Reported Jul 15, 2020 · Terminated
RUSCH LASERTUBE (Rubber), RES 102004, Sizes
Teleflex Medical Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: TELEFLEX MEDICAL INC · 3015 Carrington Mill Blvd · Morrisville, NC · 27560-5437
Is this the product you have?
RUSCH LASERTUBE (Rubber), RES 102004, Sizes
5 of 5 products
| Model / number | Product as published |
|---|---|
102004-000040 | I.D. mm 4,0 |
102004-000050 | I.D. mm 5,0 |
102004-000060 | I.D. mm 6,0 |
102004-000070 | I.D. mm 7,0 |
102004-000080 | I.D. mm 8,0, 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. |
- Amount recalled
- 6014 devices
Where it was sold
- Nationwide
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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