Microtek Medical Recalls Vacuum Tubing Due to Unlabeled Latex Packaging
Microtek Medical Inc is recalling non-sterile vacuum 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, which corresponds to a moderate severity score. The hazard is a labeling error regarding a known allergen (latex) without reported injuries or illnesses in the source text.
Plain-English summary
Microtek Medical Inc is recalling 30,796 units of non-sterile vacuum tubing (7/8" x 6', Ref 24009) due to a labeling defect. The product is intended for use with smoke evacuators in operating rooms, trauma, endoscopy, and laparoscopy sites to evacuate smoke from electrosurgery, laser surgery, or power tool procedures.
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 include the required caution statement: "Caution: The Packaging of This Product Contains Natural Rubber Latex Which May Cause Allergic Reactions."
The affected units were distributed nationwide in the United States. The recall involves specific lot numbers, including C9344, C10091, C10158, and others listed in the official notice. Users should check their inventory for these specific lot numbers and contact the manufacturer for instructions on how to proceed.
The recalled product
- Product
- VACUUM TUBING 7/8" X 6' (2.22cm X 182.88cm), REF 24009, QTY 24\CS, NON-STERILE 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, T
- Manufacturer
- Microtek Medical Inc
- Affected units
- 30,796
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: C9344
- C10091
- C10158
- C10214
- C10221
- C10257
- C10264
- C10298
- C10342
- C11060
- C11104
- C11118
- C11136
- C11180
- C11216
- C11237
- C11290
- C11313
- C11334
- C12060
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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