Z-1337-2015 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- April 8, 2015
- Initiation Date
- March 10, 2015
- Termination Date
- January 21, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 10 units
Product Description
FREEDOMAIRE(R) HELMET SYSTEM WITH SUPER POWER PAK BATTERY, LUMBAR BELT AND MOTOR MODULE, REF 11110STK, 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 contamination, body fluids and microorganisms.
Reason for Recall
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.
Distribution Pattern
US (nationwide) Distribution.
Code Information
Lot Numbers: C10078 and C11056