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U.S. Department of Health and Human Services

Class 2 Device Recall Broncho Flexible Fiberscope

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  Class 2 Device Recall Broncho Flexible Fiberscope see related information
Date Initiated by Firm November 13, 2013
Date Posted December 17, 2013
Recall Status1 Terminated 3 on March 27, 2014
Recall Number Z-0527-2014
Recall Event ID 66862
510(K)Number K832010  K981458  K954797  
Product Classification Nasopharyngoscope (flexible or rigid) - Product Code ECQ
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 " Uncontrolled hypertension " Bleeding disorder or use of anticoagulants.
Code Information C1140, C1140E, C1160, C1160E, QKC1750, QKC1750E, QKC1694, QKC1694E
Recalling Firm/
Manufacturer		 Karl Storz Endoscopy America Inc
15 Wells St
Southbridge MA 01550-4503
For Additional Information Contact
746-708-8440
Manufacturer 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.
FDA Determined
Cause 2		 Under Investigation by firm
Action The firm, KARL STORZ, sent a "A SAFETY ALERT-ATTENTION NEEDED" letter dated November 8, 2013 to all their customers on November 13, 2013. The letter describes the product, problem and actions to be taken.The letter informs the customers that the endoscopes incorporated a lumen material that is only approved for use as an external surface material and not included in the STERRAD NX and 100NX FDA-cleared claims for use in flexible endoscope lumens. The customers were instructed to follow the recommended processing methods included in the letter. Customers with questions about the letter are instructed to contact the undersigned and the Technical Services at (800) 421-0837, ext 5350.
Quantity in Commerce 141 units
Distribution Nationwide Distribution.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = ECQ and Original Applicant = KARL STORZ ENDOSCOPY
510(K)s with Product Code = ECQ and Original Applicant = KARL STORZ ENDOSCOPY-AMERICA, INC.
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