Freedomaire(r) Motor Module recall
FREEDOMAIRE(R) MOTOR MODULE, REF 11112STK, QTY 1/CS, NON STERILE, NO LATEX The Surgical Helmet System is intended to be worn by surgical personnel to…
Why was Freedomaire(r) Motor Module recalled?
This recall is being conducted because a cohesive band used to package the devices contains latex and the product is not labeled as required by 21 CFR 801.437; it does not contain Caution: The Packaging of This Product Contains Natural Rubber Latex Which May Cause Allergic Reactions.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot Numbers: C11049, C11076, C12339, C13063, C13091, C13109, C13218, C13364
- Product
- FREEDOMAIRE(R) MOTOR MODULE, REF 11112STK, QTY 1/CS, NON STERILE, NO LATEX The Surgical Helmet System is intended to be worn by surgical personnel to…
- Recalling firm
- Microtek Medical Inc
- Quantity
- 38 units
- Distribution
- US (nationwide) Distribution.
- Recall date
- April 8, 2015
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)