Microtek Medical Smoke Evacuator Tube Sets Recalled for Latex Packaging
Microtek Medical Inc is recalling sterile smoke evacuator tube sets because the packaging contains latex without 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: This is a Class II recall involving a labeling error regarding a common allergen (latex) where no illnesses or injuries have been reported, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Microtek Medical Inc is recalling 3,180 units of sterile smoke evacuator tube sets (REF 24155) 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 warning: "Caution: The Packaging of This Product Contains Natural Rubber Latex Which May Cause Allergic Reactions."
The affected lot numbers are C10042, C10062, C10099, C10133, C10188, C10264, C10327, C11207, C11221, C11285, C12006, C12019, C12083, C12114, C12135, C12157, C12207, C12347, C13011, C13086, C13126, C13144, C13260, C13289, C13340, and C14037. Users should check their inventory for these specific lot numbers and contact the recalling firm for instructions on how to return or dispose of the product.
The recalled product
- Product
- (S) TUBE SET 1/4" X 10' (0.64 cm X 304.8 cm) with 7/8" (2.22 cm) Adaptor, Sterile, REF 24155, QTY 10/CS, STERILE EO, NO LATEX Intended use: The smoke evacuator and accessories are intended to evacuate the smoke created by electrosurgery, laser surgery, or power tool surgical p
- Manufacturer
- Microtek Medical Inc
- Affected units
- 3,180
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: C10042
- C10062
- C10099
- C10133
- C10188
- C10264
- C10327
- C11207
- C11221
- C11285
- C12006
- C12019
- C12083
- C12114
- C12135
- C12157
- C12207
- C12347
- C13011
- C13086
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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