Microtek Medical recalls sterile smoke evacuator wands due to latex packaging
Microtek Medical is recalling sterile smoke evacuator wands 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 content without reporting any illnesses or injuries, fitting the criteria for a moderate severity labeling issue.
Plain-English summary
Microtek Medical Inc is recalling 9,168 units of the Integral Wand w/Tubing, Sterile (Ref 24185). These sterile smoke evacuator accessories 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 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 units were distributed nationwide in the United States. The recall involves specific lot numbers: C10081, C10138, C10181, C10231, C10235, C11269, C11311, C12005, C12051, C12065, C12143, C12172, C12199, C12363, C13015, C13085, C13148, C13189, C13213, C13240, C13295, C13319, C13365, C14104, and C14167. Users should check their inventory for these lot numbers and contact Microtek Medical for instructions on returning the product.
The recalled product
- Product
- INTEGRAL WAND W/TUBING, STERILE, REF 24185, 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, Endosc
- Manufacturer
- Microtek Medical Inc
- Affected units
- 9,168
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: C10081
- C10138
- C10181
- C10231
- C10235
- C11269
- C11311
- C12005
- C12051
- C12065
- C12143
- C12172
- C12199
- C12363
- C13015
- C13085
- C13148
- C13189
- C13213
- C13240
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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