Z-1337-2015 Class II Terminated
FDA device recall Z-1337-2015 was initiated by Microtek Medical Inc on March 10, 2015 and is designated Class II. 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 Packagi… The recall status is terminated (terminated January 21, 2017). Affected quantity: 10 units.
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