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…
- FDA Device
- Class II
- terminated
- Published 2016-07-27
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
| Agency | FDA Device |
|---|---|
| Recall number | Z-2213-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-03-30 |
| Published | 2016-07-27 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Amd Ritmed |
| Distribution | CA, 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_info | Lot 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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