Home / Recalls / Karl Storz Endoscopy America Inc / Z-0527-2014

Z-0527-2014 Class II Terminated

Recalled by Karl Storz Endoscopy America Inc — Southbridge, MA

Recall Details

Product Type
Devices
Report Date
December 25, 2013
Initiation Date
November 13, 2013
Termination Date
March 27, 2014
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
141 units

Product Description

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 " Uncontrolled hypertension " Bleeding disorder or use of anticoagulants.

Reason for Recall

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.

Distribution Pattern

Nationwide Distribution.

Code Information

C1140, C1140E, C1160, C1160E, QKC1750, QKC1750E, QKC1694, QKC1694E

Other recalls by Karl Storz Endoscopy America Inc

  • Z-0526-2014 Class II — Intubation Flexible Fiberscope, Models: 11301AA1, 11301BN1, 11302BD1, 11302BD2, (November 13, 2013)
  • Z-0465-2014 Class II — Axillent Debakey Grasping Forceps, Part No. 33821DYD In general the surgeons (November 6, 2013)
  • Z-1728-2013 Class II — 27023WU Balloon Catheter, 3 Fr., 2/pkg, sterile, contains latex. The RUSCH (May 31, 2013)
  • Z-1216-2013 Class II — KARL STORZ Photodynamic Diagnosis (PDD) D-Light C System, Instruction Manuals: (August 16, 2012)
  • Z-1311-2013 Class II — Electrode, Roller, Vaporization, 24FR (27050RK/6). Resectoscope accessories ( (June 1, 2009)
  • Z-1313-2013 Class II — Loop, Cutting, 24FR (26050G/6). Resectoscope accessories (ie. electrode, cutt (June 1, 2009)
  • Z-1306-2013 Class II — Electrode, cutting, 24FR (27050G-.30/6). Resectoscope accessories (ie. electr (June 1, 2009)
  • Z-1312-2013 Class II — Electrode, VaporCut, 24FR (27050SG/6). Resectoscope accessories (ie. electrod (June 1, 2009)
  • Z-1315-2013 Class II — Electrode, Cutting, 24FR, 0.30MM (27040G-.30/6). Resectoscope accessories (ie (June 1, 2009)
  • Z-1307-2013 Class II — Electrode, Coag, Pointed, 24FR (27050L/6). Resectoscope accessories (ie. elec (June 1, 2009)