Z-0727-2017Class II

AMD-Ritmed Transparent Dressing - Window with label, 4 " x 4 3/4" (10 cm x 12 cm), Reorder No./Code A60044-W...

Name: Z-0727-2017 AMD-Ritmed Transparent Dressing - Window with label, 4 " x 4 3/4" (10 cm x 12 cm), Reorder No./Code A60044-W...
Creator: Amd-Ritmed, Inc.
Published: 2016-06-08
License: https://open.fda.gov/license/

Amd-Ritmed, Inc. / initiated 2016-06-08 / Terminated / root cause: manufacturing process

FDA source

Amd-Ritmed, Inc. began a recall of 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... on 2016-06-08. FDA classified it as Class II and gives the reason as "The lot of transparent dressing was found to be contaminated (not sterile) based on FDA sampling and analysis". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0727-2017
Classification: Class II
Status: Terminated
Initiated: 2016-06-08
Posted: 2016-12-08
Terminated: 2017-02-24
Recalling firm: Amd-Ritmed, Inc.
Product: 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
Product code: NAC Dressing, Wound, Hydrophilic
Reason for recall: The lot of transparent dressing was found to be contaminated (not sterile) based on FDA sampling and analysis.
Root cause tag: manufacturing process
FDA root cause: Material/Component Contamination
Action: URGENT: MEDICAL DEVICE RECALL Letter (dated 6/8/2016) was e-mailed to the consignees on 6/8/2016. The recall is being conducted to the retail level. For questions. please contact AMD Customer Service by phone at 1-800-445-0340 or by e-mail at [email protected].
Quantity in commerce: US: 216 cases (200 dressings per case)
Distribution: NY, MA, VA, TN
Product codes and lots: Lot 68408, expiration date 2018¿05

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0727-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0727-2017	Class II	Terminated	Voluntary: Firm initiated	2016-12-14	2016-12-08

Product code NAC

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)