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.