R¿SCH Curved Reinforced Endotracheal Tube: Rusch Reinforced Endotracheal Tube is designated for o...
FDA Device Recall #Z-1124-2015 — Class II — December 12, 2014
Recall Summary
| Recall Number | Z-1124-2015 |
| Classification | Class II — Moderate risk |
| Date Initiated | December 12, 2014 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Teleflex, Inc. |
| Location | Wayne, PA |
| Product Type | Devices |
| Quantity | 2,292,361 |
Product Description
R¿SCH Curved Reinforced Endotracheal Tube: Rusch Reinforced Endotracheal Tube is designated for oral or nasal intubation and are indicated for airway management. The product may be used to reduce the potential for kinking whenever an unusual positioning of the head or neck is required following intubation.
Reason for Recall
Teleflex Medical has issued an advisory notification for the RUSCH Curved Reinforced Endotracheal Tube because of a discrepancy between the labeled cuff diameter and the actual cuff diameter. The actual product cuff diameter meets required specification.
Distribution Pattern
Nationwide Distribution
Lot / Code Information
product codes: 103902-000035 103902-000040 103902-000045 103902-000050 103902-000055 103902-000060 103902-000065 103902-000070 103902-000075 lot numbers: 13EG10C 13FG15C 13FG34C 13GE30C 13IG03C 13IG31C 13JG22C 13KG11C 13LT18C 14AE04 14AE04C 14CE10 14CE11 14DG05 14FE23C 14HE34 13CG12 13EG11C 13FG03C 13FG32C 13GE29C 13HG16C 13IG15C 13IG31C 13IG32C 13IG34C 13JG14 13JG14C 13KE45 13KG08C 13KG11C 14AE05 14AE05C 14BG15 14BG30 14CE11 14DG05C 14HE34 14IE37C 14IE39 14IE39C 13FG03C 13FG32C 13GE29C 13IG12C 13JG12C 13JG14C 13KG11C 13KG31C 13LG35C 14AG22 14BG09 14CE10C 14CG22 14CG30 14DG07 14DG07C 14EG04 14EG07C 14EG32 14FE23C 14GE30 14HE33 14IE39C 14JG02C 14JG03 13BG28 13CG34C 13EG02C 13FG07C 13FG34C 13GE30C 13IG15C 13IG28C 13IG31C 13JG41 13KG21C 13KG31 14AT20 14CE11 14CG14C 14DG07 14DG13C 14ET22C 14FE23 14HG12 14HG12C 14IE39C 14IG18C 14JG02C 14JG03 13AG34 13BG28 13CG34C 13EG13C 13EG34C 13FG16C 13FG17C 13GE30C 13IG03C 13IG17 13IG18C 13IG28C 13JG22 13JG24 13KG22C 13LG13 14AG10C 14BG15 14BG23 14CE11C 14CG28C 13BG24 13EG02C 13EG36C 13FG32C 13GE30C 13IG16C 13IG20C 13IG31C 13JG12C 13JG14 13KG12C 13KG21C 13KG31 13LG32C 13LT18C 14AE05C 14AG10C 14AT20 14BG07 14BG21 14BG30 14BG30C 14CG28 14CG28C 14DG07 14EG05 14FE23C 14FG26C 14HE33C 14HG11 14IE37C 14IE39C 14JG03 13BG08 13BG25 13CG12 13CG33C 13EG02C 13EG13C 13FG14C 13FG32C 13GE30C 13GG42C 13HE34C 13HG24C 13HT16C 13IG16C 13IG17C 13IG32C 13IG34C 13JG13C 13JG14 13KG11C 13KG20C 13KG21 13LE50C 13LG11 13LG11C 13LG13C 13LG32 13LG32C 14AE05C 14AG22 14CG14C 14DG13C 14FE23C 14FG26C 14HE33C 14HE34C 13JG41 13KG20 13LG12 14AE04 14AG10 14BG13 14BG21 14CG14 14CG22 14DG05 14DG17 14DT03 14EG04 14EG31 14FG18 14FT04 14GE30 14GG30 14IE39 13IG15 13JG22 13JG41 13JG43 13KG31 13LG36 14AG10 14BG07 14BG21 14CE10 14CG30 14EG04 14EG05 14EG32 14GE30 14HG10 14IE37 14JG09 13JG22 13KG11 13LT18 14EG28 14FG26 14HE34 13IG34 14AE05 14EG05 14GG10 14GG30 14HE34 13JG14 14AG22 14EG28 14GE30 14GG09 14IG13 13JG22 14BG09 14DG05 14GG10 14IE39 13JG22 13JG24 14BG23 13JG12 14AT20 14CG28 14EG05 14FG24 14GG10 14IG12 14IG18 13IG34 14AG22 13JG12 13JG29 13KG20 14FG19 14FT04 14GG10 13JG22 14CG30 14FG18
Other Recalls from Teleflex, Inc.
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-1008-2015 | Class I | MAQUET Servo Humidifier 163; Model No.: 01-06-8... | Dec 4, 2014 |
| Z-2411-2015 | Class II | Carlens Bronchial Double Lumen Tube Set (Left) ... | Nov 21, 2014 |
| Z-2408-2015 | Class II | Bronchial Double Lumen Tube Set (Right), Sterile | Nov 21, 2014 |
| Z-2409-2015 | Class II | Bronchial One Lumen Tube - Left | Nov 21, 2014 |
| Z-2407-2015 | Class II | Bronchial Double Lumen Tube Set (Left), Sterile | Nov 21, 2014 |
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.