RecallRadar

FDA Device recall Z-2213-2016

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 042…

On 2016-07-27 the FDA classified a Class II recall of 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 042… by Amd Ritmed, citing the product lot did not meet sterility requirements based on FDA sampling and analysis.

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-2213-2016
ClassificationClass II
Statusterminated
Initiated2016-03-30
Published2016-07-27
Last updated2026-09-13 11:54 UTC
CompanyAmd Ritmed
DistributionCA, NY, TN

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.

Identifiers

code_infoLot 64155, Expiration Date 2017-06

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2213-2016%22

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