Intubation Flexible Fiberscope, Models: 11301AA1, 11301BN1, 11302BD1, 11302BD2, 11304BC1, 11340BC1, 11301BND1, 11302BDD1

FDA device recall Z-0526-2014 · 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

CAL

Quantity affected

1516 units

Distribution

Nationwide Distribution.

Date initiated

2013-11-13

Date posted

2013-12-17

Date terminated

2014-03-27

Location

Southbridge, MA