Microtek Medical Recalls Sterile Laser Resistant Wands Due to Latex Packaging
Microtek Medical Inc is recalling sterile laser resistant 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, which typically corresponds to a moderate severity score. The hazard involves 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 6,540 units of sterile laser resistant wands (Ref 24013) due to a labeling deficiency. 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 units were distributed nationwide in the United States. The specific lot numbers involved are C10102, C10141, C10161, C10326, C10341, C11024, C11055, C11098, C11153, C11215, C11265, C11284, C11326, C11342, C12020, C12101, C12152, C12201, C12276, C12339, C13031, C13100, C13175, C13254, C13291, and C14052. Healthcare facilities should check their inventory for these specific lot numbers and stop using the affected products.
The recalled product
- Product
- LASER RESISTANT WAND - STERILE, 7/8" X 8" (2.22cm x 20.32cm), REF 24013, QTY 10 EA, 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 procedures. Location
- Manufacturer
- Microtek Medical Inc
- Affected units
- 6,540
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: C10102
- C10141
- C10161
- C10326
- C10341
- C11024
- C11055
- C11098
- C11153
- C11215
- C11265
- C11284
- C11326
- C11342
- C12020
- C12101
- C12152
- C12201
- C12276
- C12339
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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