Broncho Flexible Fiberscope, models: 11001BN1, 11002BD1, 11004BC1, and 11009BC1. " Examination and treatment of the trac

FDA device recall Z-0527-2014 · posted 2013-12-17 · Terminated

Recall details

Recalling firm: Karl Storz Endoscopy America Inc
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.
Action taken: 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.
Root cause: Under Investigation by firm
Status: Terminated
Product code: ECQ
Quantity affected: 141 units
Distribution: Nationwide Distribution.
Date initiated: 2013-11-13
Date posted: 2013-12-17
Date terminated: 2014-03-27
Location: Southbridge, MA

Recalls and clearances share one API, with change alerts when new recalls post.

Record	Firm	Date
KSEA RHINO-LARYNGO-BRONCHO-FIBERSCOPE,PEDIATRIC BRONCHO-FIBERSCOPE, AND BRONCHO-FIBERSCOPE,11001RK, 11002BC & 110 (K981458)	Karl Storz Endoscopy	1998-05-20
KARL STORZ RHINO-LARYNGO-BRONCHO FIBERSCOPE, FIBERSCOPE FOR BRONCHOSCOPY (K954797)	KARL STORZ Endoscopy-America, Inc.	1996-01-17
BRONCHO-FIBERSCOPE (K832010)	KARL STORZ Endoscopy-America, Inc.	1983-08-01