Intubation Flexible Fiberscope, Models: 11301AA1, 11301BN1, 11302BD1, 11302BD2, 11304BC1, 11340BC...

FDA Device Recall #Z-0526-2014 — Class II — November 13, 2013

Recall Summary

Recall Number Z-0526-2014
Classification Class II — Moderate risk
Date Initiated November 13, 2013
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Karl Storz Endoscopy America Inc
Location Southbridge, MA
Product Type Devices
Quantity 1516 units

Product Description

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 visual access to the larynx and tracheobronchial tree.

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.

Lot / Code Information

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

Other Recalls from Karl Storz Endoscopy America Inc

Recall # Classification Product Date
Z-0527-2014 Class II Broncho Flexible Fiberscope, models: 11001BN1, ... Nov 13, 2013
Z-0465-2014 Class II Axillent Debakey Grasping Forceps, Part No. 338... Nov 6, 2013
Z-1728-2013 Class II 27023WU Balloon Catheter, 3 Fr., 2/pkg, sterile... May 31, 2013
Z-1216-2013 Class II KARL STORZ Photodynamic Diagnosis (PDD) D-Light... Aug 16, 2012
Z-1311-2013 Class II Electrode, Roller, Vaporization, 24FR (27050RK/... Jun 1, 2009

Frequently Asked Questions

Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.

Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.

Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.

What Should You Do?

Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.