RUSCH LASERTUBE (Rubber), RES 102004, Sizes: a) I.D. mm 4,0, Product Code 102004-000040 b) I.D....
FDA Device Recall #Z-2533-2020 — Class II — May 29, 2020
Recall Summary
| Recall Number | Z-2533-2020 |
| Classification | Class II — Moderate risk |
| Date Initiated | May 29, 2020 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | TELEFLEX MEDICAL INC |
| Location | Morrisville, NC |
| Product Type | Devices |
| Quantity | 6014 devices |
Product Description
RUSCH LASERTUBE (Rubber), RES 102004, Sizes: a) I.D. mm 4,0, Product Code 102004-000040 b) I.D. mm 5,0, Product Code 102004-000050 c) I.D. mm 6,0, Product Code 102004-000060 d) I.D. mm 7,0, Product Code 102004-000070 e) I.D. mm 8,0, Product Code 102004-000080 Product Usage: Tracheal intubation during laser surgery in the laryngeal area. The tube is resistant to the following kinds of laser: A R+ laser / ND/YAG laser / CO2 lasers (continuous-wave or pulsed) with a wave length ranging from 0.488 ¿m to 10.6 ¿m.
Reason for Recall
Teleflex is initiating a voluntary recall for the above-mentioned products due to reports indicating that the laser guard foil partially separated and/or slightly detached at the edges in the presence of moisture.
Distribution Pattern
US Nationwide distribution.
Lot / Code Information
a) I.D. mm 4,0, Product Code 102004-000040, Lot numbers: 19491, 19501, 19511, 20021, 20041, 20091 b) I.D. mm 5,0, Product Code 102004-000050, Lot numbers: 19471, 19501, 19511, 20021, 20031, 20041, 20051, 20061, 20071, 20101, 20111, 20121 c) I.D. mm 6,0, Product Code 102004-000060, Lot numbers: 19481, 19491, 19501, 20081, 20091, 20101, 20111, 20121, 20131 d) I.D. mm 7,0, Product Code 102004-000070, Lot numbers: 19451, 19461, 19471, 19501, 20021, 20031, 20051, 20091, 20111 e) I.D. mm 8,0, Product Code 102004-000080, Lot numbers: 19451, 19481, 19501, 19511, 20041, 20111, 20121
Other Recalls from TELEFLEX MEDICAL INC
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-1126-2022 | Class II | (1) Gibeck Humid-Vent 2S Flex DC, Product #1773... | Apr 11, 2022 |
| Z-1127-2022 | Class II | (1) Teleflex Flex tube, Product #20011, sterile... | Apr 11, 2022 |
| Z-0628-2022 | Class I | 5 Fr. X 65 cm Arrow-Trerotola PTD Kit, Percutan... | Jan 11, 2022 |
| Z-0625-2022 | Class I | Arrow-Trerotola Over-The-Wire PTD Kit, Percutan... | Jan 11, 2022 |
| Z-0623-2022 | Class I | Arrow-Trerotola Over-The-Wire PTD Kit, Percutan... | Jan 11, 2022 |
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.