Microtek Medical Smoke Evacuator Tubing Recalled for Unlabeled Latex Packaging
Microtek Medical is recalling smoke evacuator tubing because the packaging contains latex but lacks the required warning label.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the source text describes a labeling error regarding latex packaging without reporting any illnesses or injuries, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Microtek Medical Inc is recalling 32,496 units of sterile smoke evacuator tubing (Reference 24187) distributed nationwide in the United States. The product is 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 a 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."
The affected lot numbers are C9336, C9355, C10005, C10015, C10050, C10065, C10126, C10189, C10214, C10224, C10265, C10320, C11122, C11154, C11270, C11315, C11335, C12051, C12089, C12101, C12121, C12130, C12201, C12268, C12304, C13002, C13018, C13043, C13070, C13093, C13155, C13190, C13228, C13281, C14052, C14147, C14174, and C14195. Users should check their inventory for these lot numbers and contact the recalling firm for instructions on how to return or dispose of the product.
The recalled product
- Product
- TUBING 7/8' X 10', W/WAND & TIP, 24/CS, REF 24187, QTY 24\CS, STERILE EO 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 Operating Rooms, Trauma,
- Manufacturer
- Microtek Medical Inc
- Affected units
- 32,496
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: C9336
- C9355
- C10005
- C10015
- C10050
- C10065
- C10126
- C10189
- C10214
- C10224
- C10265
- C10320
- C11122
- C11154
- C11270
- C11315
- C11335
- C12051
- C12089
- C12101
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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