Microtek Medical Smoke Evacuator Tubing Set Recalled for Latex Packaging
Microtek Medical is recalling smoke evacuator tubing sets because the packaging contains latex but lacks the required warning label.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a known allergen (latex) in the packaging of a medical device. Per the rubric, allergen mislabeling on common allergens is classified as High (Score 3), particularly when the hazard is a risk of harm (allergic reaction) without reported injuries in the source text.
Plain-English summary
Microtek Medical Inc is recalling specific lots of Tubing Set 7/8" x 6' with 1/4" x 24" tubing (Ref 24136). The recall involves 5,889 units that were distributed nationwide in the United States. The affected products are intended to evacuate smoke created by electrosurgery, laser surgery, or power tool surgical procedures in operating rooms, trauma, endoscopy, and laparoscopy sites.
The recall is being conducted because the cohesive band used to package the devices contains latex, but the product is not labeled as required by 21 CFR 801.437. Specifically, the packaging does not contain the required caution statement: "The Packaging of This Product Contains Natural Rubber Latex Which May Cause Allergic Reactions."
Healthcare facilities and consumers should check their inventory for the specific lot numbers listed in the recall notice. If the product is found, it should be removed from use and returned to the manufacturer or disposed of according to local regulations to prevent potential allergic reactions in latex-sensitive individuals.
The recalled product
- Product
- TUBING SET 7/8" X 6' WITH 1/4" x 24" TUBING, REF 24136, QTY 3/CS, NON STERILE, NO LATEX Intended use: The smoke evacuator and accessories are intended to evacuate the smoke created by electrosurgery, laser surgery, or power tool surgical procedures. Locations include Operatin
- Manufacturer
- Microtek Medical Inc
- Affected units
- 5,889
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- Lot Numbers: C9225
- C9232
- C10239
- C10285
- C11042
- C11129
- C11136
- C11172
- C11209
- C11216
- C11279
- C11300
- C11332
- C12010
- C12023
- C12102
- C12157
- C12194
- C12215
- C12251
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 13 recalled by Microtek Medical Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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