Device product
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.
Z-2213-2016
Product summary
- Firm
- Amd-Ritmed, Inc.
- Event
- Event 73696
- Status
- Terminated
- Classification
- Class II
- Quantity
- US: 107 cases (48 rolls per case)
- Official record key
device-enforcement:Z-2213-2016
Official wording
Reason: The product lot did not meet sterility requirements based on FDA sampling and analysis.
Code information: Lot 64155, Expiration Date 2017-06
Distribution pattern: US Distribution in states of: NY, CA, and TN.
Derived failure modes
-
Unknown
The product lot did not meet sterility requirements based on FDA sampling and analysis.