Z-2213-2016 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- July 27, 2016
- Initiation Date
- March 30, 2016
- Termination Date
- July 15, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- US: 107 cases (48 rolls per case)
Product Description
AMD-RITMED brand Conforming Stretch Gauze Bandages, Sterile, 6 in x 4/1 yds./15 cm x 3.7 cm, Reorder Number/Code D606, Bar code 6 86864 04230 3, Made in China -- Manufactured for & distributed by: AMD-RITMED INC. Montreal Quebec H8T 3J8 -- US Distribution: AMD-RITMED INC. Tonawanda, NY 14150 -- Type of packaging: 1 roll/pouch, 12 pouches/inner box, 4 inner box/case, 48 rolls per case. Conforming bandages used to cover and protect wounds from further injuries and contamination. This type of product fits all parts of the body without restrictive movement. To be used in health care facilities.
Reason for Recall
The product lot did not meet sterility requirements based on FDA sampling and analysis.
Distribution Pattern
US Distribution in states of: NY, CA, and TN.
Code Information
Lot 64155, Expiration Date 2017-06