Microtek Medical Recalls Freedomaire Surgical Helmets Due to Latex Packaging
Microtek Medical Inc is recalling 153 Freedomaire Surgical Helmets 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: This is an FDA Class II recall involving a labeling error (missing latex warning) which poses a risk of allergic reaction but is not classified as Class I or associated with reported serious injuries.
Plain-English summary
Microtek Medical Inc is recalling 153 units of the Freedomaire Helmet with Motor Module (Ref 11113STK). The product is a non-sterile surgical helmet system intended to be worn by surgical personnel to provide a barrier against contamination, body fluids, and microorganisms. The recall covers specific lot numbers including C9257, C9324, C10025, C10043, C10067, C10165, C10230, C10237, C11321, C11325, C12251, C13063, and C13325.
The recall is being conducted because a cohesive band used to package the devices contains latex. The product is not labeled as required by 21 CFR 801.437, specifically missing the 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. Surgical personnel and facilities should check their inventory for the listed lot numbers and stop using the product if the packaging matches the description. Users with latex allergies should be particularly cautious regarding the packaging materials.
The recalled product
- Product
- FREEDOMAIRE(R) HELMET WITH MOTOR MODULE, REF 11113STK, QTY 1/CS, NON STERILE, NO LATEX The Surgical Helmet System is intended to be worn by surgical personnel to provide barrier between the operating environment and the surgical personnel in order to protect against contaminat
- Manufacturer
- Microtek Medical Inc
- Affected units
- 153
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 (13)
- Lot Numbers: C9257
- C9324
- C10025
- C10043
- C10067
- C10165
- C10230
- C10237
- C11321
- C11325
- C12251
- C13063
- C13325
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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