Recall Z-2213-2016— Amd-Ritmed, Inc.
Class II · Terminated
Class II FDA medical device recall by Amd-Ritmed, Inc., initiated 2016-03-30, terminated 2016-07-15. FDA's recall record names no specific 510(k) clearance for this event. 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.. Reason: The product lot did not meet sterility requirements based on FDA sampling and analysis..
- Recalling firm
- Amd-Ritmed, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2016-03-30
- Terminated
- 2016-07-15
- Firm location
- Tonawanda, NY, United States
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.