CLASS II Device recall · Reported 27 Jul 2016 · FDA Enforcement Report
Conforming Stretch Gauze Bandages, Sterile x 4/1 yds./ x recalled
Amd-Ritmed is recalling Conforming Stretch Gauze Bandages, Sterile x 4/1 yds./ x, distributed in California, New York, Tennessee. The recall was initiated on 30 Mar 2016 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2213-2016
- FDA event ID
- 73696
- Recalling firm
- Amd-Ritmed, Tonawanda, NY
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 30 Mar 2016
- FDA classified
- 15 Jul 2016
- Reported
- 27 Jul 2016
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Sterility
- Device type
- Other Medical Devices
Timeline
| 30 Mar 2016 | Recall initiated by company | |
| 15 Jul 2016 | Classified by FDA | +107 days |
| 27 Jul 2016 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
The product lot did not meet sterility requirements based on FDA sampling and analysis.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
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.
Where it was distributed
US Distribution in states of: NY, CA, and TN.
Questions about this recall
Why was it recalled?
The product lot did not meet sterility requirements based on FDA sampling and analysis.
Which lots are affected?
Lot 64155, Expiration Date 2017-06
Where was it sold?
US Distribution in states of: NY, CA, and TN.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Amd-Ritmed
All 3| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Transparent Dressing - Window with label, 4 " x 4 3/4" recalled | Amd-Ritmed | Sterility | 4 states |
| Device | CLASS II | IMCO Conforming Stretch Gauze Bandages, .1 Yds/ x recalled by Amd Ritmed | Amd Ritmed | Sterility | 7 states |
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