CLASS II Device recall · Reported 14 Dec 2016 · FDA Enforcement Report
Transparent Dressing - Window with label, 4 " x 4 3/4" recalled
Amd-Ritmed is recalling AMD-Ritmed Transparent Dressing - Window with label, 4 " x 4 3/4", distributed in Massachusetts, New York, Tennessee, Virginia. The recall was initiated on 8 Jun 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-0727-2017
- FDA event ID
- 74368
- Recalling firm
- Amd-Ritmed, Tonawanda, NY
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 8 Jun 2016
- FDA classified
- 8 Dec 2016
- Reported
- 14 Dec 2016
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Sterility
- Device type
- Other Medical Devices
Timeline
| 8 Jun 2016 | Recall initiated by company | |
| 8 Dec 2016 | Classified by FDA | +183 days |
| 14 Dec 2016 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
The lot of transparent dressing was found to be contaminated (not sterile) 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 Transparent Dressing - Window with label, 4 " x 4 3/4" (10 cm x 12 cm), Reorder No./Code A60044-W, Sterile -- 200 Dressings per case -- Made in China for AMD-Ritmed Inc. 1200 55th Ave., Lachine, QC H8T 3J8/295 Firetower Road, Tonawanda, NY 14150
Where it was distributed
NY, MA, VA, TN
Questions about this recall
Is Transparent Dressing - Window with label, 4 " x 4 3/4" recalled?
Yes. Amd-Ritmed recalled Transparent Dressing - Window with label, 4 " x 4 3/4" on 8 Jun 2016. The recall is Class II and its status is Terminated. Recall number Z-0727-2017.
Why was it recalled?
The lot of transparent dressing was found to be contaminated (not sterile) based on FDA sampling and analysis.
Which lots are affected?
Lot 68408, expiration date 2018¿05
Where was it sold?
NY, MA, VA, 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 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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