BDD1, and 11302BDD2. " Transoral intubation " Transnasal intubation " Evaluation of placement of endotracheal and double lumen endotracheal tubes " Provide visua
    Category
    Distribution
    0 states
  • ModerateFDA (Devices)··2013-12-25

    Karl Storz Recalls Flexible Broncho Fiberscopes Due to Material Issue

    Karl Storz Endoscopy America is recalling 141 flexible broncho fiberscopes because the suction channel material is not listed for STERRAD sterilization systems.

    Product
    Broncho Flexible Fiberscope, models: 11001BN1, 11002BD1, 11004BC1, and 11009BC1. " Examination and treatment of the tracheobronchial tree Contraindications for Bronchoscopy " Uncontrolled angina, uncontrolled heart failure, or serious uncontrolled ventricular arrhythmias " Unc
    Category
    Distribution
    0 states